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Behavioural Intervention

Muscle Therapy for Dialysis Patients

N/A

Recruiting

Led By Enrico Benedetti

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

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

Must have

Clinically debilitated patients, currently on dialysis, or have CKD 4 (GFR between 15 and 29), or have CKD 5 (GFR below 15), or post-kidney transplant (for PPKT Subgroup only) as stated by patient's health care professional

Be older than 18 years old

Must not have

Unable to give consent

Unable to travel to the training center

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to study how a specific exercise program (GH Method) affects patients with kidney disease who are on dialysis."

Who is the study for?

This trial is for patients who are weak and on dialysis, or have advanced chronic kidney disease (CKD stages 4 and 5), or are post-kidney transplant. They must be able to understand the study, consent to participate, and follow physical activity and diet instructions. Those with heart/lung diseases that make exercise unsafe or who can't travel to the training center cannot join.

What is being tested?

The trial studies a specific physical activity program called GH Method in patients with kidney issues undergoing dialysis. It aims to see if this targeted muscle therapy improves their overall health condition.

What are the potential side effects?

While not explicitly stated, potential side effects may include muscle soreness, fatigue, joint pain from increased physical activity especially given the frailty of participants.

Eligibility Criteria

Inclusion Criteria

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

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I am on dialysis, have severe kidney issues, or had a kidney transplant.

Exclusion Criteria

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

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I am unable to understand and give consent for treatment.

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I cannot travel to the training center.

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I have heart or lung conditions that prevent me from undergoing physical training.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Rate at which subjects will see changes in their physical abilities.

Secondary study objectives

Rate at which exercise will change body composition

Rate at which exercise will change handgrip strength.

Rate at which subjects enrolled in the exercise intervention will have an overall change in pain intensity.

+3 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

Active Control

Group I: Investigate the effects of an exercise intervention on clinically debilitated dialysis patients.Experimental Treatment1 Intervention

150 patients from UI Health (≥ 18 years of age), who are on dialysis, or have chronic kidney disease stage 4 (CKD 4 = GFR between 15 and 29), or have chronic kidney disease stage 5 (CKD 5 = GFR below 15) and are considered clinically debilitated by their direct healthcare professional. After the initial baseline visit, subjects will come twice weekly, for roughly 1 hour each session, for 12 months (96 visits total). Subjects will also come in for data collection visits at baseline (prior to starting the exercise program), 6 months, and 12 months. Each of those visits will take about 2-3 hours. All testing done in the 3 test visits will help assess the patient's cardiovascular and functional responses and/or changes to the exercise intervention.

Group II: ControlActive Control1 Intervention

The control arm will receive no exercise intervention. Subjects will also come in for data collection visits at baseline (prior to starting the exercise program), 6 months, and 12 months. Each of those visits will take about 2-3 hours. All testing done in the 3 test visits will help assess the patient's cardiovascular and functional responses.

0 / 4Eligibility criteria met