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

University of Illinois

Status: Enrolling

Conditions: Kidney Diseases; Pain, Chronic; Frailty; Dialysis; Complications

Treatments: Other: Muscle Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06374537

2017-0784

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Other: Muscle Therapy

Control

No Intervention group

Description:

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.