MultimorbidityNCT06288438
Multicomponent Telerehabilitation to Engage Veterans in Effective Self-Management of Complex Health Conditions
A study testing Motivational Interviewing Techniques, Physical Therapy Interventions and Education in people with Multimorbidity and Physical Deconditioning, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Medically complex older Veterans are at greater risk for progressive declines in physical function, lower quality of life, and increasing care needs. Additionally, older Veterans experience social isolation and loneliness, and have low levels of physical activity. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Multimorbidity, Physical Deconditioning
- What is being tested?
- Motivational Interviewing Techniques, Physical Therapy Interventions and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2024to 31 Mar 2028
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 years of age and older
- Multiple chronic conditions (Functional Comorbidity Index > or = 3)
- Impaired physical function (< or = 8 repetitions on 30 second sit to stand test)
Who cannot join
- Life expectancy < 12 months
- Acute or progressive neurological disorder (e.g. amyotrophic lateral sclerosis, recent stroke)
- Moderate to severe dementia (<11 on telephone Montreal Cognitive Assessment(T-MoCA))
- Medical conditions precluding safe participation in high-intensity rehabilitation (e.g. unstable angina)
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, 1 recruiting
- Recruiting
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211
Jennifer E Stevens-Lapsley, PhD, 303-949-9304, Jennifer.Stevens-Lapsley@va.gov
Jennifer E. Stevens-Lapsley, PhD
About this study
Official title: Multicomponent Telerehabilitation to Engage Veterans in Effective Self-Management of ComplexHealth Conditions
Medically complex older Veterans are at greater risk for progressive declines in physical function, lower quality of life, and increasing care needs. Additionally, older Veterans experience social isolation and loneliness, and have low levels of physical activity. While the Veterans Health Administration has established programs to address rehabilitation needs, these programs tend to be diagnosis-focused, lack self-management approaches, include low-intensity rehabilitation, and typically require in-person attendance. A MultiComponent TeleRehabilitation (MCTR) program that includes high-intensity rehabilitation and self-management interventions, social support, and telehealth and technology supports may be more effective in improving and sustaining physical function for older Veterans with complex health conditions. Therefore, this project is designed to determine whether the MCTR program improves strength and physical function more effectively than traditional interventions.
Read the detailed description
The proposed MultiComponent TeleRehabilitation (MCTR) program addresses current healthcare deficiencies by using a multicomponent approach that includes both high-intensity rehabilitation interventions and self-management interventions that are not part of traditional physical therapy interventions. Therefore, the investigators propose a two-arm, parallel randomized trial using a crossover study design to determine the effectiveness (AIM 1) of a 12-week multicomponent telerehabilitation program to improve physical function. The investigators will also measure Veterans' clinical outcomes to evaluate the effectiveness of the MCTR program to improve physical activity, health self-management, and self-reported health (AIM 2). Lastly, the investigators will explore the effects of the MCTR program on safety events such as emergency room visits, hospitalizations, falls, and other adverse events (AIM 3). Participants (n=126) will be randomized to MCTR or Control group using computer-generated random blocks, stratified by sex. The MCTR group will participate in the 24-week program consisting of 1) progressive, high-intensity rehabilitation, 2) self-management interventions, 3) social support, and 4) technology supports. The 12-week program is split into three phases: the Active Phase (weeks 1-6), the Transition Phase (weeks 7-12), and the Sustainability Phase (weeks 13-24). The Control group will participate in education and health status update sessions in parallel to the MCTR 12-week program. Outcomes will be collected at baseline, 6 weeks, 12 weeks (primary endpoint), and 24 weeks. Achievement of the proposed aims will provide evidence to expand high quality telerehabilitation services for medically complex older Veterans with multiple factors contributing to poor health (e.g., social isolation, loneliness, physical inactivity, poor self-management). Importantly, results will guide the advancement of rehabilitation practices, moving away from a traditionally narrow, episodic, diagnosis-focused approach to a model emphasizing whole health self-management and sustained healthy living. Study findings will have immediate clinical impact as they will be directly translatable to other medically complex and underserved populations who will benefit from innovative telerehabilitation care approaches.
- Conditions
- Multimorbidity, Physical Deconditioning
- Being tested
- Motivational Interviewing Techniques, Physical Therapy Interventions, Education, Health Status Updates, Physical Therapy Consult
- Keywords
- telerehabilitation, high intensity, biobehavioral, social support, physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing TechniquesBehavioural
Motivational Interviewing Techniques including but not limited to open-ended questions, reflection, affirmations, and summary will be used to build participant rapport, support behavior change (physical activity), and facilitate program engagement.
