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

NCT ID: NCT06374537

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-22
• Study Completion Date: 2027-05-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Muscle Therapy

Intervention Type: OTHER

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Muscle Therapy

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

Intervention Type: OTHER

Other Intervention Names

Targeted physical activity, Exercise

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Enrico Benedetti

MD, Professor and Head Department of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enrico Benedetti

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ilaria Santi

Role: CONTACT

isanti@uic.edu

312-996-9594

Natalie Isho

Role: CONTACT

nisho@uic.edu

312-996-4708

Facility Contacts

Ilaria Santi

Role: primary

isanti@uic.edu

312-996-9594

Natalie Isho

Role: backup

nisho@uic.edu

312-996-4708

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2017-0784

Identifier Type: -

Identifier Source: org_study_id