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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lower Extremity Muscle Strength

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


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Power training and monitored physical activity<br>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<br>* 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.<br>* Other names: PACT to AGE WELL with CKD;|
| Active Comparator: Attention control<br>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<br>* 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.<br>* Other names: Attention Control for PACT to AGE WELL with CKD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mobility