Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06374537

Evaluating the Impact of Targeted Physical Activity on Clinically Debilitated Dialysis Patients

Led by University of Illinois at Chicago · Updated on 2025-08-14

150

Participants Needed

1

Research Sites

49 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how a specific physical activity training program called the GH Method affects patients with kidney disease who are on dialysis or have advanced chronic kidney disease (stage 4 or 5). This study aims to understand the impact of targeted exercise on clinically debilitated dialysis patients, including a subgroup of pre- and post-kidney transplant patients. The research involves comparing health and function measures over time to assess the effects of exercise. The study includes 150 patients aged 18 or older who are either on dialysis or have chronic kidney disease stage 4 or 5 and are considered clinically debilitated. Participants will be randomly assigned in a 2:1 ratio to either an exercise intervention group or a control group. The intervention group will attend personalized exercise rehabilitation sessions twice a week for one hour each, lasting 12 months (96 sessions total). The control group will not receive any exercise intervention but will undergo the same health and function assessments. A subgroup of 100 patients, including pre- and post-kidney transplant patients, will also participate in a similar exercise program with 36 visits. Participants will attend visits for data collection at the start, 6 months, and 12 months, each lasting about 2-3 hours. These visits will include tests to evaluate cardiovascular and functional responses to the exercise program. Researchers will use validated surveys to assess health management and depression severity. The primary outcome is the rate of change in physical abilities over 12 months. Secondary outcomes include changes in body composition, handgrip strength, overall well-being, quality of life, depression, and pain intensity. The study observes participants for up to one year from the start of the intervention.

CONDITIONS

Brief Title

Evaluate the Impact of Targeted Physical Activity on Clinically Debilitated Dialysis Patients.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinically debilitated patients currently on dialysis, or with chronic kidney disease stage 4 (GFR between 15 and 29), or stage 5 (GFR below 15), or post-kidney transplant (for a specific subgroup) as determined by a healthcare professional
  • Adequate cognitive ability to complete questionnaires, give consent, and follow physical and diet instructions
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Cardiac or pulmonary disease that contraindicates physical training
  • Unable to give consent
  • Unable to travel to the training center

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 months

Participants in the exercise group attend personalized muscle therapy sessions twice a week for 12 months. Control participants do not receive exercise intervention. Both groups undergo health and function assessments at baseline, 6 months, and 12 months.

Twice weekly exercise sessions for intervention group; 3 assessment visits (baseline, 6 months, 12 months) for all participants

Trial Site Locations

Total: 1 location

1

University of Illinois at Chicago

Chicago, Illinois, United States, 60612

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Research Team

I

Ilaria Santi

N

Natalie Isho

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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