Physical Therapy InterventionsOther
Strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise.
EducationOther
Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene, etc.
Health Status UpdatesOther
Health Status Updates will be completed by a trained assessor. The assessor will ask about adverse events, general health topics, medication changes, and changes in social circumstances.
Physical Therapy ConsultOther
Participants in the control condition will be offered a physical therapy consult at the end of their 24 week study involvement.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent Telerehabilitation Intervention (Group 1) | Experimental | Veterans randomized to the MCTR group will complete the 24-week study intervention consisting of the Active (weeks 1-6), Transition (weeks 7-12), and Sustainability (weeks 13-24) phases. Participants will receive a total of 16 individual sessions (6 integrated, 4 high-intensity rehabilitation, and 6 self-management intervention sessions). Receives: Behavioral: Motivational Interviewing Techniques; Other: Physical Therapy Interventions |
| Education Control (Group 2) | Other | This group will not receive any exercise intervention but will complete 16 sessions with research staff through videoconferencing. These visits will consist of standardized Health Status Update and education sessions on general health topics. Receives: Other: Education; Other: Health Status Updates; Other: Physical Therapy Consult |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 Minute Step Test
This is a functional performance test for aerobic endurance. It requires participants to march in place for 2 minutes (alternating legs), and the score is the number of repetitions completed on the right leg. Scores are continuous, and higher scores indicate better aerobic endurance.
Measured: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Secondary outcomes (14)
Arm Curl Test
This is a functional performance test for upper body strength and is performed on each arm (one arm at a time). It requires the participant to perform as many arm curls (biceps curls) as possible in 30 seconds. Males use a 8 pound weight and females use a 5 pound weight. Scores are continuous, and higher scores indicate greater arm strength (better outcome)
Measured: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
30 Second Sit To Stand
The test uses a standard height chair and requires the participant to stand up and sit down as many times as possible in 30 seconds. More repetitions indicate better lower extremity strength.
Measured: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Physical Activity
Physical activity will be measured via accelerometry and will include an averaged daily step count.
Measured: Will be collected at Baseline, 12 weeks, and 24 weeks.
Exercise readiness to change
Four-item survey collected via interview format, and it is used to categorize participants into stages of change according to the Transtheoretical Model, possible stages include: (pre-contemplating, contemplation, preparation, action, and maintenance).
Measured: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Self-efficacy for Exercise Scale
A 9-item survey, each item is scored on a scale of 0 (not confident) to 10 (very confident) and higher scores indicate greater self-efficacy.
Measured: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Self-efficacy of Managing Chronic Conditions
A 8-item survey rated on a 5-point Likert scale [I am not at all confident (1) to I am very confident (5)], and higher scored indicates better self-efficacy.
Measured: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
The Patient-Specific Functional Scale
This is a questionnaire collected via interview format that quantifies activity or participation limitations that are important to the patient. Each participant identifies 3 activities that are important and that they are currently unable to do or having difficult performing due to their health; each item is then rated on a 0 (unable to preform activity) 0 to 10 (able to perform activity at the same level as before injury or problem) scale. The total score is an average of the 3 activities.
Measured: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Activity Measure for Post-Acute Care (AM-PAC) basic mobility outpatient routine short form
This questionnaire consists of 18 items rated on a 4-point Likert scale in response to the prompt, "How much difficulty do you currently have..." Total scores range from 18 to 72 and higher scores indicate less difficulty with physical tasks.
Measured: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Profile v2.1 (PROPr) survey
This is a 29-item questionnaire, and most items are rated on a 5-point Likert scale. There is one pain intensity item rated on a 0 (no pain) to 10 (worst pain imaginable) scale. Higher scores indicate more of the concept being measured.
Measured: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Patient-Reported Outcomes Measurement Information System (PROMIS) v2 social isolation short form (SF) 8a
An 8-item questionnaire rated on a 1 (never) to 5 (always) Likert scale. Higher scores indicate greater perceptions of loneliness and isolation, which is considered a worse outcome.
Measured: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Patient-Reported Outcomes Measurement Information System (PROMIS) satisfaction with participation in discretionary social activities short form (SF) 7a
Includes 7 items rated on a 1 (not at all) to 5 (very much) Likert scale. Higher scores indicate greater satisfaction with discretionary social activities.
