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

VA Office of Research and Development

Status: Begins enrollment this month

Conditions: Lower Extremity Muscle Strength

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

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06089057

NEPH-007-23S

1IK2CX002595-01A2 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

30 participants in 2 patient groups

Power training and monitored physical activity

Experimental group

Description:

This is a 16-week power-training and physical activity-focused intervention that contains in-center and at-home components and motivational coaching. Participants will meet 2-3 times per week for the in-center power training. Participants will also be asked to wear accelerometers at home in order for their physical activity frequency to be measured.

Treatment:

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

Attention control

Active Comparator group

Description:

This will be the attention control arm that will involve receipt of a physical activity education booklet, use of an accelerometer, and weekly check-in calls. No power training or motivational coaching will be delivered.

Treatment:

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