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StrokeNCT07799987

Self-Managed Exercise in Chronic Stroke

A study testing Exercise and Behavioral Management Program in people with Stroke, run by University of Florida at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This pilot study will assess the feasibility of a novel intervention to promote long-term self-managed exercise for post-stroke community-dwelling individuals. We will test a multi-disciplinary intervention that includes Behavioral Management as an adjuvant to exercise on the ability of post-stroke community-dwelling… Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Stroke
What is being tested?
Exercise and Behavioral Management Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
25 Sep 2026to 30 May 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 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -diagnosis of stroke > six months < 10 years since stroke onset,
  • > 18 years; <90 of age,
  • Montreal Cognitive Assessment - BLIND score > 19,
  • able to stand from chair and remain standing independently,
  • able to walk 20 feet without physical assistance,
  • no other neurological diagnosis,
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  • no history of intermittent claudication,
  • no angina at rest or with minimal exertion,
  • no history of chronic obstructive pulmonary disease,
  • not currently receiving physical rehabilitation services,
  • ability to express pain, fatigue or the need for assistance,
  • ability to follow a three-step command or mimic exercises
  • approval from primary care physician to participate

Who cannot join

  • a neurologic condition other than stroke, i.e. Parkinson's Disease, multiple sclerosis,
  • severe, functional limiting arthritis,
  • orthopedic condition that limits mobility,
  • severe weight-bearing pain,
  • current participation in other physical rehabilitation services or exercise programs,
  • Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within the past year, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living). Anyone meeting New York Heart Association criteria for Class 3 or Class 4 heart disease will be excluded,
Show all 12Show fewer
  • Severe hypertension: with systolic > 200 mmHg and diastolic > 110 mmHg at rest, that cannot be medically controlled into the resting range of 180/100 mmHg,
  • use of supplemental oxygen at baseline,
  • severe obstructive pulmonary disease (Classification of Global Initiative for Chronic Obstructive Lung Disease (GOLD) 3 or higher, indicating FEV1<50% predicted),
  • treatment for pneumonia or lower respiratory infection within the past month,
  • able to run one-quarter mile without stopping;
  • women who are pregnant

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dorian Rose, PT, MS, PhD contact

(352) 273-8307

dkrose@phhp.ufl.edu

Jeff Fox, BS, PTA contact

(352) 376-1611 ext. 102033

jdfox@ufl.edu

United States1 site

  • Malcom Randall VAMC

    Gainesville, Florida, 32608

    Dorian Rose, PT, MS, PhD, 352-273-8307, dkrose@phhp.ufl.edu

    Jeff Fox, BS, PTA, (352) 376-1611 ext. 102033, jdfox@ufl.edu

Other trials in United States

About this study

Official title: Feasibility and Adherence to Self-Managed Exercise to Maintain Health in Chronic Stroke: A Pilot Study

This pilot study will assess the feasibility of a novel intervention to promote long-term self-managed exercise for post-stroke community-dwelling individuals. We will test a multi-disciplinary intervention that includes Behavioral Management as an adjuvant to exercise on the ability of post-stroke community-dwelling individuals to self-manage sustained Physical Activity. In Phase I, participants will engage in a clinician-led 18-session in-home intervention of respiratory, strengthening and cardiovascular exercise and a weekly 1-hour virtual Behavioral Management Program of motivational interviewing and goal setting related to participants' Phase I exercise program. A waist-worn sensor will provide minutes/day in activity and sedentary behavior. Phase II will begin following the 18-session guided program. Participants will be followed for two-months with weekly check-ins of behavioral management program and for exercise progression. Participants will continue to wear the activity monitor with the goal to independently attain 150 minutes of Moderate to Vigorous Physical Activity/week. This proposed Behavioral Management Program (BMP) + Exercise Program (EP) package has the potential to decrease cardiovascular risk and secondary stroke in those living with chronic stroke. The expected outcome of this proposal will provide an evidence-based intervention to sustain the health of those living with post-stroke disability. The impact of this proposal may have far-reaching effects; this multi-disciplinary program could readily be adapted for others living with a chronic illness to ensure optimal health and quality of life in the presence of physical disability.

