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1.
J Thorac Dis ; 16(5): 3085-3095, 2024 May 31.
Artigo em Inglês | MEDLINE | ID: mdl-38883677

RESUMO

Background: The investigation of cardiorespiratory fitness in young adults post-coronavirus disease 2019 (COVID-19) is interesting because this information may help in understanding cardiorespiratory function in these populations. Moreover, it helps to know that these impairments possibly interfere with study, learning, and the activities of daily life in young adults post-COVID-19. This study aims to investigate and compare the cardiorespiratory parameters between 6-minute walk test (6MWT) and 1-minute sit-to-stand test (1-min-STST) in healthy young adults and post-COVID-19 and at a 3-month follow-up. Methods: Forty-six young adults were recruited and divided into two groups including healthy young adults in one group (n=23) and post-COVID-19 patients in the other group (n=23). The young adults were assessed for cardiorespiratory parameters including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse oxygen saturation (SpO2), rate of perceived exertion (RPE), and leg fatigue before and after performing a 6MWT and a 1-min STST at baseline and the 3-month follow-up. Test sequences were randomly assigned using the website randomizer.org. Results: Post-COVID-19 had significantly decreased post-HR, post-SBP, post-SpO2, post-RPE, post-leg fatigue, and increased the distance of 6MWT, and number of steps of 1-min-STST when compared with the baseline (P<0.05). However, all parameters of cardiorespiratory could recover and return to the values of healthy young adults by the follow-up at 3 months. Conclusions: Post-COVID-19 who recovered from mild-COVID-19 for about 6 months recovered their cardiorespiratory parameters to the values of healthy young adults.

2.
JMIR Mhealth Uhealth ; 12: e53964, 2024 Jun 03.
Artigo em Inglês | MEDLINE | ID: mdl-38832585

RESUMO

Background: Due to aging of the population, the prevalence of aortic valve stenosis will increase drastically in upcoming years. Consequently, transcatheter aortic valve implantation (TAVI) procedures will also expand worldwide. Optimal selection of patients who benefit with improved symptoms and prognoses is key, since TAVI is not without its risks. Currently, we are not able to adequately predict functional outcomes after TAVI. Quality of life measurement tools and traditional functional assessment tests do not always agree and can depend on factors unrelated to heart disease. Activity tracking using wearable devices might provide a more comprehensive assessment. Objective: This study aimed to identify objective parameters (eg, change in heart rate) associated with improvement after TAVI for severe aortic stenosis from a wearable device. Methods: In total, 100 patients undergoing routine TAVI wore a Philips Health Watch device for 1 week before and after the procedure. Watch data were analyzed offline-before TAVI for 97 patients and after TAVI for 75 patients. Results: Parameters such as the total number of steps and activity time did not change, in contrast to improvements in the 6-minute walking test (6MWT) and physical limitation domain of the transformed WHOQOL-BREF questionnaire. Conclusions: These findings, in an older TAVI population, show that watch-based parameters, such as the number of steps, do not change after TAVI, unlike traditional 6MWT and QoL assessments. Basic wearable device parameters might be less appropriate for measuring treatment effects from TAVI.


Assuntos
Substituição da Valva Aórtica Transcateter , Dispositivos Eletrônicos Vestíveis , Humanos , Substituição da Valva Aórtica Transcateter/instrumentação , Substituição da Valva Aórtica Transcateter/estatística & dados numéricos , Substituição da Valva Aórtica Transcateter/métodos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Masculino , Feminino , Estudos Prospectivos , Dispositivos Eletrônicos Vestíveis/estatística & dados numéricos , Dispositivos Eletrônicos Vestíveis/normas , Idoso de 80 Anos ou mais , Idoso , Estenose da Valva Aórtica/cirurgia , Inquéritos e Questionários , Qualidade de Vida/psicologia
3.
J Comp Eff Res ; 13(7): e230158, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38869839

RESUMO

Aim: The six-minute walk test (6MWT) is a common measure of functional capacity in patients with heart failure (HF). Primary clinical study end points in cardiomyopathy (CM) trials, including transthyretin-mediated amyloidosis with CM (ATTR-CM), are often limited to hospitalization and mortality. Objective: To investigate the relationship between the 6MWT and hospitalization or mortality in CM, including ATTR-CM. Method: A PRISMA-guided systematic literature review was conducted using search terms for CM, 6MWT, hospitalization and mortality. Results: Forty-one studies were identified that reported 6MWT data and hospitalization or mortality data for patients with CM. The data suggest that a greater 6MWT distance is associated with a reduced risk of hospitalization or mortality in CM. Conclusion: The 6MWT is an accepted alternative end point in CM trials, including ATTR-CM.


Assuntos
Cardiomiopatias , Teste de Caminhada , Humanos , Teste de Caminhada/métodos , Cardiomiopatias/fisiopatologia , Cardiomiopatias/diagnóstico , Hospitalização/estatística & dados numéricos , Neuropatias Amiloides Familiares/diagnóstico , Neuropatias Amiloides Familiares/fisiopatologia , Ensaios Clínicos como Assunto/métodos , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/diagnóstico
4.
Curr Oncol ; 31(6): 2974-2984, 2024 May 25.
Artigo em Inglês | MEDLINE | ID: mdl-38920710

RESUMO

Background: Breast cancer is one of the most common tumours and one of the leading causes of death among women in all parts of the world. The aim of this study is to investigate the influence of Nordic walking on the functional capacity of women who have undergone surgery for breast cancer. Methods: The study involved a cohort of women who exercised through Nordic walking for 10 weeks (from March to May 2022). The subjects trained with a licenced instructor (INWA method), with two training sessions per week of 70-80 min each. We collected information on pain, arm mobility, hand grip strength, shoulder joint range of motion bilaterally, circumference of both arms, body mass index, physical activity, aerobic capacity, and endurance. Results: There were 14 women, median age 63. BMI was significantly lower (28.9/28.1; p = 0.013) after training and a difference in shoulder range of motion was better (anteflexion right (142.5/170, p = 0.002), retroflexion right (40/60, p = 0.005), abduction right (135/180, p = 0.005), abduction left (135/180, p = 0.005)). There was no difference in right hand strength, while there was a significant difference in left hand strength (19/20, p = 0.007). A correlation was found between BMI and the six-minute walk test (r = -0.70; p = 0.005). Conclusions: Considering the multidimensionality of the disease itself and the results of this study, we believe that Nordic walking is a favourable and good choice of physical activity for breast cancer patients.


Assuntos
Neoplasias da Mama , Caminhada , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Amplitude de Movimento Articular , Estudos de Coortes , Terapia por Exercício/métodos , Força da Mão
5.
J Clin Med ; 13(11)2024 May 27.
Artigo em Inglês | MEDLINE | ID: mdl-38892850

RESUMO

Background: Permanent tracheostomy because of total laryngectomy surgery entails significant consequences for patients regarding respiratory physiopathology, such as the loss of the filtering, humidifying, and heating of air by the nose. The use of special stomal filters can provide adequate protection of the tracheal-bronchopulmonary system with a reduction in respiratory pathologies. In fact, in most cases, laryngectomy patients are first cigarette smokers who for this reason also already have respiratory diseases such as chronic obstructive pulmonary disease (COPD). Despite the availability of tracheal filters, as reported in the literature, patients often tend to limit their use due to reported breathing difficulties, especially in conditions of intense breathing. Methods: The objective of this clinical study was to evaluate the most suitable stomal filter for laryngectomy patients during physical activity. The filters studied were an INHEALTH device (Blom-Singer SpeakFree HME); two ATOS devices (Provox® Life™ Energy HME and Provox® Life™ Home HME); and an FAHL device (Laryvox HME Sport). Results: For this purpose, the performances of 31 laryngectomy patients, subjected to medium-high physical effort, were analyzed through a standardized pneumological test, the Six Minute Walking Test (6MWT), which involves a sustained walk lasting six minutes, with an evaluation of heart rate, oxygen saturation, and meters traveled every 60 s; furthermore, we examined two subjective indices, namely, the basal and final dyspnea index and the initial and final muscular fatigue index. Conclusions: The multidisciplinary approach of the laryngectomee patient must also take pulmonary rehabilitation into consideration. It is the task of the medical team and speech therapy support to help the patient in the correct choice of HME filters taking into account daily needs.

6.
J Taibah Univ Med Sci ; 19(3): 637-643, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38807964

RESUMO

Objective: Cardiopulmonary endurance is important for comfortably participating in activities of daily living. Exercise tests, such as the 6-minute walk test (6MWT), are commonly used to evaluate cardiopulmonary endurance. We investigated the effects of the Gait Real-Time Analysis Interactive Lab (GRAIL)- and corridor-based 6MWTs on functional performance. Methods: Thirty healthy men were randomly divided into two groups. Group A participants performed a corridor-based 6MWT, followed by a washout period (1 h). Subsequently, they performed the GRAIL-based 6MWT. Group B participants performed the tests in the reverse order of that performed by Group A participants. Results: The corridor-based 6MWT resulted in significantly higher 6MW distance and 6MW speed than the GRAIL-based 6MWT. No significant differences were observed between the two groups in any of the following secondary outcomes: systolic blood pressure, diastolic blood pressure, oxygen saturation, heart rate, dyspnea, and overall fatigue. A strong positive correlation was observed between the 6MW distance and 6MW speed. Conclusion: The corridor- and GRAIL-based 6MWT should not be used interchangeably.