Measured: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Physical Activity and Social Support Scale
A 20 -item survey rated on a scale of 1 (never true) to 7 (always true) that measures emotional, informational, instrumental, validation, and companionship support related to physical activity. Higher scores indicated greater levels of perceived social support.
Measured: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Geriatric Pain Measure
Consists of 22 items scored as yes (1 point) or no (0 points) that assess whether or not a person does or would have pain during activities. There are also 2 items measured on a scale of 0 (no pain) to 10 (worst pain). Total scores range from 0-42 and adjusted scores range from 0-100 with higher scores indicating worse pain.
Measured: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Pain Coping Inventory
This measures both active (transformation, distraction, reducing demands) and passive (retreating, worrying, resting) coping strategies. The inventory includes 34 items rated on a scale from 1 (hardly ever) to 4 (very often). Higher scores indicate more frequent use of each specific coping strategy.
Measured: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start18 Apr 2024
- Primary completion2 Nov 2026 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MultimorbidityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into 1 of 2 groups. Group 1 will receive the intervention for 24 weeks. Group 2 will receive the control condition for 24 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jennifer E. Stevens-Lapsley, PhD, Principal investigator, Rocky Mountain Regional VA Medical Center, Aurora, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288438
- Sponsor's protocol ID
- E5012-R
- Other IDs
- 23-2306
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicomponent Telerehabilitation to Engage Veterans in Effective Self-Management of ComplexHealth Conditions
- ClinicalTrials.gov ID
- NCT06288438
- Acronym / sponsor ID
- E5012-R
- Conditions
- Multimorbidity, Physical Deconditioning
- Keywords
- telerehabilitation, high intensity, biobehavioral, social support, physical activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 2 Nov 2026 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 1 Mar 2024 (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.
Medically complex older Veterans are at greater risk for progressive declines in physical function, lower quality of life, and increasing care needs. Additionally, older Veterans experience social isolation and loneliness, and have low levels of physical activity. While the Veterans Health Administration has established programs to address rehabilitation needs, these programs tend to be diagnosis-focused, lack self-management approaches, include low-intensity rehabilitation, and typically require in-person attendance. A MultiComponent TeleRehabilitation (MCTR) program that includes high-intensity rehabilitation and self-management interventions, social support, and telehealth and technology supports may be more effective in improving and sustaining physical function for older Veterans with complex health conditions. Therefore, this project is designed to determine whether the MCTR program improves strength and physical function more effectively than traditional interventions.
Detailed description
The proposed MultiComponent TeleRehabilitation (MCTR) program addresses current healthcare deficiencies by using a multicomponent approach that includes both high-intensity rehabilitation interventions and self-management interventions that are not part of traditional physical therapy interventions. Therefore, the investigators propose a two-arm, parallel randomized trial using a crossover study design to determine the effectiveness (AIM 1) of a 12-week multicomponent telerehabilitation program to improve physical function. The investigators will also measure Veterans' clinical outcomes to evaluate the effectiveness of the MCTR program to improve physical activity, health self-management, and self-reported health (AIM 2). Lastly, the investigators will explore the effects of the MCTR program on safety events such as emergency room visits, hospitalizations, falls, and other adverse events (AIM 3). Participants (n=126) will be randomized to MCTR or Control group using computer-generated random blocks, stratified by sex. The MCTR group will participate in the 24-week program consisting of 1) progressive, high-intensity rehabilitation, 2) self-management interventions, 3) social support, and 4) technology supports. The 12-week program is split into three phases: the Active Phase (weeks 1-6), the Transition Phase (weeks 7-12), and the Sustainability Phase (weeks 13-24). The Control group will participate in education and health status update sessions in parallel to the MCTR 12-week program. Outcomes will be collected at baseline, 6 weeks, 12 weeks (primary endpoint), and 24 weeks. Achievement of the proposed aims will provide evidence to expand high quality telerehabilitation services for medically complex older Veterans with multiple factors contributing to poor health (e.g., social isolation, loneliness, physical inactivity, poor self-management). Importantly, results will guide the advancement of rehabilitation practices, moving away from a traditionally narrow, episodic, diagnosis-focused approach to a model emphasizing whole health self-management and sustained healthy living. Study findings will have immediate clinical impact as they will be directly translatable to other medically complex and underserved populations who will benefit from innovative telerehabilitation care approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into 1 of 2 groups. Group 1 will receive the intervention for 24 weeks. Group 2 will receive the control condition for 24 weeks.
