Clinical trial NCT06089057: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lower Extremity Muscle Strength
Keywords: mobility
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-10-18
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Feasibility, as measured by the questionnaire, the Feasibility of Intervention Measure
timeFrame: 4 months
measure: Feasibility, as measured by a numerical percentage of all participants who consented out of those eligible
timeFrame: 4 months
measure: Feasibility, as measured by a qualitative description of participants' reasons for declining
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
measure: Acceptability, as measured by the questionnaire, the Acceptability of Intervention Measure
timeFrame: 4 months
measure: Acceptability, as measured by participants' qualitative descriptions of reasons for intervention enjoyability, if applicable
timeFrame: 4 months
measure: Fidelity, as measured by the percentage of sessions participants attended out of all possible sessions
timeFrame: 4 months
measure: Fidelity, as measured by accelerometer step count during prior week
timeFrame: 5 months, 6 months, and 7 months
measure: Fidelity, as measured by the questionnaire, the Physical Activity Scale for the Elderly
timeFrame: 5 months, 6 months, and 7 months
measure: Fidelity, as measured by participants' descriptions of reasons for adherence vs. nonadherence
timeFrame: 7 months
measure: Adverse events, as measured by the the number of participants who report adverse events from the Common Terminology Criteria for Adverse Events, v5.0
timeFrame: 7 months
measure: Adverse events, as measured by the type of adverse events reported on the Common Terminology Criteria for Adverse Events, v5.0
timeFrame: 7 months
Locations:
city: Nashville
country: United States
facility: Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
state: Tennessee
Study officials:
affiliation: Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
name: Devika Nair, MD
role: PRINCIPAL_INVESTIGATOR
References: