Recruiting

Physical Activity

Sponsor:

University of Illinois at Chicago

Code:

NCT06374537

Conditions

Frailty

Pain, Chronic

Dialysis; Complications

Kidney Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Muscle Therapy

Study Details

Brief summary:

This research is being done to better understand the impact of the use of a specific physical activity training program (GH Method) in dialysis/kidney disease patients.

Conditions

Frailty

Pain, Chronic

Dialysis; Complications

Kidney Diseases

Study ID

NCT06374537

Start date

May 22, 2019

Status verified date

Aug, 2025

Completion date

May, 2027

Anticipated

Primary completion date

May 22, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • Adequate cognitive ability to complete the questionnaires, give consent for the study and follow the physical and diet instructions

Exclusion Criteria:

  • cardiac/pulmonary disease that contraindicate the physical training
  • Unable to give consent
  • Unable to travel to the training center

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Investigate the effects of an exercise intervention on clinically debilitated dialysis patients.

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.

no intervention: Control

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.

Interventions

Muscle Therapy

Participants will attend 2 muscle therapy sessions a week for 12 months, for one hour each.

Primary outcome measure

  • Rate at which subjects will see changes in their physical abilities. [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Aug 14, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2025-08-14.