Measurement properties of performance-based measures to assess physical function in chronic kidney disease: recommendations from a COSMIN systematic review.

Background: There is wide heterogeneity in physical function tests available for clinical and research use, hindering our ability to synthesize evidence. The aim of this review was to identify and evaluate physical function measures that could be recommended for standardized use in chronic kidney disease (CKD). Methods: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, CINAHL, Scopus and Web of Science were searched from inception to March 2022, identifying studies that evaluated a clinimetric property (validity, reliability, measurement error and/or responsiveness) of an objectively measured performance-based physical function outcomes using the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) methodology and Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) based recommendations. Studies with individuals of all ages and of any stage of CKD were included. Results: In total, 50 studies with 21 315 participants were included. Clinimetric properties were reported for 22 different physical function tests. The short physical performance battery (SPPB), Timed-up-and-go (TUG) test and Sit-to-stand tests (STS-5 and STS-60) had favorable properties to support their use in CKD and should be integrated into routine use. However, the majority of studies were conducted in the hemodialysis population, and very few provided information regarding validity or reliability. Conclusion: The SPPB demonstrated the highest quality of evidence for reliability, measurement error and construct validity amongst transplant, CKD and dialysis patients. This review is an important step towards standardizing a core outcome set of tools to measure physical function in research and clinical settings for the CKD population.

Results From a Physical Activity Intervention Feasibility Study With Kidney Inpatients.

BACKGROUND: Individuals with end-stage kidney disease requiring dialysis are often physically inactive, resulting in reduced physical functioning, increased frailty, and reduced quality of life. Furthermore, extended hospital stays and frequent readmissions are common, exacerbating health care costs. Physical activity may improve physical functioning, disability, and frailty but is not part of standard care of patients requiring dialysis. Research is required to determine the feasibility of implementing physical function assessments and physical activity programs in kidney inpatients requiring dialysis. OBJECTIVE: To assess the feasibility and preliminary efficacy of an early-physical activity intervention (Move More study) in the care of kidney inpatients requiring dialysis. It was hypothesized that the intervention would be feasible with regards to administration and participation, meeting a priori feasibility criteria, and that kidney inpatients would benefit from participating. DESIGN: Pilot study. SETTING: Patient Unit 37, Foothills Medical Center, Calgary, AB, Canada. PATIENTS: Kidney in-patients receiving dialysis. MEASUREMENTS: Feasibility data were collected for recruitment, participation, assessment completion, physical activity completion, and adverse events. Participant and healthcare practitioner (HCP) satisfaction with the intervention was assessed using a questionnaire. Frailty and physical function were assessed by the kinesiologist at baseline and postintervention prior to hospital discharge. METHODS: The study was a single-arm pilot intervention examining feasibility and preliminary efficacy. Kidney inpatients requiring dialysis were recruited to an individualized in-hospital physical activity intervention for the duration of their hospital stay. The intervention was led by a kinesiologist and supported by the clinical care team, including physiotherapists and nurse clinicians. Individualized exercise programs were created for patients to perform daily during their stay. These programs focused on strength, mobility, balance, and general movement and were tailored to each patient's needs. RESULTS: Thirty-six percent of eligible patients (n = 23/64) consented to participate in the Move More study, of whom 78% (n = 18/23) completed the intervention. The a priori level for consent to participate in the intervention was set at 60%. In addition, the a priori level for completion of assessments pre and postintervention was 50%. Ninety-five percent (n = 22/23) of preintervention assessments were completed compared to 65% of postintervention assessments. All participants who completed the survey (100%, n = 14/14) and most of the staff (77%, n = 24/31) reported being satisfied or very satisfied with the program. There were no adverse events related to the intervention. On average, Move More patients demonstrated improvements in frailty status and specific subsets of quality of life. LIMITATIONS: Firstly, as a feasibility study, the research was not powered to address the effectiveness of the intervention and lacked a comparison group to definitively link observed changes to the intervention itself. The voluntary nature of recruitment may have been biased toward ESKD inpatients with above-average motivation and baseline function. Furthermore, the small sample size from a single site limits the generalizability of findings. An additional limitation was the fact that postassessments were missed on a large number of patients, due to them being discharged prior to research staff knowing and being able to complete the assessments. Finally, studying the length of stay across the institution, as opposed to just the individual ward, would provide insight into hospitalization impact for these patients. CONCLUSIONS: The administration of and participation in a physical activity intervention for kidney inpatients requiring dialysis was initially not feasible primarily due to low recruitment and adherence challenges. The study was modified by including a research team member on the unit to increase recruitment efforts and support exercise adherence. The intervention impact includes potentially benefits on frailty and quality of life.

