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Behavioural Intervention

Virtual Exercise Program for Kidney Failure

N/A

Recruiting

Led By Tania Janaudis-Ferreira, PhD

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

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

consecutive individuals with end stage kidney disease (ESKD) (aged ≥18 years), classified as pre-frail (1-2 points), frail (3-4 points) or very frail (5 points) on the Fried's frailty phenotype and who are accepted or in the process of being accepted to enter in the deceased or living donor KT waiting list of the McGill University Health Centre (MUHC), Centre Hospitalier de l'Université de Montreal (CHUM) or University of Alberta Hospital (UAH) for first-time transplantation or re-transplantation

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3-month post-transplant

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a 12-week virtual exercise and education program for kidney transplant candidates is feasible. They want to know how many candidates meet the criteria, how many agree to participate, and

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves exercise and education, side effects may include typical risks associated with physical activity such as muscle soreness or strain. The educational component is not expected to have side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3-month post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 3-month post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3-month post-transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of eligible patients who consent to randomization

Proportion of patients who adhere to the interventions

Proportion of screened patients who meet eligibility criteria

+1 more

Secondary study objectives

Changes in nutrition status as assessed by Patient-Generated Subjective Global Assessment (PG-SGA)

Concentration of serum phosphorus (mmol/L)

Concentration of serum potassium (mmol/L)

+17 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: No Intervention: Usual outpatient careExperimental Treatment1 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 careExperimental Treatment1 Intervention

An intervention including exercise and education.

0 / 1Eligibility criteria met