7.
J Neuroeng Rehabil ; 21(1): 92, 2024 May 30.
Artigo em Inglês | MEDLINE | ID: mdl-38816728

RESUMO

OBJECTIVE: Understanding the characteristics related to cardiorespiratory fitness after stroke can provide reference values for patients in clinical rehabilitation exercise. This meta- analysis aimed to investigate the effect of robot-assisted gait training in improving cardiorespiratory fitness in post-stroke patients, compared to conventional rehabilitation training. METHODS: PubMed, EMBASE, Web of Science, Cochrane Database of Systematic Reviews, CBM, CNKI and Wanfang databases were searched until March 18th, 2024. Randomized controlled trials (RCTs) comparing the effectiveness of robot-assisted gait training versus control group were included. The main outcome variable was peak oxygen uptake. 6-minute walking test, peak heart rate, peak inspiratory expiratory ratio as our secondary indicators. RevMan 5.3 software was used for statistical analysis. RESULTS: A total of 17 articles were included, involving 689 subjects. The results showed a significant effect for robot-assisted gait training to improve VO2peak (MD = 1.85; 95% CI: -0.13 to 3.57; p = 0.04) and 6WMT (MD = 19.26; 95% CI: 10.43 to 28.08; p < 0.0001). However, no significant difference favouring robot-assisted gait training were found in HRpeak (MD = 3.56; 95% CI: -1.90 to 9.02; p = 0.20) and RERpeak (MD = -0.01; 95% CI: -0.04 to 0.01; p = 0.34). CONCLUSION: These results showed that robot-assisted gait training may have a beneficial effect in improving VO2peak and 6WMT, with a moderate recommendation level according to the GRADE guidelines.


Assuntos
Marcha , Robótica , Reabilitação do Acidente Vascular Cerebral , Humanos , Reabilitação do Acidente Vascular Cerebral/métodos , Reabilitação do Acidente Vascular Cerebral/instrumentação , Robótica/métodos , Marcha/fisiologia , Terapia por Exercício/métodos , Terapia por Exercício/instrumentação , Aptidão Cardiorrespiratória/fisiologia , Acidente Vascular Cerebral/fisiopatologia , Acidente Vascular Cerebral/complicações , Consumo de Oxigênio/fisiologia
8.
Int J Cardiol Cardiovasc Risk Prev ; 21: 200255, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38737437

RESUMO

Aim: The aim is to discuss efficacy and safety of exercise-based cardiac rehabilitation (CR) programmes in participants with implantable cardiac devices compared with usual care. Methods: MEDLINE, EMBASE and Cochrane databases were searched from inspection till July 15, 2022. Randomized controlled trials were included if they enrolled adult participants with implantable cardiac devices and tested exercise-based CR interventions in comparison with any control. Risk of bias was assessed, and endpoints data were pooled using random-effects model. Results: Sixteen randomized trials enrolling 2053 participants were included. Study interventions differed between studies in terms of programme components, setting, exercise intensity, and follow-up. All studies included physical exercise component. In both implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy (CRT) groups, exercise training in CR programmes improved peak oxygen uptake (VO2) [(mean difference (MD) 2.08 ml/kg/min; 95 % CI: 1.44-2.728, p < 0.0001; I2 = 99 %) and (MD 2.24 ml/kg/min; 95 % CI: 1.43-3.04, p < 0.0001; I2 = 96 %), respectively] and 6-min walk test in ICD group (MD 41.51 m; 95 % CI: 15.19-67.82 m, p = 0.002; I2 = 95 %) compared with usual care. In CRT group, there was no statistically significant improvement in left ventricular ejection fraction change between comparison groups. The results were consistent in subgroup analysis according to high or low-to-moderate exercise intensity for change in peak VO2 and ejection fraction in CRT group. There was no difference in number of ICD shocks between the comparators. Conclusion: Exercise-based CR programmes appear to be safe when enrolling participants with implantable cardiac devices and leading to favourable functional outcomes.

9.
Artigo em Inglês | MEDLINE | ID: mdl-38685578

RESUMO

INTRODUCTION: Cardiopulmonary exercise testing (CPET) is the gold standard for measuring exercise capacity, however, it is resource intensive and has limited availability. This study aimed to determine: 1) the association between the 6-min walk test (6MWT) and the 30-s sit-to-stand test (30STS) with CPET peak oxygen uptake (VO2peak) and anaerobic threshold (AT) and 2) 6MWT and 30STS cut points associated with a higher risk of postoperative complications. METHODS: A cross-sectional study, retrospectively analyzing data collected from a tertiary cancer center over a 23-month period. Measures included CPET VO2peak and AT, 6MWT and 30STS test. Correlations were used to characterize relationships between variables. Receiver operating characteristic curve analyses determined 6MWT and 30STS cut points that aligned with CPET variable cut points. RESULTS: Note that, 156 participants were included. The 6MWT and 30STS displayed moderate correlations with VO2peak, rho = 0.65, p = 0.01 and rho = 0.52, p < 0.005 respectively. Fair correlations were observed between AT and 6MWT (rho = 0.36, p = 0.01) and 30STS (rho = 0.41, p < 0.005). The optimal cut points to identify VO2peak < 15 mL/kg/min were 493.5 m on the 6MWT and 12.5 stands on the 30STS test and for AT < 11 mL/kg/min were 506.5 m on the 6MWT and 12.5 stands on the 30STS test. CONCLUSION: Both the 6MWT and 30STS test could be used as alternative tools for measuring exercise capacity preoperatively in the cancer setting where CPET is not available. A range of 6MWT and 30STS cut points, according to sensitivity and specificity levels, may be used to evaluate risk of postoperative outcomes.

