ABSTRACT
BACKGROUND: Dyspnea is a prevalent symptom in individuals with hypermobile Ehlers-Danlos Syndrome (hEDS) and generalized hypermobility spectrum disorder (G-HSD), yet its contributors have not been identified. One known contributor to dyspnea is respiratory muscle weakness. The feasibility and effectiveness of inspiratory muscle training (IMT) in combination with standard-of-care rehabilitation (aerobic, resistance, neuromuscular stabilization, and balance and proprioception exercises) in improving respiratory muscle strength and patient-reported outcomes in patients with hEDS or G-HSD have not been evaluated. OBJECTIVE: This study aims to evaluate dyspnea, respiratory muscle strength, and patient-reported outcome measures (PROMs) in hEDS or G-HSD compared with healthy controls and to assess the feasibility of a randomized controlled trial of IMT and standard-of-care rehabilitation for improving respiratory muscle strength, exercise capacity, and PROMs compared with standard-of-care rehabilitation in hEDS and G-HSD. METHODS: The study will include 34 participants with hEDS or G-HSD and 17 healthy, age- and sex-matched controls to compare respiratory muscle structure and function and PROMs. After baseline assessments, participants with hEDS or G-HSD will be randomized into the intervention group and provided IMT combined with Ehlers-Danlos Syndrome standard-of-care rehabilitation or into the usual care group, and provided only standard-of-care rehabilitation for 8 weeks. The intervention group will be prescribed IMT in their home environment using the POWERbreathe K5 IMT device (POWERbreathe International Ltd). IMT will comprise 2 daily sessions of 30 breaths for 5 days per week, with IMT progressing from 20% to 60% of the baseline maximal inspiratory pressure (MIP) over an 8-week period. Feasibility will be assessed through rates of recruitment, attrition, adherence, adverse events, and participant satisfaction. The primary pilot outcome is MIP change over an 8-week period in hEDS or G-HSD. Secondary outcomes will include the evaluation of dyspnea using Medical Research Council Scale and 18-point qualitative dyspnea descriptors; diaphragmatic thickening fraction using ultrasound; respiratory muscle endurance; pulmonary function; prefrontal cortical activity using functional near-infrared spectroscopy; aerobic capacity during cardiopulmonary exercise testing; quality of life using Short Form-36; and scores from the Depression, Anxiety, and Stress scale-21. These measures will also be performed once in healthy controls to compare normative values. Multivariable regression will be used to assess the contributors to dyspnea. Paired 2-tailed t tests will be used to assess the changes in MIP and secondary measures after 8 weeks of IMT. RESULTS: Study recruitment began in August 2021 and, with several disruptions owing to COVID-19, is expected to be completed by December 2023. CONCLUSIONS: This study will provide a better understanding of the factors associated with dyspnea and the feasibility and effectiveness of IMT combined with standard-of-care rehabilitation. IMT may be a novel therapeutic strategy for improving respiratory muscle function and patient-reported outcomes in individuals with hEDS or G-HSD. TRIAL REGISTRATION: ClinicalTrials.gov NCT04972565; https://clinicaltrials.gov/ct2/show/NCT04972565. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44832.
