Virtual Exercise Program for Kidney Failure

Recruiting at 1 trial location

Overseen By Amanda Rizk, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Disqualifiers: Robust frailty, Structured exercise, Hospitalized, Cognitive impairment, Cardiac condition, others

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

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this RCT is to address the feasibility of conducting a 12-week virtual pre-habilitation intervention, which includes exercise and education, in kidney transplant candidates. The intervention also includes a 5-month maintenance phase with independent home exercises (maximum of 8 months of intervention/ended early if the participant undergoes a kidney transplant). The main questions it aims to answer are: * estimate the proportion of screened patients who meet eligibility criteria * estimate the proportion of eligible patients who consent to randomization * estimate the proportion of patients who adhere to the interventions * estimate follow-up completion rates * inform the calculation of sample size requirements for a full-scale RCT * assess the acceptability of the intervention by the participants. Participants in the control group will receive usual outpatient care.

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 focuses on exercise and education for kidney transplant candidates.

Is the virtual exercise program safe for people with kidney failure?

Research shows that home-based exercise programs, including virtual and remote guidance, are generally safe for people with chronic kidney disease, including those awaiting kidney transplantation. These programs have been designed to be safe and effective in improving physical fitness and overall health. ^{1 2 3 4 5}

How is the Virtual Home-based Physical Pre-habilitation treatment different from other treatments for kidney failure?

The Virtual Home-based Physical Pre-habilitation treatment is unique because it allows patients with kidney failure to engage in exercise programs from home using virtual guidance, which can improve their physical function and readiness for kidney transplantation. This approach is different from traditional in-person rehabilitation as it provides remote supervision and flexibility, making it more accessible for patients who may have difficulty traveling to a center. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Virtual Home-based Physical Pre-habilitation for kidney failure?

Research shows that telerehabilitation, which involves exercise programs delivered via video calls, can help improve physical performance in older adults and those recovering from hospital stays. This suggests that a virtual exercise program could be beneficial for people with kidney failure as well. ^{9 10 11 12 13}

Who Is on the Research Team?

Tania Janaudis-Ferreira, PhD

Principal Investigator

Research Institute of McGill University Health Centre (RI-MUHC)

Are You a Good Fit for This Trial?

This trial is for English or French-speaking adults over 18 with end-stage kidney disease who are frail to very frail and on the transplant list at specific Canadian hospitals. They must be able to use videoconferencing, either alone or with help, but those without internet can borrow a tablet.

Inclusion Criteria

I am over 18, have end stage kidney disease, and am on the transplant list.

You are technologically able to connect with an online videoconferencing platform by invitation via email, or can access the internet through a borrowed tablet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-habilitation

Participants undergo a 12-week virtual home-based supervised exercise program with educational components

12 weeks

Virtual visits

Maintenance

Participants continue with a 5-month maintenance phase involving independent home exercises

5 months

Virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after the intervention

3 months post-transplant

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Home-based Physical Pre-habilitation

Trial Overview The study tests if a virtual home-based exercise and education program helps people waiting for kidney transplants. It's a randomized controlled trial comparing this pre-habilitation intervention against usual care over up to 8 months.

How Is the Trial Designed?

Group I: No Intervention: Usual outpatient care Experimental Treatment 1 Intervention

The control group will receive usual outpatient care provided to kidney transplant candidates. All participants in the control group will receive educational resources received by intervention group participants at trial completion.

Group II: Experimental: Pre-habilitation plus usual outpatient care Experimental Treatment 1 Intervention

An intervention including exercise and education.

Who Is Running the Clinical Trial?

McGill University Health Centre/Research Institute of the McGill University Health Centre

Lead Sponsor

Trials

476

Recruited

170,000+

The Kidney Foundation of Canada

Collaborator

Trials

16

Recruited

3,200+

Published Research Related to This Trial

Exercise interventions delivered via telerehabilitation showed limited evidence of effectiveness in improving physical function and quality of life for recently hospitalized patients, based on a review of three studies with 201 participants.

Despite the limited effectiveness, telerehabilitation was associated with high attendance rates and patient satisfaction, suggesting it may be a valuable option for delivering exercise programs in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Exercise Interventions Supported by Telerehabilitation For Recently Hospitalized Adult Medical Patients: A Systematic Review. Leslie, S., Tan, J., McRae, PJ., et al.[2022]

Guided telerehabilitation has shown to be at least as effective as traditional rehabilitation methods for improving functional performance in older adults, based on a systematic review of 26 randomized controlled trials.