10.
Sensors (Basel) ; 24(8)2024 Apr 20.
Artigo em Inglês | MEDLINE | ID: mdl-38676249

RESUMO

As a result of technological advancements, functional capacity assessments, such as the 6-minute walk test, can be performed remotely, at home and in the community. Current studies, however, tend to overlook the crucial aspect of data quality, often limiting their focus to idealised scenarios. Challenging conditions may arise when performing a test given the risk of collecting poor-quality GNSS signal, which can undermine the reliability of the results. This work shows the impact of applying filtering rules to avoid noisy samples in common algorithms that compute the walked distance from positioning data. Then, based on signal features, we assess the reliability of the distance estimation using logistic regression from the following two perspectives: error-based analysis, which relates to the estimated distance error, and user-based analysis, which distinguishes conventional from unconventional tests based on users' previous annotations. We highlight the impact of features associated with walked path irregularity and direction changes to establish data quality. We evaluate features within a binary classification task and reach an F1-score of 0.93 and an area under the curve of 0.97 for the user-based classification. Identifying unreliable tests is helpful to clinicians, who receive the recorded test results accompanied by quality assessments, and to patients, who can be given the opportunity to repeat tests classified as not following the instructions.

11.
J Neuromuscul Dis ; 11(3): 579-612, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38669554

RESUMO

Objective: The objective of this study was to describe predictors of loss of ambulation in Duchenne muscular dystrophy (DMD). Methods: This systematic review and meta-analysis included searches of MEDLINE ALL, Embase, and the Cochrane Database of Systematic Reviews from January 1, 2000, to December 31, 2022, for predictors of loss of ambulation in DMD. Search terms included "Duchenne muscular dystrophy" as a Medical Subject Heading or free text term, in combination with variations of the term "predictor". Risk of bias was assessed using the Newcastle-Ottawa Scale. We performed meta-analysis pooling of hazard ratios of the effects of glucocorticoids (vs. no glucocorticoid therapy) by fitting a common-effect inverse-variance model. Results: The bibliographic searches resulted in the inclusion of 45 studies of children and adults with DMD from 17 countries across Europe, Asia, and North America. Glucocorticoid therapy was associated with delayed loss of ambulation (overall meta-analysis HR deflazacort/prednisone/prednisolone: 0.44 [95% CI: 0.40-0.48]) (n = 25 studies). Earlier onset of first signs or symptoms, earlier loss of developmental milestones, lower baseline 6MWT (i.e.,<350 vs. ≥350 metres and <330 vs. ≥330 metres), and lower baseline NSAA were associated with earlier loss of ambulation (n = 5 studies). Deletion of exons 3-7, proximal mutations (upstream intron 44), single exon 45 deletions, and mutations amenable of skipping exon 8, exon 44, and exon 53, were associated with prolonged ambulation; distal mutations (intron 44 and downstream), deletion of exons 49-50, and mutations amenable of skipping exon 45, and exon 51 were associated with earlier loss of ambulation (n = 13 studies). Specific single-nucleotide polymorphisms in CD40 gene rs1883832, LTBP4 gene rs10880, SPP1 gene rs2835709 and rs11730582, and TCTEX1D1 gene rs1060575 (n = 7 studies), as well as race/ethnicity and level of family/patient deprivation (n = 3 studies), were associated with loss of ambulation. Treatment with ataluren (n = 2 studies) and eteplirsen (n = 3 studies) were associated with prolonged ambulation. Magnetic resonance biomarkers (MRI and MRS) were identified as significant predictors of loss of ambulation (n = 6 studies). In total, 33% of studies exhibited some risk of bias. Conclusion: Our synthesis of predictors of loss of ambulation in DMD contributes to the understanding the natural history of disease and informs the design of new trials of novel therapies targeting this heavily burdened patient population.