| Arm | Type | Receives |
|---|---|---|
| Multicomponent Telerehabilitation Intervention (Group 1) | Experimental | Behavioral: Motivational Interviewing Techniques, Other: Physical Therapy InterventionsVeterans randomized to the MCTR group will complete the 24-week study intervention consisting of the Active (weeks 1-6), Transition (weeks 7-12), and Sustainability (weeks 13-24) phases. Participants will receive a total of 16 individual sessions (6 integrated, 4 high-intensity rehabilitation, and 6 self-management intervention sessions). |
| Education Control (Group 2) | Other | Other: Education, Other: Health Status Updates, Other: Physical Therapy ConsultThis group will not receive any exercise intervention but will complete 16 sessions with research staff through videoconferencing. These visits will consist of standardized Health Status Update and education sessions on general health topics. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 60 years of age and older
- Multiple chronic conditions (Functional Comorbidity Index > or = 3)
- Impaired physical function (< or = 8 repetitions on 30 second sit to stand test)
Key exclusion criteria (4 listed)
- Life expectancy < 12 months
- Acute or progressive neurological disorder (e.g. amyotrophic lateral sclerosis, recent stroke)
- Moderate to severe dementia (<11 on telephone Montreal Cognitive Assessment(T-MoCA))
- Medical conditions precluding safe participation in high-intensity rehabilitation (e.g. unstable angina)
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 |
|---|---|---|
| Motivational Interviewing TechniquesMotivational Interviewing Techniques including but not limited to open-ended questions, reflection, affirmations, and summary will be used to build participant rapport, support behavior change (physical activity), and facilitate program engagement. | Behavioural | Multicomponent Telerehabilitation Intervention (Group 1) |
| Physical Therapy InterventionsStrengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise. | Other | Multicomponent Telerehabilitation Intervention (Group 1) |
| EducationEducation on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene, etc. | Other | Education Control (Group 2) |
| Health Status UpdatesHealth Status Updates will be completed by a trained assessor. The assessor will ask about adverse events, general health topics, medication changes, and changes in social circumstances. | Other | Education Control (Group 2) |
| Physical Therapy ConsultParticipants in the control condition will be offered a physical therapy consult at the end of their 24 week study involvement. | Other | Education Control (Group 2) |
Primary outcome
2 Minute Step Test
Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
This is a functional performance test for aerobic endurance. It requires participants to march in place for 2 minutes (alternating legs), and the score is the number of repetitions completed on the right leg. Scores are continuous, and higher scores indicate better aerobic endurance.
14 secondary outcomes
Arm Curl Test
Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
30 Second Sit To Stand
Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Physical Activity
Time frame: Will be collected at Baseline, 12 weeks, and 24 weeks.
Exercise readiness to change
Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Self-efficacy for Exercise Scale
Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Self-efficacy of Managing Chronic Conditions
Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
The Patient-Specific Functional Scale
Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Activity Measure for Post-Acute Care (AM-PAC) basic mobility outpatient routine short form
Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Patient-Reported Outcomes Measurement Information System (PROMIS) 29+2 Profile v2.1 (PROPr) survey
Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Patient-Reported Outcomes Measurement Information System (PROMIS) v2 social isolation short form (SF) 8a
Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Patient-Reported Outcomes Measurement Information System (PROMIS) satisfaction with participation in discretionary social activities short form (SF) 7a
Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Physical Activity and Social Support Scale
Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Geriatric Pain Measure
Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
Pain Coping Inventory
Time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.
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 24 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Multimorbidity
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Preoperative Multimorbidity and Functional Recovery After Total Knee Arthroplasty
Knee Osteoarthritis, Multimorbidity
Active, not recruiting
Optimizing Prescribing Decisions for Hospitalized Older Adults With Chronic Conditions
Prescribing Decisions, Diabetes
RecruitingObservational study
How Complexity and Multiple Illnesses Affect Hospitalized Patients' Health: A Multicenter Study
Multimorbidities
Not yet recruiting
Cardiovascular Disease Multimorbidity
Cardiovascular Diseases
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.
Jennifer E. Stevens-Lapsley, PhD principal investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing Techniques, Physical Therapy Interventions and Education in people with Multimorbidity and Physical Deconditioning, 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 24 Feb 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?
Contact Jennifer E Stevens-Lapsley, PhD ((303) 949-9304, Jennifer.Stevens-Lapsley@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 Minute Step Test (time frame: Change from baseline to 6 weeks, 12 weeks, and 24 weeks compared to the control group.). 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 24 Feb 2026.