"Move More" Exercise Program for Hemodialysis Patients

(Move More Trial)

Overseen By Kenneth R Wilud, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: High physical activity, No clearance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6 months

40 Participants Needed

What You Need to Know Before You Apply

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?

Will 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.

Is 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. ^{1 2 3 4 5}

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. ^{2 6 7 8 9}

What 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. ^{2 9 10 11 12}

Who Is on the Research Team?

Kenneth R Wilud, PhD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

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.

I don't plan to change my dialysis type, have surgery, or move in the next 6 months.

I can communicate in English or Spanish and can sign consent.

Exclusion Criteria

Patients undergoing >150 minutes/week of prescribed physical activity at baseline

Patients who do not receive physician clearance to participate in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Testing

Participants undergo baseline testing and are randomly assigned to either the Move More or Intradialytic Exercise Program

1 week

1 visit (in-person)

Treatment

Participants engage in either the Move More personalized exercise program or the Intradialytic Exercise Program for 6 months

6 months

3 visits per week (during hemodialysis sessions)

Follow-up

Participants are monitored for changes in physical activity levels, physical function, fatigue, and depressive symptoms

6 months

Assessments at baseline, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Move More

Trial Overview 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.

How Is the Trial Designed?

Group I: Move More Personalized Exercise Program Experimental Treatment 1 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 Program Active Control 1 Intervention

Participation in an Intradialytic cycling (exercise during dialysis) physical activity prescription and resistance ("strength training") exercise for 6 months.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Published Research Related to This Trial

Patients with end-stage kidney disease on hemodialysis can significantly benefit from increased physical activity, as shown by decades of clinical trials that link exercise to improved health metrics and quality of life.

Current exercise interventions primarily focus on intradialytic cycling, but there is a shift towards more diverse exercise options and motivational tools, highlighting the need for better implementation and evaluation of these programs in dialysis clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in Dialysis: Ready for Prime Time? Morgan, AM., King, AC., Viana, J., et al.[2022]

A 12-week study involving 55 hemodialysis patients showed that those receiving structured feedback alongside a wearable activity tracker significantly increased their daily step count by an average of 920 steps, compared to just 281 steps in the tracker-only group.

The results suggest that combining feedback with activity tracking can effectively enhance physical activity in patients with end-stage kidney disease, highlighting the potential for improved health outcomes, although further research is needed to assess long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of a Wearable Activity Tracker and Structured Feedback Program on Physical Activity in Hemodialysis Patients: The Step4Life Pilot Randomized Controlled Trial. Malhotra, R., Rahimi, S., Agarwal, U., et al.[2023]

A systematic review of 56 studies involving 2586 hemodialysis patients found that combined aerobic and resistance exercise significantly improved physical functioning, peak oxygen uptake, and health-related quality of life compared to no exercise.

Resistance exercise alone also showed benefits, including increased walking distance and knee strength, while aerobic exercise alone did not significantly enhance aerobic capacity or quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intradialytic exercise training modalities on physical functioning and health-related quality of life in patients undergoing maintenance hemodialysis: systematic review and meta-analysis. Gomes Neto, M., de Lacerda, FFR., Lopes, AA., et al.[2019]

A hospital-based educational intervention that included active physical exercises significantly improved personal well-being and functional capacity in 68 patients undergoing haemodialysis over a 12-week period.

Patients showed increased autonomy in daily activities and enhanced muscle strength, with statistically significant improvements in well-being and walking speed, indicating the effectiveness of combining education with physical activity for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an educational intervention and physical exercise on the functional capacity of patients on haemodialysis. Molina-Robles, E., Colomer-Codinachs, M., Roquet-Bohils, M., et al.[2021]

Aerobic or mixed exercise training significantly improves aerobic capacity in hemodialysis patients, while resistance training is more effective for increasing muscle strength, highlighting the importance of tailored exercise programs.

All types of exercise training enhance the quality of life for hemodialysis patients, but there is a need for standardized protocols and individualized goals to ensure safety and maximize adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in patients on chronic hemodialysis: current evidence, knowledge gaps and future perspectives. Regolisti, G., Sabatino, A., Fiaccadori, E.[2021]

In a study of 282 hemodialysis patients over a follow-up period of up to 84 months, engaging in at least 4,000 steps per day was associated with a significantly lower risk of mortality, with a hazard ratio of 2.37 for those taking fewer than 4,000 steps.

The findings suggest that a minimum physical activity level of 3,752 steps can help identify patients at higher risk of death, providing a clear guideline for healthcare providers to recommend increased mobility for better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity Dose for Hemodialysis Patients: Where to Begin? Results from a Prospective Cohort Study. Matsuzawa, R., Roshanravan, B., Shimoda, T., et al.[2022]

A 12-month supervised exercise program for older adults with advanced chronic kidney disease (CKD) was found to be safe and well-tolerated, with no significant increase in adverse events reported.