Assuntos
Glucocorticoides , Proteínas de Ligação a TGF-beta Latente , Distrofia Muscular de Duchenne , Distrofia Muscular de Duchenne/tratamento farmacológico , Humanos , Glucocorticoides/uso terapêutico , Caminhada , Pregnenodionas/uso terapêutico
12.
Cell Rep Med ; 5(4): 101473, 2024 Apr 16.
Artigo em Inglês | MEDLINE | ID: mdl-38537636

RESUMO

We report a randomized, multicenter, open-label trial (ClinicalTrials.gov: NCT03096613) to investigate the clinical benefits of levothyroxine (L-T4) administration in subclinical hypothyroidism (SCH) patients with heart failure with reduced ejection fraction (HFrEF). Overall, 117 patients were enrolled and received L-T4 plus standard HFrEF treatment (experimental group, N = 57) or standard HFrEF therapy alone (control group, N = 60). The change of 6-min walk test distance in the experimental group was significantly higher than that in the control group at 24 weeks (70.08 ± 85.76 m vs. 27.73 ± 82.00 m, mean difference [95% confidence interval (CI)] 46.90 [12.90, 80.90], p < 0.001). Improvements in New York Heart Association (NYHA) classification (p = 0.033) and thyroid function were significant. Adverse event incidence was similar between groups (risk ratio [95% CI]: 0.942 1.053 (0.424, 2.616); p = 0.628). L-T4 addition to HFrEF treatment improved activity tolerance, NYHA class, and thyroid function within 6 months, suggesting its potential for combined therapy in HFrEF patients with SCH. Future double-blind, placebo-controlled trials should be performed to confirm these results.


Assuntos
Insuficiência Cardíaca , Hipotireoidismo , Humanos , Método Duplo-Cego , Hipotireoidismo/tratamento farmacológico , Volume Sistólico , Tiroxina/uso terapêutico
13.
BMC Sports Sci Med Rehabil ; 16(1): 38, 2024 Feb 07.
Artigo em Inglês | MEDLINE | ID: mdl-38321506

RESUMO

BACKGROUND: Hypertension, type 2 diabetes, and cardiovascular disease affect the activities of daily living at varying degree. While the effects of aerobic exercise on functional capacity are well-documented, the extent of change for different types of exercise in these chronic conditions remains unexplored. Additionally, there is conflicting evidence regarding the role of exercise in reducing body weight. METHODS: We conducted systematic review with meta-analysis and trial sequential analysis and searched various databases from inception to July 2020. We included randomised clinical trials adding any form of trialist defined exercise to usual care versus usual care in people with either hypertension, type 2 diabetes, and/or cardiovascular disease irrespective of setting, publication status, year, and language. The outcomes assessed were i) functional capacity assessed through different scales separately i.e., Maximal Oxygen Uptake (VO2max), 6-min walk test (6MWT), 10-m walk test (10MWT), and ii) body weight. RESULTS: We included 950 studies out of which 444 trials randomising 20,098 participants reported on various functional outcomes (355 trials) and body weight (169 trials). The median follow-up was 3 months (Interquartile ranges (IQR): 2.25 to 6). Exercise added to the usual care, improved VO2max (Mean Difference (MD):2.72 ml/kg/min; 95% Confidence Interval (CI) 2.38 to 3.06; p < 0.01; I2 = 96%), 6MWT (MD: 42.5 m; 95%CI 34.95 to 50.06; p < 0.01; I2 = 96%), and 10MWT (MD: 0.06 m/s; 95%CI 0.03 to 0.10; p < 0.01; I2 = 93%). Dynamic aerobic and resistance exercise showed a consistent improvement across various functional outcomes, whereas body-mind therapies (MD: 3.23 ml/kg/min; 95%CI 1.97 to 4.49, p < 0.01) seemed especially beneficial for VO2max and inspiratory muscle training (MD: 59.32 m; 95%CI 33.84 to 84.80; p < 0.01) for 6MWT. Exercise yielded significant reduction in body weight for people with hypertension (MD: -1.45 kg; 95%CI -2.47 to -0.43; p < 0.01), and type 2 diabetes (MD: -1.53 kg; 95%CI -2.19 to -0.87; p < 0.01) but not for cardiovascular disease with most pronounced for combined exercise (MD: -1.73 kg; 95%CI -3.08 to -0.39; p < 0.05). The very low certainty of evidence warrants cautious interpretations of the results. CONCLUSION: Exercise seemed to improve functional capacity for people with hypertension, type 2 diabetes, and/or cardiovascular disease but the effectiveness seems to vary with different forms of exercise. The potentially superior improvement in VO2max and 6MWT by body-mind therapies and inspiratory muscle training calls for further exploration. Additionally, prescribing exercise for the sole purpose of losing weight may be a potential strategy for people with hypertension and type 2 diabetes. The extent of improvement in functional capacity and body weight reduction differed with different exercise regimens hence personalised exercise prescriptions tailored to individual needs may be of importance. PROSPERO REGISTRATION: PROSPERO registration number: CRD42019142313.