CONTEXTE: Les personnes atteintes d'insuffisance rénale terminale (IRT) nécessitant une dialyze sont souvent inactives physiquement, ce qui entraîne une réduction du fonctionnement physique, une fragilité accrue et une diminution de la qualité de vie. De plus, les séjours prolongés à l'hôpital et les réadmissions fréquentes sont courants chez ces patients, ce qui accroît les coûts des soins de santé. L'activité physique peut améliorer le fonctionnement physique et réduire les incapacités et la fragilité, mais elle ne fait pas partie des soins courants prodigués aux patients nécessitant une dialyze. Des recherches sont nécessaires pour déterminer la faisabilité de la mise en œuvre d'évaluations du fonctionnement physique et de programs d'activité physique chez les patients hospitalisés atteints de néphropathie nécessitant une dialyze. OBJECTIFS: Évaluer la faisabilité et l'efficacité préliminaire d'une intervention précoce en matière d'activité physique (l'étude Move More) intégrée aux soins prodigués aux patients hospitalisés atteints d'insuffisance rénale et nécessitant une dialyze. L'hypothèse était que l'intervention serait réalisable en ce qui concerne l'administration et la participation, qu'elle répondrait aux critères de faisabilité a priori, et que les patients hospitalisés bénéficieraient d'une participation. TYPE D'ÉTUDE: Étude pilote. CADRE: L'unité de soins 37 du Foothills Medical Center de Calgary (Alberta) au Canada. SUJETS: Des patients hospitalisés recevant des traitements de dialyze. MESURES: Les données de faisabilité ont été recueillies pour le recrutement, la participation, l'achèvement de l'évaluation, l'achèvement du program d'activité physique et les événements indésirables. La satisfaction des participants et des professionnels de la santé à l'égard de l'intervention a été évaluée à l'aide d'un questionnaire. La fragilité et les fonctions physiques ont été évaluées avant et après l'intervention, et avant la sortie de l'hôpital. MÉTHODOLOGIE: L'étude était une intervention pilote à bras unique examinant la faisabilité et l'efficacité préliminaire. Les patients hospitalisés atteints d'insuffisance rénale et nécessitant une dialyze ont été recrutés pour une intervention individualisée d'activité physique pendant toute la durée de leur séjour à l'hôpital. L'intervention était dirigée par un kinésiologue et appuyée par l'équipe de soins cliniques qui comprenait notamment des physiothérapeutes et des infirmières cliniciennes. Des programs d'activité physique individualisés ont été créés afin que les patients puissent s'exercer quotidiennement pendant leur séjour. Ces programs étaient axés sur la force, la mobilité, l'équilibre et le mouvement général, et étaient adaptés aux besoins de chaque patient. RÉSULTATS: Trente-six pour cent des patients admissibles (n=23/64) ont consenti à participer à l'étude Move More; de ceux-ci, 78 % (n=18/23) ont complété l'intervention. Le niveau a priori de consentement à participer à l'intervention a été fixé à 60 % et celui de l'achèvement des évaluations avant et après l'intervention à 50 %. Quatre-vingt-quinze pour cent (n=22/23) des évaluations pré-intervention ont été effectuées, comparativement à 65 % pour les évaluations postintervention. Tous les participants qui ont répondu au sondage (100 %; n=14/14) et la majorité du personnel (77 %; n=24/31) interrogé ont déclaré être satisfaits ou très satisfaits du program. Aucun événement indésirable lié à l'intervention n'a été signalé. En moyenne, les patients de Move More ont montré des améliorations de leur état de fragilité et de sous-ensembles propres à la qualité de vie. LIMITES: Puisqu'il s'agit d'une étude de faisabilité, la recherche n'avait pas la puissance nécessaire pour évaluer l'efficacité de l'intervention et ne disposait pas de groupe de comparaison permettant d'établir un lien définitif entre les changements observés et l'intervention elle-même. La nature volontaire du recrutement pourrait avoir favorisé les patients hospitalisés atteints d'IRT ayant une motivation et une fonction de base supérieures à la moyenne. L'échantillon de petite taille, provenant d'un seul site, limite la généralisabilité des résultats. De plus, les évaluations postintervention ont été manquées pour un grand nombre de patients, ceux-ci ayant obtenu leur congé avant que le personnel de recherche ait été avisé ou en mesure de compléter les évaluations. Enfin, le fait de connaître la durée du séjour dans l'ensemble de l'établissement, et non seulement dans chaque service permettrait de mieux comprendre l'impact de l'hospitalization pour ces patients. CONCLUSION: L'exécution d'une intervention d'activité physique et la participation des patients hospitalisés nécessitant une dialyze à une telle intervention n'étaient pas réalisables initialement, principalement en raison de difficultés liées au recrutement et à l'observance. L'étude a été modifiée pour intégrer un membre de l'équipe de recherche dans l'unité de soins afin d'accroître les efforts de recrutement et de soutenir l'observance du program d'exercices. L'impact de l'intervention comprend des avantages potentiels sur la fragilité et la qualité de vie.

