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

NCT06089057 | Not Yet Recruiting DMC

• 2 other identifiers: NEPH-007-23S1IK2CX002595-01A2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lower Extremity Muscle Strength

Keywords

mobility

Outcome Measures

Primary Outcomes (3)

• Feasibility, as measured by the questionnaire, the Feasibility of Intervention Measure

  This will be a brief questionnaire known as the Feasibility of Intervention Measure, that asks participants whether the intervention seems doable to them. There are four questions, and participants are asked to rate intervention feasibility from a scale of 1 (Strongly Disagree) to 5 (Strongly Agree). Scores range from 1-5 and are calculated as the mean of all scores. Higher scores indicate greater perceived feasibility. This will not be aggregated with any other measure.

  4 months

• Feasibility, as measured by a numerical percentage of all participants who consented out of those eligible

  This will be a numeric percentage of participants who consent for the pilot trial out of all eligible participants in Aim 1. This will not be aggregated with any other measure.

  4 months

• Feasibility, as measured by a qualitative description of participants' reasons for declining

  This will be a qualitative description of potential participants' reasons for declining, if applicable. This will not be aggregated with any other measure.

  4 months

Other Outcomes (8)

• Acceptability, as measured by the questionnaire, the Acceptability of Intervention Measure

  4 months

• Acceptability, as measured by participants' qualitative descriptions of reasons for intervention enjoyability, if applicable

  4 months

• Fidelity, as measured by the percentage of sessions participants attended out of all possible sessions

  4 months

Study Arms (2)

Power training and monitored physical activity

EXPERIMENTAL

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.

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

Attention control

ACTIVE COMPARATOR

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.

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

Interventions

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

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.

Also known as: PACT to AGE WELL with CKD

Power training and monitored physical activity

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

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.

Also known as: Attention Control for PACT to AGE WELL with CKD

Attention control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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?"

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Nashville, Tennessee, 37212-2637, United States

Location

MeSH Terms

Interventions

Aging; Health

Intervention Hierarchy (Ancestors)

Growth and Development; Physiological Phenomena; Population Characteristics

Study Officials

• Devika Nair, MD

  Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Devika Nair, MD

CONTACT

(504) 210-5210; devika.nair@va.gov

Sonya L Williams, MS

CONTACT

(615) 875-2737; sonya.williams2@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Veterans will be randomized to either the intervention to an attention control. Randomization will be performed by the biostatistician. Veterans will be randomized to the intervention group (or to the attention control) using a block randomization scheme with randomly selected block sizes of 2, 4, and 6. Participants in the attention control will receive educational resources regarding the benefits of physical activity prior to intervention start (A brief document related to the importance of physical activity in kidney disease and handouts from the Center for Disease Control's recommendations for physical activity for older adults). Participants in the attention control may also receive a weekly phone call on general health.

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 18, 2023
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2029
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)