Self-Managed Exercise in Chronic Stroke

NCT07799987 | Not Yet Recruiting

• 2 other identifiers: IRB2026000511225RRDT-BRRC-01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Stroke; exercise; Behavior Management

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (8)

• Steps/day

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

• Five Times Sit to Stand

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

• 400 meter walk test

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

• Maximum Inspiratory Pressure

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

• Maximum Expiratory Pressure

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

Study Arms (1)

Exercise

EXPERIMENTAL

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

Interventions

Exercise BEHAVIORAL

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.

Exercise

Behavioral Management Program BEHAVIORAL

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.

Exercise

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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

You may not qualify if:

• 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,
• 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

Sponsors & Collaborators

• University of Florida: lead
• North Florida/South Georgia Veterans Health System: collaborator

Study Sites (1)

Malcom Randall VAMC

Gainesville, Florida, 32608, United States

Location

Related Publications (7)

• 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.

  PMID: 24787703 BACKGROUND

• 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.

  PMID: 25860148 BACKGROUND

• 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.

  PMID: 20966421 BACKGROUND

• 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.

  PMID: 23703370 BACKGROUND

• 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.

  PMID: 24846875 BACKGROUND

• 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.

  PMID: 36775533 BACKGROUND

• 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.

  PMID: 33305804 BACKGROUND

MeSH Terms

Conditions

Stroke; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Dorian Rose, PT, MS, PhD

CONTACT

(352) 273-8307; dkrose@phhp.ufl.edu

Jeff Fox, BS, PTA

CONTACT

(352) 376-1611; jdfox@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 2, 2026
• Study Start: September 25, 2026
• Primary Completion (Estimated): September 24, 2027
• Study Completion (Estimated): May 30, 2029
• Last Updated: September 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.

Locations

US (1)