Self-Managed Exercise in Chronic Stroke

Conditions

• Stroke

Eligibility Criteria

Sex

ALL

Age

18 Years - 89 Years

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

First listed

Sep 2, 2026

Start date

Sep 25, 2026

Status verified

Apr 2026

Primary completion

Sep 24, 2027

Completion

May 30, 2029

Study Design

Enrollment

23 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Exercise
  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.

Primary Outcome Measure

Minutes/week in Moderate to Vigorous Physical Activity [ Time Frame: At the end of 2-months of self-managed exercise ]

Central Contacts

• Dorian Rose, PT, MS, PhD
  (352) 273-8307
  [email protected]
• Jeff Fox, BS, PTA
  (352) 376-1611
  [email protected]

Locations (1)

Find similar trials in Gainesville, FL

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