ABSTRACT
BACKGROUND: Exercise and relaxation interventions have demonstrated benefits in allogeneic hematopoietic stem cell transplant (allo-HSCT) patients; however, little is known about the implementation enablers and barriers for inpatient rehabilitation or its impact on health outcomes. OBJECTIVE: To conduct a program evaluation of group-based rehabilitation consisting of exercise and relaxation classes for allo-HSCT inpatients. DESIGN: Prospective program evaluation using the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. SETTING: Inpatient hospital unit at a tertiary care center. PARTICIPANTS: Forty-five adult patients admitted for allo-HSCT. INTERVENTIONS: Standard of care rehabilitation. MAIN OUTCOME MEASURES: Program attendance, safety, satisfaction, and fidelity were assessed. Exploratory effectiveness analyses were conducted via the measurement of physical, psychosocial, clinical, and health resource use outcomes at hospital admission and discharge. RESULTS: Forty-seven of the 63 patients receiving allo-HSCT between November 2019 and March 2020 were consented. Data presented in this publication are from the 33 participants who completed study assessments (high attrition due to cancellation of research during the COVID-19 pandemic). Eighty-two percent of participants attended at least one class; however, 55% of the participants invited to the classes on a daily basis were not able to attend. Barriers to participation included transplant complications, isolation for infection prevention, and fatigue. There were no adverse events associated with the intervention and 82% of participants adhered to the prescribed activities. Participants reported satisfaction with the program and enjoyed the motivational support and social interaction. Between hospital admission and discharge, anxiety scores improved; however, fatigue, depression, grip strength, functional mobility, and quality of life scores declined. Physical activity volume and lower body strength were maintained. CONCLUSIONS: Group-based exercise and relaxation classes seem to be feasible and safe during hospitalization for allo-HSCT; however, there are pragmatic barriers to be considered for optimal program implementation. Further research examining program effectiveness and adoption is warranted.
ABSTRACT
Purpose of Review: Multimodal prehabilitation aims to improve preoperative health in ways that reduce surgical complications and expedite post-operative recovery. However, the extent to which preoperative health has been affected by the COVID-19 pandemic is unclear and evidence for the mitigating effects of prehabilitation in this context has not been elucidated. The COVID-19 pandemic has forced a rapid reorganization of perioperative pathways. Delayed diagnosis and surgery have caused a backlog of cases awaiting surgery increasing the risk of more complex procedures due to disease progression. Poor fitness and preoperative deconditioning are predictive of surgical complications and may be compounded by pandemic-related restrictions to accessing supportive services. The COVID-19 pandemic has forced a rapid reorganization of perioperative pathways. This narrative review aims to summarize the understanding of the effects of the COVID-19 pandemic on preoperative health and related behaviors and their implication for the need and delivery for prehabilitation to engender improved surgical outcomes. A literature search of Medline was conducted for articles related to preoperative health, prehabilitation, and surgical outcomes published between December 1, 2020 and January 31, 2021. Additional hand searches for relevant publications within the included literature were also conducted through October 15, 2021. Recent Findings: The COVID-19 pandemic, and measures designed to reduce the spread of the virus, have resulted in physical deconditioning, deleterious dietary changes, substance misuse, and heightened anxiety prior to surgery. Due to the adverse health changes prior to surgery, and often protracted waiting time for surgery, there is likely an elevated risk of peri- and post-operative complications. A small number of prehabilitation services and research programmes have been rapidly adapted or implemented to address these needs. Summary: During the COVID-19 pandemic to date, people undergoing surgery have faced a triple threat posed by extended wait times for surgery, reduced access to supportive services, and an elevated risk of poor outcomes. It is imperative that healthcare providers find ways to employ evidence-based prehabilitation strategies that are accessible and safe to mitigate the negative impact of the pandemic on surgical outcomes. Attention should be paid to cohorts most affected by established health inequities and further exacerbated by the pandemic.
