Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374537
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-15
Brief Title:
Evaluate the Impact of Targeted Physical Activity on Clinically Debilitated Dialysis Patients
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
Evaluating the Impact of Targeted Physical Activity on Clinically Debilitated Dialysis Patients
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 dialysiskidney 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 21 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None