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NCT06089057 | NOT YET RECRUITING | Lower Extremity Muscle Strength

Pro-social Power Training Activity for Aging and Well-being With Chronic Kidney Disease
Sponsor:

VA Office of Research and Development

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.

Condition or disease

Lower Extremity Muscle Strength

Intervention/treatment

Pro-social Power training Activity for Aging and Well-being with Chronic Kidney Disease

Attention Control for Pro-social Power training Activity for Aging and Well-being with Chronic Kidney Disease

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : SINGLE
Masking Description : All research assistants and biostatistics personnel will be masked to each participant's assignment. Participants and study staff are unaware of group allocation at the time of recruitment and baseline assessments because randomization is performed after participants have completed baseline assessments. However, there is no blinding to group allocation after randomization.
Primary Purpose : HEALTH_SERVICES_RESEARCH
Official Title : Activation for Self-Care Needs in Older Adults With Chronic Kidney Disease: ACTIVE SENIORS With CKD
Actual Study Start Date : 2025-07-01
Estimated Primary Completion Date : 2027-04-01
Estimated Study Completion Date : 2029-04-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Participant's nephrologist and/or primary care physician agree that participant may enroll in trial
  • * Participants classified as pre-frail per Fried Frailty phenotype due to slowness (time taken to walk 15 feet is greater than 6 seconds) in Aim 1, OR who report 'YES' to any of the following
    • * "For health or physical reasons, do you have difficulty in walking a mile (5-6 blocks)?", OR
    • * "If no, have you changed the way you walk half a mile (5-6 blocks) because of underlying health problems?", OR
    • * "For health or physical reasons, do you have difficulty in climbing 1 flight of stairs (10 steps)?", OR
    • * "If no, have you changed the way you climb 1 flight of stairs (10 steps) because of health problems?"
    Exclusion Criteria
    • * Myocardial infarction or unstable angina within the prior six months based on electronic medical record review or self-report
    • * Uncontrolled cardiac arrythmia within the prior six months based on electronic medical record review or self-report
    • * Systolic blood pressure \> 180 mm Hg and/or diastolic blood pressure \> 110 mm Hg on more than one occasion within prior six months based on electronic medical record review or self-report
    • * Cerebrovascular event and/or transient ischemic attack within prior six months based on electronic medical record review or self-report
    • * Abnormal cardiac stress test within the past year based on electronic medical record review or self-report
    • * Hemoglobin of 10 g/dL or less based on electronic medical record review or self-report
    • * Class IV heart failure based on electronic medical record review or self-report
    • * Dyspnea and/or chest pain at rest
    • * Dependence on wheelchair for mobility
    • * Permanent residence in nursing home or other long-term care facility
    • * Terminal illness or other hospice-qualifying medical condition
    • * Planned move away from middle Tennessee within the next year
    • * Planned major surgery in the next six months
    • * Blindness
    • * Concurrent enrollment in physical therapy or structured exercise program
    • * Anticipated dialysis or kidney transplant in upcoming three months
    • * Non-English speaking
    • * Severe cognitive impairment based on electronic medical record review or self-report
Pro-social Power Training Activity for Aging and Well-being With Chronic Kidney Disease

Location Details

NCT06089057

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Tennessee

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, United States, 37212-2637