NCT06374537

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The 12-Month Randomized Trial Group will include a total of 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 will be enrolled. Randomization will be a 2:1 ratio (100 intervention, 50 control). The intervention arm will perform a 12-month exercise intervention which involves two days a week of personalized exercise rehabilitation. The control arm will receive no exercise intervention. Both arms of patients will be tested on various measures of health and function both at baseline (prior to intervention) at 6 months, and at 12 months (post intervention). This study will also investigate the effects of an exercise intervention on a subgroup of pre- and post- kidney transplant patients (PPKT Subgroup). This subgroup will include a total of 100 patients (≥ 18 years of age), who are on dialysis, or have CKD stage 4 or 5, and are considered clinically debilitated by their direct healthcare professional will be enrolled, or post- renal (kidney) transplant. This subgroup will perform 36 visits of exercise intervention which involves two days a week of personalized exercise rehabilitation. The Investigator will also utilize validated surveys and assessment tools to assess health issue management and depression severity.

Conditions

• Frailty
• Pain, Chronic
• Dialysis; Complications
• Kidney Diseases

Interventions

Type	Name	Description
OTHER	Muscle Therapy	Participants will attend 2 muscle therapy sessions a week for 12 months, for one hour each.

Timeline

• Start date: 2019-05-22
• Primary completion: 2026-05-22
• Completion: 2027-05-01
• First posted: 2024-04-18
• Last updated: 2025-08-14

Locations

1 site across 1 country: United States