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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Diseases; Frailty; Pain, Chronic; Dialysis; Complications
• Intervention / Treatment: Other: Muscle Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ilaria Santi; Phone Number: 312-996-9594; Email: isanti@uic.edu
• Study Contact Backup: Name: Natalie Isho; Phone Number: 312-996-4708; Email: nisho@uic.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois at Chicago
      • Contact: Ilaria Santi; Phone Number: 312-996-9594; Email: isanti@uic.edu
      • Contact: Natalie Isho; Phone Number: 312-996-4708; Email: nisho@uic.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Muscle Therapy; Participants will attend 2 muscle therapy sessions a week for 12 months, for one hour each.; Other Names: Targeted physical activity, Exercise
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate at which subjects will see changes in their physical abilities.	Participants will see improvements in their physical abilities after 12 months in the exercise training sessions. This will be assessed by comparing baseline, 6 months, 12 months, using a Short Physical Performance Battery test. This test requires the assessment of walking speed (time to walk 3 meters), a balance test (standing in 3 different positions for 10 seconds each-tandem, semi tandem, and side by side), and the time it takes to sit and stand 5 times in a chair (see above). Scoring is based on a scale of 0-12, lower numbers representing worse performance.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate at which subjects enrolled in the exercise intervention will have an overall changed sense of well-being.	Participants will be asked about their overall general health using the PROMIS.	12 months
Rate at which subjects enrolled in the exercise intervention will have an overall changed in their quality of life.	Participants will be asked about their mental health using SF 36.	12 months
Rate at which subjects enrolled in the exercise intervention will have an overall decreased change in depression.	Participants will be asked about their mental health using the BDI.	12 months
Rate at which subjects enrolled in the exercise intervention will have an overall change in pain intensity.	Participants will be asked about their overall pain intensity using the Numeric Rating Scale for Pain.	12 months
Rate at which exercise will change body composition	With this hypothesis the Investigator will test whether muscle mass (DEXA scan) changes after 6 months and 12 months of an exercise intervention. Baseline measurement will be performed before the intervention, at 6 months and 12 months , with muscle mass measured by DEXA.	12 months
Rate at which exercise will change handgrip strength.	With this hypothesis the Investigator will test whether muscle strength (dynamometer) changes after 6 months and 12 months of an exercise intervention. Baseline measurement will be performed before the intervention, at 6 months and 12 months, with strength measured by dynamometer.	12 months

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Investigators: Principal Investigator: Enrico Benedetti, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2019
• Primary Completion (Estimated): May 22, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pain; Neurologic Manifestations; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Frailty; Chronic Pain; Kidney Diseases
• Other Study ID Numbers: 2017-0784

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No