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

Official title

Activation for Self-Care Needs in Older Adults With Chronic Kidney Disease: ACTIVE SENIORS With CKD

Overview

This is a pilot trial of a 16-week physical activity and power training program among up to 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 up to 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. Up to 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.

Interventions

• Behavioral Pro-social Power training Activity for Aging and Well-being with Chronic Kidney Disease
  This is a 16-week power-training and physical activity-focused intervention that contains group in-center and individual 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.
• Behavioral Attention Control for Pro-social Power training Activity for Aging and Well-being with Chronic Kidney Disease
  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.

Primary outcome measures

• Feasibility, as measured by the questionnaire, the Feasibility of Intervention Measure [Time frame: 4 months]
• Feasibility, as measured by a numerical percentage of all participants who consented out of those eligible [Time frame: 4 months]
• Feasibility, as measured by a qualitative description of participants' reasons for declining [Time frame: 4 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

United States · 1 center

• Tennessee Valley Healthcare System Nashville Campus, Nashville, TN — Nashville

Identifiers

NCT: NCT06089057 · NEPH-007-23S · 1IK2CX002595-01A2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