Stroke
Conditions
Keywords
Stroke, exercise, Behavior Management
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.
Interventions
BEHAVIORALExercise
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.
BEHAVIORALBehavioral 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
University of Florida
North Florida/South Georgia Veterans Health System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
1. -diagnosis of stroke \> six months \< 10 years since stroke onset, 2. \> 18 years; \<90 of age, 3. Montreal Cognitive Assessment - BLIND score \> 19, 4. able to stand from chair and remain standing independently, 5. able to walk 20 feet without physical assistance, 6. no other neurological diagnosis, 7. no history of intermittent claudication, 8. no angina at rest or with minimal exertion, 9. no history of chronic obstructive pulmonary disease, 10. not currently receiving physical rehabilitation services, 11. ability to express pain, fatigue or the need for assistance, 12. ability to follow a three-step command or mimic exercises 13. approval from primary care physician to participate
Exclusion criteria
1. a neurologic condition other than stroke, i.e. Parkinson's Disease, multiple sclerosis, 2. severe, functional limiting arthritis, 3. orthopedic condition that limits mobility, 4. severe weight-bearing pain, 5. current participation in other physical rehabilitation services or exercise programs, 6. 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, 7. 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, 8. use of supplemental oxygen at baseline, 9. severe obstructive pulmonary disease (Classification of Global Initiative for Chronic Obstructive Lung Disease (GOLD) 3 or higher, indicating FEV1\<50% predicted), 10. treatment for pneumonia or lower respiratory infection within the past month, 11. able to run one-quarter mile without stopping; 12. women who are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minutes/week in Moderate to Vigorous Physical Activity | At the end of 2-months of self-managed exercise | Minutes/week in Moderate to Vigorous Physical Activity will be obtained from the Actigraph Activity Monitor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Steps/day | At the end of 2-months of self-managed exercise | Steps/day recorded and stored on the Actigraph Activity Monitor |
| Five Times Sit to Stand | At the end of 2-months of self-managed exercise | Subjects stand up and sit down from a 16" solid seat as quickly as possible 5 times, with their arms folded across their chest. |
| 400 meter walk test | At the end of 2-months of self-managed exercise | 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. |
| Maximum Inspiratory Pressure | At the end of 2-months of self-managed exercise | 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). |
| Maximum Expiratory Pressure | At the end of 2-months of self-managed exercise | 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. |
| Waist circumference | 1. Baseline/pre-intervention, 2. following 6-weeks of therapist-guided exercise, 3. at the end of 2-months of self-managed exercise | Assessed with a tape measure at the level of the umbilicus, above the hip bones at the end of an exhalation |
| Height | Baseline/pre-intervention | Measured from the ground to the horizontal plane of the head |
| Blood Pressure | 1. Baseline/pre-intervention, 2. following 6-weeks of therapist-guided exercise, 3. at the end of 2-months of self-managed exercise | Assessed with a sphygmomanometer according to standard ambulatory protocols. |
Countries
United States
Contacts
CONTACTDorian Rose, PT, MS, PhD
CONTACTJeff Fox, BS, PTA
Outcome results
None listed