ABSTRACT
BACKGROUND: Posttransplant metabolic syndrome (PTMS) is a common contributor to morbidity and mortality among solid organ transplant recipients in the late posttransplant period (≥1 year). Patients diagnosed with PTMS are at a higher risk of cardiovascular disease and frequently experience decreased physical function and health-related quality of life (HRQL). Studies in the early posttransplant period (<1 year) have shown the benefits of facility-based exercise training on physical function and HRQL, but have not evaluated the effects on metabolic risk factors. It remains unclear whether home-based exercise programs are feasible and can be delivered at a sufficient exercise dose to have effects on PTMS. This protocol outlines the methodology of a randomized controlled trial of a partly supervised home-based exercise program in lung transplant (LTx) and orthotopic liver transplant (OLT) recipients. OBJECTIVE: This study aims to evaluate the feasibility (ie, recruitment rate, program adherence, attrition, safety, and participant satisfaction) of a 12-week individualized, home-based aerobic and resistance training program in LTx and OLT recipients initiated 12 to 18 months after transplantation, and to assess estimates of intervention efficacy on metabolic risk factors, exercise self-efficacy, and HRQL. METHODS: In total, 20 LTx and 20 OLT recipients with ≥2 cardiometabolic risk factors at 12 to 18 months after transplantation will be randomized to an intervention (home-based exercise training) or control group. The intervention group will receive an individualized exercise prescription comprising aerobic and resistance training, 3 to 5 times a week for 12 weeks. Participants will meet on a weekly basis (via videoconference) with a qualified exercise professional who will supervise exercise progression, provide support, and support exercise self-efficacy. Participants in both study groups will receive a counseling session on healthy eating with a dietitian at the beginning of the intervention. For the primary aim, feasibility will be assessed through recruitment rate, program adherence, satisfaction, attrition, and safety parameters. Secondary outcomes will be measured at baseline and 12 weeks, including assessments of metabolic risk factors (ie, insulin resistance, abdominal obesity, blood pressure, and cholesterol), HRQL, and exercise self-efficacy. Descriptive statistics will be used to summarize program feasibility and effect estimates (means and 95% CIs) for sample size calculations in future trials. RESULTS: Enrollment started in July 2021. It is estimated that the study period will be 18 months, with data collection to be completed by December 2022. CONCLUSIONS: A partly supervised home-based, individually tailored exercise program that promotes aerobic and resistance training and exercise self-efficacy may be an important intervention for improving the metabolic profile of LTx and OLT recipients with cardiometabolic risk factors. Thus, characterizing the feasibility and effect estimates of home-based exercise constitutes the first step in developing future clinical trials designed to reduce the high morbidity associated with PTMS. TRIAL REGISTRATION: ClinicalTrials.gov NCT04965142; https://clinicaltrials.gov/ct2/show/NCT04965142. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35700.
ABSTRACT
BACKGROUND: Experimental data highlight the potential benefits and health system cost savings related to surgical prehabilitation; however, adequately powered randomized controlled trial (RCT) data remain nascent. Emerging prehabilitation services may be informed by early RCT data but can be limited in informing real-world program development. Pragmatic trials emphasize external validity and generalizability to understand and advise intervention development and implementation in clinical settings. This paper presents the methodology of a pragmatic prehabilitation trial to complement emerging phase III clinical trials and inform implementation strategies. METHODS: This is a pilot pragmatic clinical trial conducted in a large academic hospital in Toronto, Ontario, Canada to assess feasibility of clinical implementation and derive estimates of effectiveness. Feasibility data include program referral rates, enrolment and attrition, intervention adherence and safety, participant satisfaction, and barriers and facilitators to programming. The study aims to receive 150 eligible referrals for adult, English-speaking, preoperative oncology patients with an identified indication for prehabilitation (e.g., frailty, deconditioning, malnutrition, psychological distress). Study participants undergo a baseline assessment and shared-decision making regarding the intervention setting: either facility-based prehabilitation or home-based prehabilitation. In both scenarios, participants receive an individualized exercise prescription, stress-reduction psychological support, nutrition counseling, and protein supplementation, and if appropriate, smoking cessation program referrals. Secondary objectives include estimating intervention effects at the week prior to surgery and 30 and 90 days postoperatively. Outcomes include surgical complications, postoperative length of stay, mortality, hospital readmissions, physical fitness, psychological well-being, and quality of life. Data from participants who decline the intervention but consent for research-related access to health records will serve as comparators. The COVID-19 pandemic required the introduction of a 'virtual program' using only telephone or internet-based communication for screening, assessments, or intervention was introduced. CONCLUSION: This pragmatic trial will provide evidence on the feasibility and viability of prehabilitation services delivered under usual clinical conditions. Study amendments due to the COVID-19 pandemic are presented as strategies to maintain prehabilitation research and services to potentially mitigate the consequences of extended surgery wait times.