Lower Extremity Muscle StrengthNCT06089057
Pro-social Power Training Activity for Aging and Well-being With Chronic Kidney Disease
A study testing Pro-social Power training Activity for Aging and Well-being with Chronic Kidney Disease in people with Lower Extremity Muscle Strength, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lower Extremity Muscle Strength
- What is being tested?
- Pro-social Power training Activity for Aging and Well-being with Chronic Kidney Disease
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2026to 1 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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?"
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637
About this study
Official title: 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 up to 30 Veterans/arm with advanced chronic kidney disease. The trial aims to test whether the program is tolerable to Veterans.
Read the detailed description
This will be a randomized controlled pilot trial of a 16-week physical activity and power training intervention trial among up to 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. Up to 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.
- Conditions
- Lower Extremity Muscle Strength
- Being tested
- 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
- Keywords
- mobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro-social Power training Activity for Aging and Well-being with Chronic Kidney DiseaseBehavioural
Also called PACT to AGE WELL with CKD
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.
Attention Control for Pro-social Power training Activity for Aging and Well-being with Chronic Kidney DiseaseBehavioural
Also called Attention Control for PACT to AGE WELL with CKD
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Attention Control for Pro-social Power training Activity for Aging and Well-being with Chronic Kidney Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start15 Jul 2026
- Primary completion29 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity Muscle StrengthStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Devika Nair, MD, Principal investigator, Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089057
- Sponsor's protocol ID
- NEPH-007-23S
- Other IDs
- 1IK2CX002595-01A2
- Status last verified
- Jul 2026
- First submitted
- 28 Sep 2023
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activation for Self-Care Needs in Older Adults With Chronic Kidney Disease: ACTIVE SENIORS With CKD
- ClinicalTrials.gov ID
- NCT06089057
- Acronym / sponsor ID
- NEPH-007-23S
- Conditions
- Lower Extremity Muscle Strength
- Keywords
- mobility
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 29 Sep 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This will be a randomized controlled pilot trial of a 16-week physical activity and power training intervention trial among up to 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. Up to 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Power training and monitored physical activity | Experimental | Behavioral: Pro-social Power training Activity for Aging and Well-being with Chronic Kidney DiseaseThis 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. |
| Attention control | Active comparator | Behavioral: Attention Control for Pro-social Power training Activity for Aging and Well-being with Chronic Kidney DiseaseThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pro-social Power training Activity for Aging and Well-being with Chronic Kidney DiseaseAlso: PACT to AGE WELL with CKDThis 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. | Behavioural | Power training and monitored physical activity |
| Attention Control for Pro-social Power training Activity for Aging and Well-being with Chronic Kidney DiseaseAlso: Attention Control for PACT to AGE WELL with CKDThis 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. | Behavioural | Attention control |
Primary outcome
Feasibility, as measured by the questionnaire, the Feasibility of Intervention Measure
Time frame: 4 months
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
Time frame: 4 months
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
Time frame: 4 months
This will be a qualitative description of potential participants' reasons for declining, if applicable. This will not be aggregated with any other measure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Devika Nair, MD principal investigator
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pro-social Power training Activity for Aging and Well-being with Chronic Kidney Disease in people with Lower Extremity Muscle Strength, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility, as measured by the questionnaire, the Feasibility of Intervention Measure (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.