Effects of a 12-week HIIT + group mediated cognitive behavioural intervention on quality of life among inactive adults with coeliac disease: findings from the pilot MOVE-C study.

OBJECTIVE: The purpose of the pilot MOVE-C study was to examine the effects of a 12-week high-intensity interval training (HIIT) plus lifestyle education program on quality of life (QoL), behavioural and psychosocial outcomes among inactive adults with coeliac disease. DESIGN: This study used a 3 (time: baseline, immediately post and three months post) × 2 (group: experimental versus waitlist control) mixed design. After completing baseline testing, 41 participants were randomised to one of two groups: HIIT + or waitlist control (WLC). The HIIT + intervention involved twice-weekly HIIT, during which participants progressed to 14 × 30 s intervals (90% heart rate max; HRmax), with 2-minute recovery (50% HRmax). The HIIT + intervention also included six bi-weekly education sessions. RESULTS: Participants in HIIT + reported significant improvements in QoL and exercise behaviour immediately post-intervention, and this was sustained three months post-intervention, whereas no changes in QoL nor exercise behaviour were reported in WLC. Improvements were also reported among HIIT + immediately after the intervention for gastrointestinal symptoms and self-compassion. All participants reported significant improvements in adherence to a GFD immediately post-intervention. CONCLUSION: Findings from this pilot study provide preliminary evidence that a tailored exercise and lifestyle intervention can lead to improved QoL, exercise behaviour, gastrointestinal symptoms and self-compassion among inactive adults with coeliac disease.

A Physical Activity Intervention Feasibility Study for Kidney Inpatients: A Basic Research Protocol.

BACKGROUND: Low physical activity levels and poor physical functioning are strongly associated with poor clinical outcomes and mortality in adult kidney failure patients, regardless of treatment modality. Compared with the general population, individuals with chronic kidney disease are physically inactive, have reduced physical abilities and difficulties performing routine daily tasks, lower health-related quality of life, and higher cardiovascular morbidity and mortality. In addition, frail kidney failure patients have higher hospitalization and mortality rates as compared with other kidney failure patients. Evidence suggests that assessment and recommendations for physical activity should be part of standard care for kidney failure patients. Structured exercise can improve physical function and quality of life in frail older adults and may be used specifically for management of frailty in kidney failure. However, research is needed to determine best practices for implementation of physical function measurements and physical activity promotion in standard kidney failure care. OBJECTIVE: The proposed Move More study will assess the feasibility of a physical activity intervention offered to the kidney failure inpatients in Calgary, Alberta. Specifically, this study is designed to examine the effects of an early physical activity/mobility intervention led by a kinesiologist, and supported by the clinical care team including physiotherapists (PT) and nurse clinicians. METHODS: The Move More study is a single-arm pilot intervention examining feasibility and optimal improvement in real-world conditions. Kidney failure inpatients at the Foothills Medical Centre will be recruited to participate. Patients will receive an individualized in-hospital physical activity/mobility intervention. Frailty and physical function will be assessed at baseline and postintervention prior to hospital discharge. The goal is to recruit 24 to 36 patients. CONCLUSIONS: Evidence needed to support the inclusion of mobility and physical activity as part of standard care will be gathered, with knowledge gained used to help direct future physical activity programming for kidney failure inpatients.