14.
Am J Respir Crit Care Med ; 209(6): 647-669, 2024 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-38174955

RESUMO

Background: Idiopathic pulmonary fibrosis (IPF) carries significant mortality and unpredictable progression, with limited therapeutic options. Designing trials with patient-meaningful endpoints, enhancing the reliability and interpretability of results, and streamlining the regulatory approval process are of critical importance to advancing clinical care in IPF. Methods: A landmark in-person symposium in June 2023 assembled 43 participants from the US and internationally, including patients with IPF, investigators, and regulatory representatives, to discuss the immediate future of IPF clinical trial endpoints. Patient advocates were central to discussions, which evaluated endpoints according to regulatory standards and the FDA's 'feels, functions, survives' criteria. Results: Three themes emerged: 1) consensus on endpoints mirroring the lived experiences of patients with IPF; 2) consideration of replacing forced vital capacity (FVC) as the primary endpoint, potentially by composite endpoints that include 'feels, functions, survives' measures or FVC as components; 3) support for simplified, user-friendly patient-reported outcomes (PROs) as either components of primary composite endpoints or key secondary endpoints, supplemented by functional tests as secondary endpoints and novel biomarkers as supportive measures (FDA Guidance for Industry (Multiple Endpoints in Clinical Trials) available at: https://www.fda.gov/media/162416/download). Conclusions: This report, detailing the proceedings of this pivotal symposium, suggests a potential turning point in designing future IPF clinical trials more attuned to outcomes meaningful to patients, and documents the collective agreement across multidisciplinary stakeholders on the importance of anchoring IPF trial endpoints on real patient experiences-namely, how they feel, function, and survive. There is considerable optimism that clinical care in IPF will progress through trials focused on patient-centric insights, ultimately guiding transformative treatment strategies to enhance patients' quality of life and survival.


Assuntos
Fibrose Pulmonar Idiopática , Defesa do Paciente , Humanos , Fibrose Pulmonar Idiopática/tratamento farmacológico , National Institutes of Health (U.S.) , Qualidade de Vida , Reprodutibilidade dos Testes , Estados Unidos , Capacidade Vital , Ensaios Clínicos como Assunto
15.
Mult Scler ; 30(1): 103-112, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38084497

RESUMO

INTRODUCTION: Multiple sclerosis (MS) is a leading cause of disability among young adults, but standard clinical scales may not accurately detect subtle changes in disability occurring between visits. This study aims to explore whether wearable device data provides more granular and objective measures of disability progression in MS. METHODS: Remote Assessment of Disease and Relapse in Central Nervous System Disorders (RADAR-CNS) is a longitudinal multicenter observational study in which 400 MS patients have been recruited since June 2018 and prospectively followed up for 24 months. Monitoring of patients included standard clinical visits with assessment of disability through use of the Expanded Disability Status Scale (EDSS), 6-minute walking test (6MWT) and timed 25-foot walk (T25FW), as well as remote monitoring through the use of a Fitbit. RESULTS: Among the 306 patients who completed the study (mean age, 45.6 years; females 67%), confirmed disability progression defined by the EDSS was observed in 74 patients, who had approximately 1392 fewer daily steps than patients without disability progression. However, the decrease in the number of steps experienced over time by patients with EDSS progression and stable patients was not significantly different. Similar results were obtained with disability progression defined by the 6MWT and the T25FW. CONCLUSION: The use of continuous activity monitoring holds great promise as a sensitive and ecologically valid measure of disability progression in MS.


Assuntos
Pessoas com Deficiência , Esclerose Múltipla , Dispositivos Eletrônicos Vestíveis , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação da Deficiência , Esclerose Múltipla/diagnóstico , Teste de Caminhada , Caminhada/fisiologia , Adulto
16.
J Investig Med ; 72(1): 151-158, 2024 01.
Artigo em Inglês | MEDLINE | ID: mdl-37804162

RESUMO

Coronary artery disease is one of the main causes of mortality and morbidity among chronic heart diseases worldwide. Patients reported chronic chest pain as the primary symptom of coronary artery disease. Due to its progressive nature, it affects the health status and functional capacity of the patients. The current study was planned to compare the effects of prehabilitation resistance training in mild to moderate clinically frail patients awaiting coronary artery bypass graft (CABG). A randomized controlled trial was conducted on 74 patients awaiting CABG at the Faisalabad Institute of Cardiology, Faisalabad, Pakistan. A Modified Healthy Heart Questionnaire was used for screening of the patients. Interventions applied were resistance training by using cuff weights/dumbbells at light intensity (40%-50%) of a maximum of one repetition (10-15 repetitions for one to three times a day) per major muscle groups of upper and lower limbs of the body on weekly basis. The main outcome measures were the 6-minute walk test (6MWT), the New York Heart Association (NYHA) for heart failure, the clinical frailty score, and the essential frailty toolset. Significant differences between group A (resistance training group) and group B (conventional physical therapy group) patients were observed. The mean ranks for 6MWT in group A and group B were 1.70 and 1.55, respectively. The mean ranks of NYHA in group A and group B were 1.68 and 2.84, respectively. Clinical frailty scores in group A and group B were 2.68 and 2.74, respectively, with the essential frailty toolset in group A and group B were 1.14 and 1.11, respectively. There were significant (p < 0.05) differences within and between groups for prehabilitation resistance training after CABG. The study showed that the resistance training group had improved the clinical frailty score, strength, endurance, and functional capacity in patients who underwent elective CABG.


