Back to resultsPro-social Power Training Activity for Aging and Well-being With Chronic Kidney Disease
Primary Purpose
Lower Extremity Muscle Strength
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pro-social Power training Activity for Aging and Well-being with Chronic Kidney Disease
Attention Control for Pro-social Power training Activity for Aging and Well-being with Chronic Kidney Disease
Sponsored by
About this trial
This is an interventional health services research trial for Lower Extremity Muscle Strength focused on measuring mobility
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
Sites / Locations
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Power training and monitored physical activity
Attention control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT06089057
First Posted
September 28, 2023
Last Updated
October 20, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT06089057
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2024 (Anticipated)
Primary Completion Date
April 1, 2027 (Anticipated)
Study Completion Date
April 1, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Extremity Muscle Strength
Keywords
mobility
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Power training and monitored physical activity
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pro-social Power training Activity for Aging and Well-being with Chronic Kidney Disease
Other Intervention Name(s)
PACT to AGE WELL with CKD
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Attention Control for Pro-social Power training Activity for Aging and Well-being with Chronic Kidney Disease
Other Intervention Name(s)
Attention Control for PACT to AGE WELL with CKD
Intervention Description
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 Measure Information:
Title
Feasibility, as measured by the questionnaire, the Feasibility of Intervention Measure
Description
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.
Time Frame
4 months
Title
Feasibility, as measured by a numerical percentage of all participants who consented out of those eligible
Description
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.
Time Frame
4 months
Title
Feasibility, as measured by a qualitative description of participants' reasons for declining
Description
This will be a qualitative description of potential participants' reasons for declining, if applicable. This will not be aggregated with any other measure.
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Acceptability, as measured by the questionnaire, the Acceptability of Intervention Measure
Description
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.
Time Frame
4 months
Title
Acceptability, as measured by participants' qualitative descriptions of reasons for intervention enjoyability, if applicable
Description
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.
Time Frame
4 months
Title
Fidelity, as measured by the percentage of sessions participants attended out of all possible sessions
Description
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.
Time Frame
4 months
Title
Fidelity, as measured by accelerometer step count during prior week
Description
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.
Time Frame
5 months, 6 months, and 7 months
Title
Fidelity, as measured by the questionnaire, the Physical Activity Scale for the Elderly
Description
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.
Time Frame
5 months, 6 months, and 7 months
Title
Fidelity, as measured by participants' descriptions of reasons for adherence vs. nonadherence
Description
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.
Time Frame
7 months
Title
Adverse events, as measured by the the number of participants who report adverse events from the Common Terminology Criteria for Adverse Events, v5.0
Description
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.
Time Frame
7 months
Title
Adverse events, as measured by the type of adverse events reported on the Common Terminology Criteria for Adverse Events, v5.0
Description
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.
Time Frame
7 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Devika Nair, MD
Phone
(504) 210-5210
Email
devika.nair@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Sonya L Williams, MS
Phone
(615) 875-2737
Email
sonya.l.williams@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Devika Nair, MD
Organizational Affiliation
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-2637
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Devika Nair, MD
Phone
504-210-5210
Email
devika.nair@va.gov
First Name & Middle Initial & Last Name & Degree
Sonya L Williams, MS
Phone
(615) 875-2737
Email
sonya.l.williams@vumc.org
First Name & Middle Initial & Last Name & Degree
Devika Nair, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pro-social Power Training Activity for Aging and Well-being With Chronic Kidney Disease
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