Conditions
Stroke
Being tested
Exercise, Behavioral Management Program
Keywords
Stroke, exercise, Behavior Management
Medical subject headings
Stroke, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseBehavioural

    1. Respiratory Muscle Training (RMT): Participants will complete inspiratory and expiratory muscle training with a respiratory training device containing an adjustable-tension spring for resistance. Five sets of 5 maximal volume and speed breaths for both inspiration and expiration will be completed each session, starting each at approximately 25% of the maximal pressure recorded at baseline Assessment A.
    2. Strengthening Exercise: The upper and lower extremity exercises will use body weight as resistance or resistance bands and will be based on our previous successful implementation of a home-based strengthening program.41 For each exercise, participants will begin such that they are able to perform the movement with appropriate kinematics, without substitution.
    3. Cardiovascular Exercise: Example exercises include alternating hip flexion, sit to stand, marching in place, step-ups, seated cycling with Exercycle, and gait.

  • Behavioral Management ProgramBehavioural

    Conducted virtually, separate from the Exercise Program each 1-hour session will consist of motivational interviewing and goal setting related to participants' Phase I exercise program. Motivational interviewing will center around categories of motivation, environmental support, problem solving and current and past activity level. The research team will use motivational interviewing to document barriers to weekly goal achievement using the psychosocial, health, sociodemographic and environmental domains. Structured interview questions will cover barriers to achieving weekly exercise goals. Goal-setting will utilize the Likert-based Goal Attainment Scale, a person-centered approach to setting objective, measurable goals. In GAS, tasks are individually identified to suit the participant, and the levels are individually set around their current and expected levels of performance. Participants will rate their degree of attainment on their self-determined goal for the week.

Study groups in NCT07799987
Study groupRoleWhat they receive
ExerciseExperimentalPhase I Exercise Program: All study participants will engage in an in-home 18-session, 1-hour intervention of respiratory, strengthening and cardiovascular exercise. The Exercise Program will be personalized to each participant's ability level. Phase I Behavioral Management Program (BMP): Conducted virtually, separate from the Exercise Program each 1-hour session will consist of motivational interviewing and goal setting related to participants' Phase I exercise program. Motivational interviewing will center around categories of motivation, environmental support, problem solving and current and past activity level. Phase II: Self-managed Physical Activity: Phase II will begin following Assessment B (Phase I post-test) and continue for 2 months. In Phase II, the goal is for participants to attain 150 minutes of MVPA/week. Participants were instructed in and provided exercise options to attain that level of activity during Phase I.
Receives: Behavioral: Exercise; Behavioral: Behavioral Management Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Minutes/week in Moderate to Vigorous Physical Activity

    Minutes/week in Moderate to Vigorous Physical Activity will be obtained from the Actigraph Activity Monitor.

    Measured: At the end of 2-months of self-managed exercise

Secondary outcomes (8)

  1. Steps/day

    Steps/day recorded and stored on the Actigraph Activity Monitor

    Measured: At the end of 2-months of self-managed exercise

  2. Five Times Sit to Stand

    Subjects stand up and sit down from a 16" solid seat as quickly as possible 5 times, with their arms folded across their chest.

    Measured: At the end of 2-months of self-managed exercise

  3. 400 meter walk test

    Participants walk at their usual walking pace for 400 meters and the time to complete is recorded. Participants are allowed to stop and stand to rest and may use an assistive device. This test evaluates cardiorespiratory fitness and mobility, and predicts health outcomes like disability or mortality in older adults.

    Measured: At the end of 2-months of self-managed exercise

  4. Maximum Inspiratory Pressure

    Subjects will perform a seated MIP maneuver (using a Respiratory Pressure Manometer) from residual volume, in accordance with American Thoracic Society testing guidelines for respiratory muscle testing. Trials will be repeated every 1-2 minutes until <10% variability is achieved between three trials (typically achieved within 4-6 trials).

    Measured: At the end of 2-months of self-managed exercise

  5. Maximum Expiratory Pressure

    Subjects will complete a seated MEP maneuver from total lung capacity as per American Thoracic Society guidelines. Trials will be repeated every 1-2 minutes until 3 measurements with <10% variability are achieved.

    Measured: At the end of 2-months of self-managed exercise

  6. Waist circumference

    Assessed with a tape measure at the level of the umbilicus, above the hip bones at the end of an exhalation

    Measured: 1. Baseline/pre-intervention, 2. following 6-weeks of therapist-guided exercise, 3. at the end of 2-months of self-managed exercise

  7. Height

    Measured from the ground to the horizontal plane of the head

    Measured: Baseline/pre-intervention

  8. Blood Pressure

    Assessed with a sphygmomanometer according to standard ambulatory protocols.

