Evaluate the Impact of Targeted Physical Activity on Clinically Debilitated Dialysis Patients.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Muscle Therapy.
- Who it may be relevant to
- Registry conditions: Frailty, Pain, Chronic, Dialysis; Complications, Kidney Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating the Impact of Targeted Physical Activity on Clinically Debilitated Dialysis Patients.
Overview
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.
Interventions
- Other Muscle Therapy
Participants will attend 2 muscle therapy sessions a week for 12 months, for one hour each.
Primary outcome measures
- Rate at which subjects will see changes in their physical abilities. [Time frame: 12 months]
Secondary outcome measures (6)
- Rate at which exercise will change body composition [Time frame: 12 months]
- Rate at which exercise will change handgrip strength. [Time frame: 12 months]
- Rate at which subjects enrolled in the exercise intervention will have an overall changed sense of well-being. [Time frame: 12 months]
- Rate at which subjects enrolled in the exercise intervention will have an overall changed in their quality of life. [Time frame: 12 months]
- Rate at which subjects enrolled in the exercise intervention will have an overall decreased change in depression. [Time frame: 12 months]
- Rate at which subjects enrolled in the exercise intervention will have an overall change in pain intensity. [Time frame: 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Illinois at Chicago — Chicago
Identifiers
NCT: NCT06374537 · 2017-0784