Assuntos
Doença da Artéria Coronariana , Fragilidade , Treinamento Resistido , Humanos , Idoso , Doença da Artéria Coronariana/cirurgia , Idoso Fragilizado , Exercício Pré-Operatório , Ponte de Artéria Coronária
17.
Sensors (Basel) ; 23(24)2023 Dec 05.
Artigo em Inglês | MEDLINE | ID: mdl-38139470

RESUMO

Health-oriented physical activity should meet two key criteria: safety and an optimal level of exercise. The system of monitoring and rationalization of training (SMART) was designed to meet them. SMART integrates a custom-configured inertial measurement unit (IMU) and a sensor with real-time heart rate measurement (HR) using a proprietary computer application. SMART was used to evaluate the safety and exercise load with 115 study participants: 51 women (44.35%) and 64 men (55.65%) aged 19 to 65 years. The exercise test was the 6MWT test. In 35% of the participants, the mean HR exceeded the recognized safe limit of HR 75% max. Ongoing monitoring of HR allows for optimal exercise and its safety. Step count data were collected from the SMART system. The average step length was calculated by dividing the distance by the number of steps. The aim of the present study was to assess the risk of excessive cardiovascular stress during the 6MWT test using the SMART system.


Assuntos
Tolerância ao Exercício , Racionalização , Masculino , Adulto , Humanos , Feminino , Tolerância ao Exercício/fisiologia , Exercício Físico , Teste de Esforço , Frequência Cardíaca/fisiologia
18.
SEMERGEN, Soc. Esp. Med. Rural Gen. (Ed. Impr.) ; 49(8): [e102039], nov.-dic. 2023. tab
Artigo em Inglês | IBECS | ID: ibc-228027

RESUMO

Objective To compare the effects of physical activity on improving health-related quality of life (HRQOL), six minutes walking test (6MWT), and oxygen consumption (VO2) peak before and during Coronavirus disease (COVID-19) in patients with heart failure. Methods Following PRISMA guidelines, we searched for relevant articles from five databases, including Embase, MEDLINE, CINAHL, PEDro, Cochrane, and additional resources. Study quality was assessed using Joanna Briggs Institution (JBI). RevMan 5.3 software was used to perform the meta-analysis. Result Fifteen randomized controlled trial studies met the criteria. Analysis of the subgroup before COVID-19 showed that PA had a significant effect on HRQOL, as measured by MLHFQ (SDM: −0.27, 95% CI: −0.47 to −0.07, n=590), KCCQ (SDM: 2.10, 95% CI: 0.74 to 3.46, n=53), 6MWT (SMD: 1.63, 95% CI: 0.80 to 2.46, n=284), and VO2 peak (SMD: 0.97, 95% CI: 0.00 to 1.93, n=106). Analysis of the subgroup during COVID-19 showed that PA resulted in a significant effect on HRQOL, MLHFQ (SDM: −0.62, 95% CI: −1.32 to 0.09, n=221), KCCQ (SDM: 0.33, 95% CI: 0.15 to 0.50, n=486), 6MWT (SMD: 0.47, 95% CI: 0.22 to 0.73, n=493), and VO2 peak (SMD: 0.35, 95% CI: 0.10 to 0.60, n=325). Conclusion The PA could increase HRQOL, 6MWT, and VO2 peak before and during COVID-19, and therefore should be considered as part of daily activities for patients with HF (AU)


