"Move More" Exercise Program for Hemodialysis Patients (Move More Trial)
Recruiting in Palo Alto (17 mi)
Overseen ByKenneth R Wilud, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Arizona
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to compare the efficacy of a standard intradialytic exercise program (control group) to an individualized, patient-centered, "Move-More" physical activity intervention (intervention group) in hemodialysis (HD) patients.
Exercise programs often fail to yield robust benefits for many HD patients, in part because the type and volume of exercise prescribed is inappropriate for a variety of reasons, and the benefits from these studies are often disappointing, as they are characterized by poor adherence, high dropout rates, and modest effects on physical function, body composition, cardiovascular disease risk, and other outcomes related to quality of life (QOL). To address this, the investigators have designed a novel physical activity intervention "Move More" that is designed to overcome many of the barriers to increasing physical activity in this population. This study aims to compare the efficacy of a standard intradialytic exercise program (control group) to an individualized, patient-centered, "Move-More" physical activity intervention (intervention group) in HD patients. The investigators primary hypothesis is that patients randomized to the Move More intervention will increase their physical activity levels more than those in the intradialytic exercise group.
The main question it aims to answer is:
• Does "Move More" increase the physical activity levels (minutes) measured through weekly minutes of physical activity and the LoPAQ questionnaire more than those in the standard intradialytic exercise program?
For secondary outcomes this study aims to answer the following:
* Does "Move More" improve the physical function of hemodialysis patients assessed by the short physical performance battery (SPBB) more than those in the standard intradialytic exercise program?
* Does "Move More" decrease fatigue assess by the SONG-HD survey more than those in the standard intradialytic exercise program?
* Does "Move More" decrease symptoms of depression assessed by PROMIS Depression Short Form 8a more than those in the standard intradialytic exercise program?
* Does "Move More" increase the amount of exercise measured through a point system more than those in the standard intradialytic exercise program?
* Does "Move More" improve blood pressure (BP) more than those in the standard intradialytic exercise program?
How is the 'Move More' exercise program different from other treatments for hemodialysis patients?
The 'Move More' exercise program is unique because it focuses on incorporating physical activity into the routine care of hemodialysis patients, aiming to improve their physical capabilities and quality of life. Unlike standard treatments that may not emphasize exercise, this program addresses the common sedentary lifestyle in these patients and seeks to enhance their overall well-being through regular physical activity.
12678Is the 'Move More' exercise program safe for hemodialysis patients?
Research on similar exercise programs for hemodialysis patients, like intradialysis yoga, suggests they are generally safe. However, specific safety data for the 'Move More' program itself is not detailed in the available studies.
345710What data supports the effectiveness of the treatment Move More for hemodialysis patients?
Research shows that exercise programs for hemodialysis patients can improve their physical function, strength, and quality of life. Studies have found that incorporating exercise, like cycling during dialysis, can help manage cardiovascular risk factors and enhance overall well-being.
6791112Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
Eligibility Criteria
This trial is for hemodialysis patients who are looking to improve their physical activity levels and overall quality of life. The study will compare a standard exercise program with a personalized 'Move More' program tailored to individual needs.Inclusion Criteria
I have been on hemodialysis for at least 3 months.
Participant Groups
The study tests if the 'Move More' personalized exercise program increases weekly physical activity more effectively than standard intradialytic exercises in hemodialysis patients, also measuring improvements in physical function, fatigue, depression symptoms, and blood pressure.
2Treatment groups
Experimental Treatment
Active Control
Group I: Move More Personalized Exercise ProgramExperimental Treatment1 Intervention
Personalized physical activity program aimed to increase the physical activity levels determined through a point system. Points are derived from metabolic equivalent (MET) scores and can be accumulated by performing any activity (e.g., "lifestyle" activities, aerobic, and/or resistance exercises) the participants complete. Weekly challenges/goals will be set to encourage participants to increase their physical activity levels. Participants will have the autonomy to decide about their weekly challenges or goals.
Group II: Intradialytic Exercise ProgramActive Control1 Intervention
Participation in an Intradialytic cycling (exercise during dialysis) physical activity prescription and resistance ("strength training") exercise for 6 months.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
DCI Desert DialysisTucson, AZ
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Who is running the clinical trial?
University of ArizonaLead Sponsor
References
Exercise program to enhance physical performance and quality of life of older hemodialysis patients: a feasibility study. [2022]Evaluate the feasibility of implementing a combined in-hospital and home-based exercise program in older hemodialysis (HD) patients.
Physical activity and exercise training: a relevant aspect of the dialysis patient's care. [2021]Sedentary lifestyle is frequent in hemodialysis patients whose physical capabilities are largely reduced when compared with healthy subjects, and evidence exists that sedentary dialysis patients are at higher risk of death as compared to non-sedentary ones. Dialysis patients may suffer from cardiovascular disease, diabetes, malnutrition, depression, which limits their exercise capacity; conversely, regular physical exercise may favor rehabilitation and correction of several cardiovascular, metabolic and nutritional abnormalities. Many observational, population-based studies show that the level of physical activity is related to quality of life and nutritional status, as well as to the survival probability. Intervention studies are instead lacking; a randomized controlled multicenter trial is in progress in Italy to assess the effect of home-based exercise programs on survival and hospitalization rate in stable dialysis patients. Implementation of physical activity should be one of the goals of dialysis care management, but several barriers prevent a widespread implementation of physical exercise programs in the dialysis units. A lack of patients' or care-givers' motivation or willingness, and structural or functional resources are the most frequent obstacles to exercise implementation. Since the hemodialysis population is quite heterogeneous for physical abilities and comorbidities, exercise in not for everyone and individual prescription is required for a correct and safe implementation of physical activity.
Feasibility and Safety of Intradialysis Yoga and Education in Maintenance Hemodialysis Patients. [2018]Patients with end-stage renal disease on maintenance hemodialysis are much more sedentary than healthy individuals. The purpose of this study was to assess the feasibility and safety of a 12-week intradialysis yoga intervention versus a kidney education intervention on the promotion of physical activity.
A structured exercise programme during haemodialysis for patients with chronic kidney disease: clinical benefit and long-term adherence. [2022]Long-term studies regarding the effect of a structured physical exercise programme (SPEP) during haemodialysis (HD) assessing compliance and clinical benefit are scarce.
Physical Activity Dose for Hemodialysis Patients: Where to Begin? Results from a Prospective Cohort Study. [2022]Greater physical activity is associated with lower risk of mortality in persons with kidney disease; however, little is known about the appropriate dose of physical activity among hemodialysis patients. Here detected the minimum level of habitual physical activity to help inform interventions aimed at improving outcomes in the dialysis population.
Intradialytic exercise training modalities on physical functioning and health-related quality of life in patients undergoing maintenance hemodialysis: systematic review and meta-analysis. [2019]To determine the effects of different intradialytic exercise training modalities on physical functioning and health-related quality of life of maintenance hemodialysis patients.
Effectiveness of an educational intervention and physical exercise on the functional capacity of patients on haemodialysis. [2021]To describe the impact of a standard hospital educational intervention including active physical exercises on personal well-being, functional capacity and knowledge of the benefits of prescribed physical activity for patients undergoing haemodialysis.
A cross-sectional study exploring levels of physical activity and motivators and barriers towards physical activity in haemodialysis patients to inform intervention development. [2021]To describe physical activity (PA) levels and motivators and barriers to PA amongst haemodialysis (HD) patients and to identify an appropriate approach to increasing their PA.
Exercise in patients on chronic hemodialysis: current evidence, knowledge gaps and future perspectives. [2021]Physical inactivity is common in hemodialysis patients, and is associated with disability and poor outcomes. We summarize the effects of aerobic, resistance or mixed exercise training on aerobic capacity, muscle mass and strength, dialysis efficiency, quality of life and cardiovascular adaptation according to clinical studies on this population, also focusing on knowledge gaps as topics for future research. Finally, we put evidence into clinical context deriving practical indications for exercise implementation in these patients.
Effect of Long-term Exercise Training on Physical Performance and Cardiorespiratory Function in Adults With CKD: A Randomized Controlled Trial. [2023]The safety and efficacy of long-term exercise training in reducing physical functional loss in older adults with advanced CKD and comorbidity is uncertain.
Exercise in Dialysis: Ready for Prime Time? [2022]It is widely acknowledged that patients with end-stage kidney disease receiving maintenance hemodialysis (HD) may benefit from increasing their physical activity levels. Decades of exercise-related clinical trials have demonstrated improvements in various metrics related to dialysis patient's health and quality of life. Yet, the implementation of exercise programs in dialysis clinics today is scarce, and physical inactivity and dysfunction remain a hallmark of the disease. To address this issue, many groups worldwide are beginning to rethink how physical activity and exercise are prescribed in HD patients, as well as how to evaluate the efficacy of these programs. The vast majority of exercise interventions in HD patients have included intradialytic cycling as the predominant or only exercise prescription. Moreover, efficacy has most often been evaluated using standard measures of strength, physical function, and/or traditional cardiovascular disease risk factors (e.g., blood pressure, lipids, etc.). More recently, there has been a greater emphasis on novel intervention approaches that are focused on providing patients with a greater variety of options for exercise and enhanced motivational tools. The benefits of exercise on patient reported outcome measures (PROMs) and other clinically important outcomes are also becoming more prevalent. The purpose of this review was to: (1) critically review the data from several recently published large randomized clinical trials of exercise in HD patients, (2) discuss some of the novel approaches that groups across the world are taking to improve implementation and efficacy of exercise-related interventions in HD, and (3) discuss policy prescriptions that may be needed to continue improving exercise prescriptions for this critically ill patient population. While it may be too early to declare that exercise in dialysis is ready for prime time, exciting advances have been made in recent years, yet more work is needed to realize its full potential.
The Impact of a Wearable Activity Tracker and Structured Feedback Program on Physical Activity in Hemodialysis Patients: The Step4Life Pilot Randomized Controlled Trial. [2023]People with end-stage kidney disease (ESKD) have very low physical activity, and the degree of inactivity is strongly associated with morbidity and mortality. We assessed the feasibility and effectiveness of a 12-week intervention coupling a wearable activity tracker (FitBit) and structured feedback coaching versus wearable activity tracker alone on changes in physical activity in hemodialysis patients.