CONTEXTE: Un faible niveau d'activité physique et une santé physique hypothéquée sont fortement associés à de mauvais résultats cliniques et à la mortalité chez les adultes atteints d'insuffisance rénale terminale (IRT), quelle que soit la modalité de traitement. Comparativement à la population générale, les personnes atteintes d'IRT sont moins actives, ont des capacités physiques réduites, ont davantage de difficulté à accomplir leurs tâches quotidiennes, ont une plus faible qualité de vie liée à la santé, et présentent des taux plus élevés de morbidité et de mortalité associées aux maladies cardiovasculaires. Par ailleurs, les patients physiquement fragiles qui souffrent d'IRT présentent des taux d'hospitalisation et de mortalité plus élevés que les autres patients atteints d'IRT. Les données indiquent qu'une évaluation des fonctions physiques et des recommandations en matière d'activité physique devraient faire partie des soins courants prodigués aux patients souffrant d'IRT. Un programme d'exercice structuré est susceptible d'améliorer la santé physique et la qualité de vie des personnes âgées fragiles, et pourrait être utilisé précisément pour gérer la fragilité en contexte d'IRT. Des recherches sont cependant nécessaires pour cerner les meilleures pratiques à adopter pour mettre en œuvre des mesures évaluant la fonction physique et faire la promotion de l'activité physique dans le cadre des soins courants prodigués en contexte d'IRT. OBJECTIFS: L'étude Move More proposée évaluera la faisabilité d'une intervention favorisant l'activité physique qui sera offerte aux patients hospitalisés souffrant d'IRT à Calgary, en Alberta. Plus précisément, cette étude est conçue pour examiner les effets d'une intervention précoce en matière d'activité physique et de mobilité, dirigée par un kinésiologue et appuyée par une équipe de soins cliniques composée de physiothérapeutes (PT) et d'infirmières cliniciennes. MÉTHODOLOGIE: L'étude Move More est une intervention pilote à bras unique qui examinera la faisabilité et l'amélioration optimale en conditions réelles. Les patients avec IRT au centre médical Foothills seront recrutés pour participer à l'étude. Les patients bénéficieront d'un programme individualisé d'activité physique/mobilité à l'hôpital. La fragilité et les fonctions physiques seront évaluées avant et après l'intervention, avant la sortie de l'hôpital. L'objectif est de recruter entre 24 et 36 patients. CONCLUSIONS: Les preuves nécessaires pour appuyer l'inclusion d'une intervention visant la mobilité et l'activité physique aux soins courants seront rassemblées. Les connaissances acquises serviront à orienter de futurs programmes d'activité physique destinés aux patients hospitalisés souffrant d'IRT.

Feasibility and effects on the gut microbiota of a 12-week high-intensity interval training plus lifestyle education intervention on inactive adults with celiac disease.

This study assessed the feasibility and benefits of high-intensity interval training (HIIT) plus lifestyle education among inactive adults with celiac disease. Forty-one participants were randomized to receive the intervention (HIIT plus lifestyle education; HIIT+) for 12 weeks or waitlist control (WLC). Testing was completed at baseline, immediately post-intervention, and 3 months post-intervention. Generalized estimating equations were used to assess changes in the outcome variables over time between the groups. Mean percent of age-predicted maximum heart rate was 97.9% and average rating of perceived exertion was 6.33 (out of 10) during HIIT intervals. Following the intervention, the HIIT+ showed enrichment in relative abundance of Parabacteroides and Defluviitaleaceae_UCG_011 while WLC showed enrichment in relative abundance of Roseburia intestinalis, Klebsiella, and Adlercreutzia. A unique set of taxa were differentially abundant between the groups at 3 months post-intervention. HIIT+ participants experienced a reduction in resting heart rate (-6.6 bpm) immediately post-intervention compared with WLC. Further research is needed to establish an optimal HIIT protocol that may improve maximal oxygen uptake and metabolic syndrome biomarkers. Findings from this pilot study provide preliminary evidence that an HIIT intervention is feasible for inactive adults with celiac disease and leads to favourable changes in resting heart rate alongside potentially beneficial shifts in gut microbiota. Trial registration number: ClinicalTrials.gov number NCT03520244. Novelty: HIIT leads to potentially beneficial changes in the gut microbiota of adults with celiac disease. An HIIT exercise intervention is feasible and well tolerated for patients with celiac disease.

