Self-Managed Exercise in Chronic Stroke
NCT07799987 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2026-09-02
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
Interventions
- BEHAVIORAL
-
Exercise
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
-
Behavioral Management Program
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.
Sponsors & Collaborators
-
North Florida/South Georgia Veterans Health System
collaborator OTHER - lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 89 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-25
- Primary Completion
- 2027-09-24
- Completion
- 2029-05-30
Countries
- United States
Study Locations
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