No control interventions were found to be superior to telerehabilitation, indicating that this approach could be a viable alternative for community-dwelling older adults, although further studies with lower bias are needed to refine intervention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of guided telerehabilitation on functional performance in community-dwelling older adults: A systematic review. Gamble, CJ., van Haastregt, J., van Dam van Isselt, EF., et al.[2023]

Home-based cardiac telerehabilitation significantly improves heart rate, VO2 peak, 6-minute walk distance, quality of life, and reduces readmission rates in patients with heart failure, based on a meta-analysis of 16 studies involving 4557 participants.

While home-based telerehabilitation shows benefits, it does not significantly improve left ventricular ejection fraction compared to usual care, and it is not more effective than center-based cardiac rehabilitation in terms of outcome indicators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of home-based cardiac telerehabilitation in patients with heart failure: A systematic review and meta-analysis of randomised controlled trials. Gao, Y., Wang, N., Zhang, L., et al.[2023]

A prototype telerehabilitation system for home-based strengthening exercises was developed and showed sufficient validity in monitoring exercise performance and cardiovascular parameters in real-time.

The system, which includes a resistance chair and personalized feedback managed by a rehabilitation team, has potential benefits for older adults and warrants further evaluation in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive resistance chair to promote strengthening exercise in older adults. Jeong, IC., Finkelstein, J.[2016]

A randomized controlled trial involving 142 patients showed that a 2-week interactive virtual telerehabilitation program is as effective as conventional outpatient physical therapy in improving knee function after total knee arthroplasty.

Both rehabilitation methods led to significant improvements in knee movement, muscle strength, walking speed, and pain levels, suggesting that telerehabilitation could be a viable option for patients who face challenges in attending traditional therapy sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an interactive virtual telerehabilitation system in patients after total knee arthoplasty: a randomized controlled trial. Piqueras, M., Marco, E., Coll, M., et al.[2022]

A 12-week home exercise prehabilitation program using remote guidance significantly improved physical fitness in patients with end-stage renal disease awaiting kidney transplantation, as evidenced by increased performance in the 6-minute walk test and other physical assessments.

The study demonstrated that this remote coaching approach is both safe and feasible, providing a valuable option for enhancing the physical function of patients in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Face-to-Face Mentoring, Remotely Supervised Home Exercise Prehabilitation to Improve Physical Function in Patients Awaiting Kidney Transplantation: A Randomized Clinical Trial. Ma, X., Zhang, Z., Peng, M., et al.[2022]

The study will assess the feasibility of a home exercise program based on Enhanced Recovery After Surgery (ERAS) for 47 patients with end-stage renal disease (ESRD) awaiting kidney transplantation, focusing on personalized family exercise that includes aerobic, resistance, and flexibility training.

Key outcomes will include improvements in physical function measured by tests like the 6-minute walking test and grip strength, as well as secondary indicators of quality of life and psychological well-being after transplantation, evaluated at multiple time points before and after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study on the effect of pre-rehabilitation home-based on patients undergoing kidney transplantation with end-stage renal disease: A study protocol. Ma, X., Zhang, Z., Yao, B., et al.[2023]

A randomized controlled trial involving 114 kidney transplant candidates (38 frail and 76 non-frail) is investigating the effectiveness of a multimodal prehabilitation program that includes exercise, nutritional support, and psychological advice to improve outcomes after kidney transplantation.

The study aims to demonstrate that this prehabilitation approach can reduce negative outcomes by 25% in frail patients and 12.5% in non-frail patients at 90 days post-transplant, highlighting its potential to enhance recovery and quality of life for patients with chronic kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The FRAILMar Study Protocol: Frailty in Patients With Advanced Chronic Kidney Disease Awaiting Kidney Transplantation. A Randomized Clinical Trial of Multimodal Prehabilitation. Pérez-Sáez, MJ., Morgado-Pérez, A., Faura, A., et al.[2021]

The PreCareTx study will assess the effectiveness of a 12-week multimodal prehabilitation program for kidney transplant candidates, focusing on improving their frailty status and overall health before surgery, with 128 participants split between prehabilitation and usual care groups.