A 12-Week Pilot Exercise Program for Inactive Adults With Celiac Disease: Study Protocol.

BACKGROUND: Individuals with celiac disease must follow a strict gluten-free diet (GFD) in order to avoid negative short- and long-term health consequences. Unfortunately, many people with celiac disease report poor quality of life (QoL) despite following a strict GFD, and up to 30% still report negative symptoms (eg, gastrointestinal upset). PURPOSE: The purpose of the MOVE-C (understanding the relationship between the MicrobiOme, Vitality, and Exercise in Celiac disease) pilot study is to explore the effects of a 12-week supervised progressive high-intensity interval training (HIIT) and lifestyle intervention on physiological, behavioral, and psychosocial outcomes among inactive adults with celiac disease.Methods/Design: Sixty inactive adults diagnosed with celiac disease will be randomized to HIIT+ or waitlist control (WLC). Participants in the HIIT+ will engage in a 12-week HIIT + lifestyle education program. HIIT sessions will be comprised of 2 workouts per week, working up to 14 × 30-second intervals at 90% maximal heart rate (HRmax) followed by 2 minutes recovery at 50% HRmax. The 6 biweekly lifestyle sessions will involve education on the promotion of a whole foods GFD, sleep hygiene, psychosocial coping skills (eg, self-compassion), and self-regulatory skills to master changes in behaviors. Assessments will occur at pre and post 12-week intervention and 3-month follow-up. WLC participants will be offered a 12-week HIIT program + online lifestyle education sessions after completing the final assessment. The primary outcomes are QoL and gut microbiota composition assessed with 16S rRNA sequencing. The secondary outcomes are markers of metabolic syndrome (waist circumference, fasting glucose, serum lipids, blood pressure, and body composition), gastrointestinal symptoms, sleep quality, adherence to a GFD, exercise behavior, self-regulatory efficacy, and self-compassion. It is hypothesized that participants in the HIIT+ will experience improvements in all outcomes when compared to those in the WLC. These improvements are expected to be maintained at the 3-month follow-up. DISCUSSION: The findings from this study will advance the knowledge regarding the effects of HIIT and lifestyle education on key outcomes for an at-risk chronic disease population. Furthermore, the findings can be used to inform future programs to improve fitness and physical and mental health outcomes for people with celiac disease.

The Effects of Exercise on Physical and Psychological Outcomes in Cancer Caregivers: Results From the RECHARGE Randomized Controlled Trial.

Background: Family caregivers to cancer patients are at risk for physical and psychological morbidity as a direct result of being in the caregiver role. Exercise as an intervention to support caregiver health and well-being has been tested in other caregiver populations; however, no randomized controlled trials testing the effects of an aerobic and resistance training program have been conducted where cancer caregivers only have participated. Purpose: To examine the effects of a 12-week exercise program on quality of life (Short Form 36 v2), psychological outcomes, physical activity levels, and physical fitness in caregivers to cancer patients. Methods: Seventy-seven caregivers were randomized to either an exercise intervention or wait-list control. Two participants in the exercise arm dropped out immediately after their baseline assessment. Outcome data for n = 77 participants were analyzed using intention-to-treat analysis with linear mixed models. Results: Significant group by time interaction effects were detected for exercise on the mental health component score of quality of life, self-reported weekly exercise levels, and the six-minute walk test. Small to medium effect sizes were detected on several outcomes including physical health component of quality of life (d = 0.36), mental health component of quality of life (d = 0.74), depression (d = 0.41), anxiety (d = 0.35), physical activity levels (d = 0.80), and the six-minute walk test (d = 0.21). Conclusions: The findings suggest that exercise may improve health and well-being and could be considered as an additional type of support offered to cancer caregivers. Clinical trial registration no: NCT02580461.