Clinical trial NCT06374537: Evaluate the Impact of Targeted Physical Activity on Clinically Debilitated Dialysis Patients.
Official title: Evaluating the Impact of Targeted Physical Activity on Clinically Debilitated Dialysis Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty
Pain, Chronic
Dialysis; Complications
Kidney Diseases
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate at which subjects will see changes in their physical abilities.
timeFrame: 12 months
Secondary outcomes:
measure: Rate at which exercise will change body composition
timeFrame: 12 months
measure: Rate at which exercise will change handgrip strength.
timeFrame: 12 months
measure: Rate at which subjects enrolled in the exercise intervention will have an overall changed sense of well-being.
timeFrame: 12 months
measure: Rate at which subjects enrolled in the exercise intervention will have an overall changed in their quality of life.
timeFrame: 12 months
measure: Rate at which subjects enrolled in the exercise intervention will have an overall decreased change in depression.
timeFrame: 12 months
measure: Rate at which subjects enrolled in the exercise intervention will have an overall change in pain intensity.
timeFrame: 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Enrico Benedetti
role: PRINCIPAL_INVESTIGATOR
References: