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

NCT06374537 | Recruiting

• 1 other identifier: 2017-0784
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Rate at which exercise will change body composition

  12 months

• Rate at which exercise will change handgrip strength.

  12 months

• Rate at which subjects enrolled in the exercise intervention will have an overall changed sense of well-being.

  12 months

• Rate at which subjects enrolled in the exercise intervention will have an overall changed in their quality of life.

  12 months

• Rate at which subjects enrolled in the exercise intervention will have an overall decreased change in depression.

  12 months

Study Arms (2)

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

EXPERIMENTAL

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

Control

NO INTERVENTION

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 OTHER

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

Also known as: Targeted physical activity, Exercise

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Frailty; Chronic Pain; Kidney Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Enrico Benedetti

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilaria Santi

CONTACT

312-996-9594; isanti@uic.edu

Natalie Isho

CONTACT

312-996-4708; nisho@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor and Head Department of Surgery

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: May 22, 2019
• Primary Completion (Estimated): May 22, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)