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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lower Extremity Muscle Strength
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Devika Nair, MD; Phone Number: (504) 210-5210; Email: devika.nair@va.gov
• Study Contact Backup: Name: Sonya L Williams, MS; Phone Number: (615) 875-2737; Email: sonya.l.williams@vumc.org

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212-2637
      • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
      • Contact: Sonya L Williams, MS; Phone Number: (615) 875-2737; Email: sonya.l.williams@vumc.org
      • Principal Investigator: Devika Nair, MD
      • Contact: Devika Nair, MD; Phone Number: 504-210-5210; Email: devika.nair@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Power training and monitored physical activity; 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; 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.; Other Names: PACT to AGE WELL with CKD
Active Comparator: Attention control; 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; 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.; Other Names: Attention Control for PACT to AGE WELL with CKD

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability, as measured by the questionnaire, the Acceptability of Intervention Measure	This will be a brief questionnaire known as the Acceptability of Intervention Measure, that asks participants whether the intervention seems acceptable and/or enjoyable to them. There are four questions, and participants are asked to rate intervention acceptability 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 acceptability. This will not be aggregated with any other measure.	4 months
Acceptability, as measured by participants' qualitative descriptions of reasons for intervention enjoyability, if applicable	This will be a qualitative description of participants' reasons they found the intervention enjoyable to participate in, if applicable. This will not be aggregated with any other measure.	4 months
Fidelity, as measured by the percentage of sessions participants attended out of all possible sessions	This will be a percentage, measured by the number of sessions a participant attended out of all possible sessions that could have have been attended. This will not be aggregated with any other measure.	4 months
Fidelity, as measured by participants' descriptions of reasons for adherence vs. nonadherence	This will be a qualitative description of participants' reasons for adhering to the intervention or not, as applicable. This will not be aggregated with any other measure.	7 months
Adverse events, as measured by the type of adverse events reported on the Common Terminology Criteria for Adverse Events, v5.0	This will be the type of adverse events as reported by participants from the Common Terminology Criteria for Adverse Events version 5.0. This will not be aggregated with any other measure.	7 months
Fidelity, as measured by accelerometer step count during prior week	This will be the step count during the prior week recorded on an accelerometer worn by each participant. This will be measured at each of the following time points: one, two, and three months after intervention close. That is to say, this will be measured at 5 months, 6 months, and 7 months after intervention start. This will not be aggregated with any other measure.	5 months, 6 months, and 7 months
Fidelity, as measured by the questionnaire, the Physical Activity Scale for the Elderly	This will be measured using the questionnaire, the Physical Activity Scale for the Elderly, a ten-item questionnaire that inquires about the frequency, duration, and intensity of physical activity during the prior week. Scores range from 0-793, with higher scores indicating completion of more frequent and/or intense physical activity. This will be measured at each of the following time points: one, two, and three months after intervention close. That is to say, this will be measured at 5 months, 6 months, and 7 months after intervention start. This will not be aggregated with any other measure.	5 months, 6 months, and 7 months
Adverse events, as measured by the the number of participants who report adverse events from the Common Terminology Criteria for Adverse Events, v5.0	This will be the total number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 5.0. This will not be aggregated with any other measure.	7 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Devika Nair, MD, Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: mobility
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: NEPH-007-23S; 1IK2CX002595-01A2 (Other Grant/Funding Number: CSRD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No