Malcom Randall VAMC
Gainesville, Florida, 32608, United States
Location contact
Dorian Rose, PT, MS, PhD
CONTACT
Dorian Rose, PT, MS, PhD
PRINCIPAL_INVESTIGATOR
Jeff Fox, BS, PTA
CONTACT
(352) 376-1611 ext. 102033
NCT Number: NCT07799987
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.
Trial opening soon.
Get Notified18 year–89 year
All sexes
Interventional
Not applicable
Gainesville, Florida, 32608, United States
Dorian Rose, PT, MS, PhD
CONTACT
Dorian Rose, PT, MS, PhD
PRINCIPAL_INVESTIGATOR
Jeff Fox, BS, PTA
CONTACT
(352) 376-1611 ext. 102033
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: At the end of 2-months of self-managed exercise
Steps/day recorded and stored on the Actigraph Activity Monitor
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
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
Assessed with a tape measure at the level of the umbilicus, above the hip bones at the end of an exhalation
Time frame: Baseline/pre-intervention
Measured from the ground to the horizontal plane of the head
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
Assessed with a sphygmomanometer according to standard ambulatory protocols.
Contact information is provided by the study sponsor or research team.
University of Florida
Other
Feasibility and Adherence to Self-Managed Exercise to Maintain Health in Chronic Stroke: A Pilot Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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