Your session is about to expire
← Back to Search
Behavioural Intervention
Investigate the effects of an exercise intervention on clinically debilitated dialysis patients. for Frailty
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am on dialysis, have severe kidney issues, or had a kidney transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate at which subjects will see changes in their physical abilities.
Secondary outcome measures
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 moreTrial 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.
Find a Location
Who is running the clinical trial?
University of Illinois at ChicagoLead Sponsor
609 Previous Clinical Trials
1,559,159 Total Patients Enrolled
1 Trials studying Frailty
142 Patients Enrolled for Frailty
Enrico BenedettiPrincipal InvestigatorUniversity of Illinois at Chicago
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available vacancies for patient participation in this clinical trial?
"According to the information available on clinicaltrials.gov, this particular research study is actively seeking eligible participants. The initial posting of this trial dates back to May 22nd, 2019, with the most recent update recorded on April 15th, 2024."
Answered by AI
What is the upper limit for patient participation in this medical investigation?
"Indeed, the information provided on clinicaltrials.gov states that this research is actively seeking eligible individuals. The trial was initially listed on May 22nd, 2019 and last revised on April 15th, 2024. Enrolment aims to include a total of 150 participants from one designated site."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger