Evaluate the Impact of Targeted Physical Activity on Clinically Debilitated Dialysis Patients.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Illinois at Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
cardiac/pulmonary disease that contraindicate the physical training
Unable to give consent
Unable to travel to the training center
Trial design
Design model
Parallel
Treatments tested in this trial
Muscle Therapy
Other interventionParticipants will attend 2 muscle therapy sessions a week for 12 months, for one hour each.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Investigate the effects of an exercise intervention on clinically debilitated dialysis patients.Experimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
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.
Time frame
12 monthsSecondary outcomes
1
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.
Time frame
12 months2
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.
Time frame
12 months3
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.
Time frame
12 months4
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.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov