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Structured Exercise Program for Kidney Transplant Candidates (SPaRKT Trial)

N/A

Recruiting

Led By Anoop Sheshadri, MD, MAS

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

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

Must have

Having a living donor kidney

On hemodialysis or peritoneal dialysis

Must not have

Non-English speakers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-kt)

Summary

This trial is looking at whether or not a structured exercise program can help older patients with end-stage kidney disease who are waiting for a kidney transplant. The hope is that the exercise program will improve their physical performance and quality of life.

Who is the study for?

This trial is for older adults (50+) with end-stage kidney disease on dialysis, who have a living donor for a kidney transplant and are not currently in an exercise program. They must have limited physical abilities (SPPB score ≤ 10), and access to both telephone and internet. Non-English speakers cannot participate.

What is being tested?

The study tests an 8-week home-based structured exercise program designed for older patients awaiting kidney transplants, involving caregivers in the process. It compares the effects of this program plus usual care against usual care alone on patients' physical performance, activity levels, quality of life, and post-transplant hospitalization days.

What are the potential side effects?

Since this trial involves an exercise program rather than medication, side effects may include typical exercise-related issues such as muscle soreness or fatigue. However, these should be mild and temporary as the program is tailored to individuals with limited physical ability.

Eligibility Criteria

Inclusion Criteria

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

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I have a living donor for a kidney transplant.

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I am currently on dialysis.

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I am 50 years old or older.

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My physical ability score is 10 or less.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not speak English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-kt)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-kt)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8 weeks (post-program completion), approximately 20 weeks (3-months post-kt) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Short Physical Performance Battery (SPPB)

Change in Step Count

Secondary study objectives

Change in 6 minute walk distance (6MWD)

Change in Center for Epidemiological Studies- Depression (CES-D) score

Change in Dialysis Symptoms Index (DSI) score

+6 more

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Weekly CoachingActive Control1 Intervention

Weekly coaching per the SPaRKT protocol with titrated increases in physical activity and resistance exercise

Group II: Weekly Coaching + Caregiver ParticipationActive Control1 Intervention

Weekly coaching per the SPaRKT protocol with titrated increases in physical activity and resistance exercise with the addition of caregiver participation to promote adherence and engagement

Group III: Usual CarePlacebo Group1 Intervention

Patients randomized to usual care will receive recommendations for exercise based on the Surgeon General's recommendations for physical activity among adults as well as the American Heart Association and American College of Sports Medicine recommendations for older individuals or individuals with chronic conditions. These guidelines are applicable to this patient population. Patients will not receive coaching but will receive accelerometers to obtain data for comparison to the intervention groups at each time point (baseline, 8 weeks, and 3 months post-KT).

0 / 5Eligibility criteria met