Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-29 @ 7:30 AM
Study NCT ID:
NCT06089057
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-17
First Post:
2023-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pro-social Power Training Activity for Aging and Well-being With Chronic Kidney Disease
Sponsor:
VA Office of Research and Development
Organization:
Study Overview
Official Title:
Activation for Self-Care Needs in Older Adults With Chronic Kidney Disease: ACTIVE SENIORS With CKD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
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 is a pilot trial of a 16-week physical activity and power training program among 30 Veterans/arm with advanced chronic kidney disease. The trial aims to test whether the program is tolerable to Veterans.
Detailed Description:
This will be a randomized controlled pilot trial of a 16-week physical activity and power training intervention trial among 30 pre-frail Veterans with Stage 3B-5 chronic kidney disease. The intervention will contain in-center and at-home components. It will lay the foundation for a large-scale future randomized controlled efficacy trial aimed to reduce frailty risk among Veterans with advanced chronic kidney disease. 30 other Veterans will be part of an attention control.
The outcomes of this pilot trial are feasibility, acceptability, and fidelity. Each of these outcomes will be measured using quantitative surveys and data review as well as qualitative assessments among Veterans at trial close. As this is a pilot feasibility trial, it is intentionally not powered to detect whether the intervention has a significant effect on physical activity frequency, muscle strength, or physical frailty.
The outcomes of this pilot trial are feasibility, acceptability, and fidelity. Each of these outcomes will be measured using quantitative surveys and data review as well as qualitative assessments among Veterans at trial close. As this is a pilot feasibility trial, it is intentionally not powered to detect whether the intervention has a significant effect on physical activity frequency, muscle strength, or physical frailty.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1IK2CX002595-01A2 | NIH | None | https://reporter.nih.gov/quic… | View |