Objetivo Comparar los efectos de la actividad física en la mejora de la calidad de vida relacionada con la salud (CVRS), el 6MWT y el pico de VO2 antes y durante la COVID-19 en pacientes con insuficiencia cardíaca. Métodos Siguiendo las pautas PRISMA, buscamos artículos relevantes en 5 bases de datos, incluidas Embase, MEDLINE, CINAHL, PEDro y Cochrane, así como recursos adicionales. Para evaluar la calidad del estudio se utilizó el Instituto Joanna Briggs, y el software RevMan 5.3 para realizar el metanálisis. Resultado Quince artículos de ensayos controlados aleatorizados cumplieron con los criterios. El análisis del subgrupo antes de la COVID-19 mostró que la actividad física tuvo un efecto significativo en la CVRS, según lo medido por el MLHFQ (DE: −0,27, IC 95%: −0,47 a −0,07, n=590), el KCCQ (DE: 2,10, IC 95%: 0,74 a 3,46, n=53), el 6MWT (DE: 1,63, IC 95%: 0,80 a 2,46, n=284) y el pico de VO2 (DE: 0,97, IC 95%: 0,00 a 1,93, n=106). El análisis del subgrupo durante la COVID-19 mostró que la actividad física tuvo un efecto significativo en la CVRS, el MLHFQ (DE: −0,66, IC 95%: −1,32 a 0,09, n=221), el KCCQ (DE: 0,33, IC 95%: 0,15 a 0,50, n=486), el 6MWT (DE: 0,47, IC 95%: 0,22 a 0,73, n=493) y el pico de VO2 (DE: 0,35, IC 95%: 0,10 a 0,60, n=325). Conclusión La actividad física podría aumentar la CVRS, el 6MWT y el pico de VO2 antes y durante la COVID-19, por lo que debe ser considerada como parte de las actividades diarias de los pacientes con insuficiencia cardíaca (AU)


Assuntos
Humanos , Insuficiência Cardíaca/reabilitação , Pico do Fluxo Expiratório/fisiologia , Qualidade de Vida , Exercício Físico
19.
S Afr J Physiother ; 79(1): 1841, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37928651

RESUMO

Background: Respiratory impairments refer to a reduction in pulmonary function, which may adversely affect an individual's health. Incentive spirometry is a technique designed to assist patients in achieving a pre-set airflow volume; the volume is determined from predicted values or baseline measurements. Our study aims to assess the effect of incentive spirometry on respiratory impairments. Method: Fifty-four patients aged 40 years and above with obstructive, restrictive or mixed respiratory impairments attending the respiratory clinic at the Lagos State University Teaching Hospital, Ikeja (LASUTH), will be recruited and assigned to three groups of 18 participants based on the class of respiratory impairment. Participants in each category of respiratory impairment will be subdivided into three groups. A final group of six participants per class of impairment will participate in the experiment. Our study will be a double-blind, randomised control trial with two intervention groups and one parallel placebo control group. Pulmonary function will be assessed before and after every procedure while the six-minute walk test (6MWT), Medical Research Council dyspnoea scale and the Pulmonary Functional Status and Dyspnea Questionnaire-Modified will be assessed fortnightly during our study. Data will be analysed using descriptive and inferential statistics and a repeated MANOVA; p < 0.05. Discussion: The outcome of our study may reveal the effect of inspiratory and expiratory incentive spirometry on obstructive, restrictive or mixed respiratory impairments. Conclusion: Our study may contribute to the body of knowledge on pulmonary rehabilitation. Clinical implication: Our study results may indicate if inspiratory incentive spirometry or expiratory incentive spirometry is better suited for the treatment of the respiratory impairment. Trial Registration: www.pactr.org: PACTR202005904039357.

20.
Int J Chron Obstruct Pulmon Dis ; 18: 2543-2553, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38022833

RESUMO

Background and Methods: Constant-minute-volume and constant-bolus devices serve as two different means of portable oxygen conservation. A prospective randomised crossover study was conducted in COPD GOLD IV patients to investigate the effect of these two devices on dyspnea, oxygenation and 6-minute walking test (6MWT) distance. The primary endpoint was the final operating level required (operating level range 1-5 for both devices) by either device to meet the success criteria for mobile oxygen therapy, as outlined in the British Thoracic Society guidelines (SpO2 ≥90% throughout 6MWT; ≥10% increase in walking distance from baseline; improvement in BORG of at least 1 point from baseline). Results: Twenty-five patients were enrolled in the study and randomly assigned to one of two sequences involving the use of each type of portable oxygen conservation device. 14 female, 67.9 years (±7.8); FEV1: 27.3%pred. (±8.4); PaO2 at rest without oxygen: 50.3mmHg (±5.9). For both systems, 24/25 patients (96%) were successfully recruited. The mean operating-level difference when success criteria were met was -0.58 in favor of the constant bolus device (95% CI: -0.88 to -0.28, P <0.001). Secondary endpoints (walking distance, respiratory rate and BORG dyspnea) showed no statistically significant or clinically relevant differences. An algorithm created especially for this study showed a high success rate in terms of titration for the required operating level. Conclusion: Both portable oxygen-conserving devices met the success criteria in 96% of patients in the 6MWT when they were titrated to the correct level. The constant-bolus device required a significantly lower operating level to achieve the success criteria, hereby reducing energy consumption. Individual titration of the respective device is recommended, which can be facilitated by the novel titration algorithm described here.


Assuntos
Doença Pulmonar Obstrutiva Crônica , Humanos , Feminino , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/terapia , Estudos Cross-Over , Estudos Prospectivos , Oxigênio , Dispneia/diagnóstico , Dispneia/terapia , Caminhada
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