The study will also evaluate the safety, feasibility, and acceptability of the prehabilitation program, aiming to identify barriers and facilitators for its implementation in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PREhabilitation of CAndidates for REnal Transplantation (PreCareTx) study: protocol for a hybrid type I, mixed method, randomised controlled trial. Quint, EE., Haanstra, AJ., van der Veen, Y., et al.[2023]

Intradialytic and out-of-clinic exercise programs are safe and effective for improving fitness in end-stage chronic kidney disease (CKD) patients, but the COVID-19 pandemic has disrupted these programs, increasing the risk of physical inactivity.

The study proposes a personalized, multicomponent home-based exercise program for CKD patients, including a fitness evaluation tool to help them safely adapt the program to their individual fitness levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicomponent Home-Based Training Program for Chronic Kidney Disease Patients during Movement Restriction. López-Torres, O., Azpeitia-Martínez, C., González-Gross, M., et al.[2023]

A 12-week home-based aerobic exercise program significantly improved cardiopulmonary capacity and functional abilities in 29 overweight patients with chronic kidney disease, with improvements in parameters like VO2peak and walking distance.

The exercise group also experienced notable reductions in blood pressure, indicating that home-based exercise is a safe and effective intervention for enhancing health in non-dialysis-dependent CKD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of home-based aerobic exercise on the physical capacity of overweight patients with chronic kidney disease. Aoike, DT., Baria, F., Kamimura, MA., et al.[2018]

A study involving 56 patients with chronic kidney disease showed that a 12-week non-immersive virtual reality exercise program significantly improved various measures of physical function, including gait speed and balance tests.

Participants demonstrated high adherence to the exercise program, with over 70% consistently engaging in the VR exercises, indicating that this approach is not only effective but also well-received by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An intradialytic non-immersive virtual reality exercise programme: a crossover randomized controlled trial. Martínez-Olmos, FJ., Gómez-Conesa, AA., García-Testal, A., et al.[2022]

A pilot study involving 24 kidney transplant candidates showed that a prehabilitation program, consisting of weekly physical therapy and at-home exercises, significantly improved physical activity levels by 64% over two months.

Participants who underwent prehabilitation had a shorter hospital stay after kidney transplant (5 days) compared to matched controls (10 days), suggesting that prehabilitation may enhance recovery outcomes post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation prior to kidney transplantation: Results from a pilot study. McAdams-DeMarco, MA., Ying, H., Van Pilsum Rasmussen, S., et al.[2023]

Citations

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

The Effectiveness of Exercise Interventions Supported by Telerehabilitation For Recently Hospitalized Adult Medical Patients: A Systematic Review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of guided telerehabilitation on functional performance in community-dwelling older adults: A systematic review. [2023]

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

Effectiveness of home-based cardiac telerehabilitation in patients with heart failure: A systematic review and meta-analysis of randomised controlled trials. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Interactive resistance chair to promote strengthening exercise in older adults. [2016]

5. Sweden pubmed.ncbi.nlm.nih.gov

Effectiveness of an interactive virtual telerehabilitation system in patients after total knee arthoplasty: a randomized controlled trial. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Face-to-Face Mentoring, Remotely Supervised Home Exercise Prehabilitation to Improve Physical Function in Patients Awaiting Kidney Transplantation: A Randomized Clinical Trial. [2022]

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

Study on the effect of pre-rehabilitation home-based on patients undergoing kidney transplantation with end-stage renal disease: A study protocol. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The FRAILMar Study Protocol: Frailty in Patients With Advanced Chronic Kidney Disease Awaiting Kidney Transplantation. A Randomized Clinical Trial of Multimodal Prehabilitation. [2021]

9. England pubmed.ncbi.nlm.nih.gov

PREhabilitation of CAndidates for REnal Transplantation (PreCareTx) study: protocol for a hybrid type I, mixed method, randomised controlled trial. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Multicomponent Home-Based Training Program for Chronic Kidney Disease Patients during Movement Restriction. [2023]

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

Impact of home-based aerobic exercise on the physical capacity of overweight patients with chronic kidney disease. [2018]

12. England pubmed.ncbi.nlm.nih.gov

An intradialytic non-immersive virtual reality exercise programme: a crossover randomized controlled trial. [2022]

13. Denmark pubmed.ncbi.nlm.nih.gov

Prehabilitation prior to kidney transplantation: Results from a pilot study. [2023]