"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?

This trial tests a new exercise program for people undergoing hemodialysis, a treatment for kidney failure. It compares a personalized "Move More" exercise plan with a standard exercise routine used during dialysis sessions. The goal is to determine if "Move More" can increase activity levels, reduce fatigue, and improve overall well-being. Individuals who have been on hemodialysis for at least three months and are not already very active might be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance the quality of life for those on hemodialysis.

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.

What prior data suggests that the "Move More" exercise program is safe for hemodialysis patients?

Research has shown that exercise programs during dialysis are generally safe. Patients often engage in activities like cycling or resistance exercises while receiving treatment. This setup allows for supervision, enhancing safety. However, specific safety information for the "Move More" program itself isn't detailed in the available studies.

The trial does not specify a particular phase, so there might be limited data on the safety of the "Move More" program. Nonetheless, other research has shown that exercise is well-tolerated by patients on hemodialysis. While specific reports of negative effects from "Move More" are absent, the program is designed to be personalized. This customization allows adjustments to fit each person's needs and abilities, which can help reduce risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Move More" exercise program for hemodialysis patients because it introduces a personalized approach to increasing physical activity. Unlike traditional methods that might not cater to individual preferences or capabilities, this program allows participants to choose their own weekly exercise challenges, making it more engaging and adaptable. Additionally, the use of a point system based on metabolic equivalent (MET) scores encourages gradual and measurable increases in activity. This tailored strategy aims to improve not just physical health, but also quality of life for hemodialysis patients.

What evidence suggests that the "Move More" exercise program is effective for hemodialysis patients?

Research has shown that exercise programs can greatly improve physical abilities and quality of life for people on hemodialysis. Studies have found that structured exercise during dialysis sessions enhances physical function, exercise ability, and overall well-being. In this trial, participants may be assigned to the "Move More" program, a personalized, patient-focused approach designed to boost physical activity more effectively. This method has shown promise in improving physical performance and reducing tiredness and depression compared to standard exercise programs. Alternatively, participants might engage in an Intradialytic Exercise Program, which involves exercise during dialysis sessions. Additionally, programs like "Move More" can help manage blood pressure in hemodialysis patients. Overall, strong evidence supports the significant benefits of personalized exercise programs for those undergoing dialysis. ^{2 3 4 6 7}

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

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 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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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