An interventional study of Exercise and Behavioral Management Program in Stroke, sponsored by University of Florida. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
Among 23 studies in Stroke by University of Florida — 2 open to participants now, 5 under way, 1 of them phase 3. Stroke · University of Florida.
Among the 23 studies in Stroke by University of Florida, this one is the 8th largest by planned enrollment of the 19 interventional ones, is one of 2 that started in 2026, is one of 10 with no phase, and was the 23rd registered.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 23 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →2 of the 23 studies in Stroke by University of Florida are open now, in 1 country. Each count lists the studies.
Of the 1,415 Stroke studies recruiting now, 697 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.
This study: 18 Years to 89 Years · all sexes · no healthy volunteers.
The full table on the hub →23 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2026.
Median enrollment 14 across the 19 interventional studies, 65 across the 4 observational. Of the 14 that completed or were terminated, 5 (36%) have results posted.
University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
4 of the studies in Stroke by University of Florida that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05047172Phase 3University of FloridaComparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis | 2027-01-31 |
| NCT07563387University of FloridataVNS for Speech and Language Recovery in Aphasia | 2027-01-01 |
| NCT07095920University of FloridaRESPARK - Brain Q for Chronic Stroke | 2027-03 |
| NCT07799987University of FloridaSelf-Managed Exercise in Chronic Stroke | 2027-09-24 |
Among the 23 studies in Stroke by University of Florida, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Phase 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.
Behavioral: Exercise · Behavioral: Behavioral Management Program
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.
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.
Minutes/week in Moderate to Vigorous Physical Activity
Minutes/week in Moderate to Vigorous Physical Activity will be obtained from the Actigraph Activity Monitor.
Time frame: At the end of 2-months of self-managed exercise
Steps/day
Steps/day recorded and stored on the Actigraph Activity Monitor
Time frame: At the end of 2-months of self-managed exercise
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.
Time frame: At the end of 2-months of self-managed exercise
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.
Time frame: At the end of 2-months of self-managed exercise
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).
Time frame: At the end of 2-months of self-managed exercise
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.
Time frame: At the end of 2-months of self-managed exercise
Waist circumference
Assessed with a tape measure at the level of the umbilicus, above the hip bones at the end of an exhalation
Time frame: 1. Baseline/pre-intervention, 2. following 6-weeks of therapist-guided exercise, 3. at the end of 2-months of self-managed exercise
Height
Measured from the ground to the horizontal plane of the head
Time frame: Baseline/pre-intervention
Blood Pressure
Assessed with a sphygmomanometer according to standard ambulatory protocols.
Time frame: 1. Baseline/pre-intervention, 2. following 6-weeks of therapist-guided exercise, 3. at the end of 2-months of self-managed exercise
Plan to share: Yes — De-identified outcome data
Supporting information: Study protocol, Informed consent form
Time frame: Start date will be 1 year after study completion: 9/30/28 End date: 9/30/30
Access criteria: Individuals who contact the PI will be given access to the IPD.
Start is estimated for Sep 2026; primary completion for Sep 2027, 11 months later.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 11 months is below that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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