Frailty Clinical Trial
Official title:
Evaluating the Impact of Targeted Physical Activity on Clinically Debilitated Dialysis Patients.
NCT number | NCT06374537 |
Other study ID # | 2017-0784 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 22, 2019 |
Est. completion date | May 2027 |
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | May 2027 |
Est. primary completion date | May 22, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Illinois at Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 12 months | |
Secondary | 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. | 12 months | |
Secondary | 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. | 12 months | |
Secondary | 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. | 12 months | |
Secondary | Rate at which subjects enrolled in the exercise intervention will have an overall decreased change in depression. | Participants will be asked about their mental health using the BDI. | 12 months | |
Secondary | Rate at which subjects enrolled in the exercise intervention will have an overall change in pain intensity. | Participants will be asked about their overall pain intensity using the Numeric Rating Scale for Pain. | 12 months |
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