Participants in the exercise group showed significant improvements in physical functioning, including a greater distance walked in the 6-minute walk test and better performance on the Timed Up and Go Test, indicating that exercise can enhance physical capabilities in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Long-term Exercise Training on Physical Performance and Cardiorespiratory Function in Adults With CKD: A Randomized Controlled Trial. Weiner, DE., Liu, CK., Miao, S., et al.[2023]

A structured physical exercise program (SPEP) during hemodialysis significantly improved physical function, exercise capacity, and quality of life in patients over a 1-year period, with 78% adherence after one year.

The program demonstrated high long-term adherence, with 43% of patients continuing after five years, indicating that integrating exercise into hemodialysis routines is feasible and beneficial for patients' health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A structured exercise programme during haemodialysis for patients with chronic kidney disease: clinical benefit and long-term adherence. Anding, K., Bär, T., Trojniak-Hennig, J., et al.[2022]

The 12-week intradialysis yoga intervention was feasible and safe for patients with end-stage renal disease, with no adverse events reported and a participation frequency of 70%.

While the yoga group had a lower completion rate (72%) compared to the educational program (100%), the study successfully demonstrated the potential for promoting physical activity in this sedentary population, providing important data for future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Intradialysis Yoga and Education in Maintenance Hemodialysis Patients. Birdee, GS., Rothman, RL., Sohl, SJ., et al.[2018]

A study involving 101 haemodialysis patients revealed that a significant number (68 out of 98) had impaired physical activity levels, with many reporting mobility issues and barriers such as fear of falls and fatigue.

Motivators for increasing physical activity included tailored exercise programs and support from healthcare professionals, highlighting the need for co-developed, individualized exercise interventions to enhance patient engagement and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cross-sectional study exploring levels of physical activity and motivators and barriers towards physical activity in haemodialysis patients to inform intervention development. Sutherland, S., Penfold, R., Doherty, A., et al.[2021]

A 12-week pilot study involving nine older hemodialysis patients showed that a combined in-hospital and home-based exercise program is feasible, with high participation rates during in-hospital sessions (89%) and moderate participation at home (56%).

Patients demonstrated improvements in physical performance and quality of life measures, indicating that such exercise programs could be beneficial, although further research with larger groups is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise program to enhance physical performance and quality of life of older hemodialysis patients: a feasibility study. Nonoyama, ML., Brooks, D., Ponikvar, A., et al.[2022]

Sedentary hemodialysis patients face a higher risk of death compared to those who engage in regular physical activity, highlighting the importance of exercise for improving health outcomes.

A randomized controlled trial is currently underway in Italy to evaluate the impact of home-based exercise programs on survival and hospitalization rates in stable dialysis patients, emphasizing the need for tailored exercise prescriptions due to the diverse physical capabilities and health conditions of this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and exercise training: a relevant aspect of the dialysis patient's care. Cupisti, A., D'Alessandro, C., Bottai, A., et al.[2021]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Exercise in Dialysis: Ready for Prime Time? [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The Impact of a Wearable Activity Tracker and Structured Feedback Program on Physical Activity in Hemodialysis Patients: The Step4Life Pilot Randomized Controlled Trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Intradialytic exercise training modalities on physical functioning and health-related quality of life in patients undergoing maintenance hemodialysis: systematic review and meta-analysis. [2019]

4. Spain pubmed.ncbi.nlm.nih.gov

Effectiveness of an educational intervention and physical exercise on the functional capacity of patients on haemodialysis. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Exercise in patients on chronic hemodialysis: current evidence, knowledge gaps and future perspectives. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Physical Activity Dose for Hemodialysis Patients: Where to Begin? Results from a Prospective Cohort Study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of Long-term Exercise Training on Physical Performance and Cardiorespiratory Function in Adults With CKD: A Randomized Controlled Trial. [2023]

8. England pubmed.ncbi.nlm.nih.gov

A structured exercise programme during haemodialysis for patients with chronic kidney disease: clinical benefit and long-term adherence. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Intradialysis Yoga and Education in Maintenance Hemodialysis Patients. [2018]

10. England pubmed.ncbi.nlm.nih.gov

A cross-sectional study exploring levels of physical activity and motivators and barriers towards physical activity in haemodialysis patients to inform intervention development. [2021]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise program to enhance physical performance and quality of life of older hemodialysis patients: a feasibility study. [2022]

12. Italy pubmed.ncbi.nlm.nih.gov

Physical activity and exercise training: a relevant aspect of the dialysis patient's care. [2021]