    Measured: 1. Baseline/pre-intervention, 2. following 6-weeks of therapist-guided exercise, 3. at the end of 2-months of self-managed exercise

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2026
  2. Study start25 Sep 2026 (estimated)
  3. Primary completion24 Sep 2027 (estimated)
  4. Study completion30 May 2029 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07799987
Sponsor's protocol ID
IRB202600051
Other IDs
1225RRDT-BRRC-01
Status last verified
Apr 2026
First submitted
24 Aug 2026
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified outcome data

Publications

  • Grant M, Ponsford J. Goal attainment scaling in brain injury rehabilitation: strengths, limitations and recommendations for future applications. Neuropsychol Rehabil. 2014;24(5):661-77. doi: 10.1080/09602011.2014.901228. Epub 2014 May 1.

    PubMed 24787703

  • Waid-Ebbs JK; BCBA-D; Daly J, Wu SS, Berg WK, Bauer RM, Perlstein WM, Crosson B. Response to goal management training in veterans with blast-related mild traumatic brain injury. J Rehabil Res Dev. 2014;51(10):1555-66. doi: 10.1682/JRRD.2013.12.0266.

    PubMed 25860148

  • Furie KL, Kasner SE, Adams RJ, Albers GW, Bush RL, Fagan SC, Halperin JL, Johnston SC, Katzan I, Kernan WN, Mitchell PH, Ovbiagele B, Palesch YY, Sacco RL, Schwamm LH, Wassertheil-Smoller S, Turan TN, Wentworth D; American Heart Association Stroke Council, Council on Cardiovascular Nursing, Council on Clinical Cardiology, and Interdisciplinary Council on Quality of Care and Outcomes Research. Guidelines for the prevention of stroke in patients with stroke or transient ischemic attack: a guideline for healthcare professionals from the american heart association/american stroke association. Stroke. 2011 Jan;42(1):227-76. doi: 10.1161/STR.0b013e3181f7d043. Epub 2010 Oct 21.

    PubMed 20966421

  • Rose DK, Schafer J, Conroy C. Extending the continuum of care poststroke: creating a partnership to provide a community-based wellness program. J Neurol Phys Ther. 2013 Jun;37(2):78-84. doi: 10.1097/NPT.0b013e3182941c37.

    PubMed 23703370

  • Billinger SA, Arena R, Bernhardt J, Eng JJ, Franklin BA, Johnson CM, MacKay-Lyons M, Macko RF, Mead GE, Roth EJ, Shaughnessy M, Tang A; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Lifestyle and Cardiometabolic Health; Council on Epidemiology and Prevention; Council on Clinical Cardiology. Physical activity and exercise recommendations for stroke survivors: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Aug;45(8):2532-53. doi: 10.1161/STR.0000000000000022. Epub 2014 May 20.

    PubMed 24846875

  • Mahmood A, Nayak P, Deshmukh A, English C, N M, Solomon M J, B U. Measurement, determinants, barriers, and interventions for exercise adherence: A scoping review. J Bodyw Mov Ther. 2023 Jan;33:95-105. doi: 10.1016/j.jbmt.2022.09.014. Epub 2022 Sep 26.

    PubMed 36775533

  • Fini NA, Bernhardt J, Churilov L, Clark R, Holland AE. A 2-Year Longitudinal Study of Physical Activity and Cardiovascular Risk in Survivors of Stroke. Phys Ther. 2021 Feb 4;101(2):pzaa205. doi: 10.1093/ptj/pzaa205.

    PubMed 33305804

Questions about this trial

What is this clinical trial studying?

A study testing Exercise and Behavioral Management Program in people with Stroke, run by University of Florida 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 13 inclusion and 12 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: opening soon, as of the sponsor's last update on 2 Sep 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 Dorian Rose, PT, MS, PhD ((352) 273-8307, dkrose@phhp.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Minutes/week in Moderate to Vigorous Physical Activity (time frame: At the end of 2-months of self-managed exercise). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07799987, which also lists 7 linked publications.

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 2 Sep 2026.

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Self-Managed Exercise in Chronic Stroke (NCT07799987) | AzTrials