Stroke Clinical Trial
Official title:
Feasibility Study to Increase Resilience Through an At-home Virtual Exercise Training (Res-ET) Intervention Using Inspiratory Muscle Strength Training (IMST)
Verified date | April 2023 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The proposed pilot study will explore the feasibility and preliminary impacts of a 6-week at-home group delivered inspiratory muscle strength training (IMST) exercise intervention on resilience in young stroke survivors. Resilience Exercise Training (Res-ET) intervention on young stroke survivors will assess feasibility of Res-ET and preliminary changes in resilience on young stroke survivors using a quasi-experimental one-group pretest-posttest design within the RE-AIM framework. The connection between resilience and exercise has not been clearly identified in literature, and there is no literature supporting IMST on resilience in young stroke survivors. The Res-ET intervention in young stroke survivors may serve as a pragmatic and novel approach to increase resilience while also increasing physiological and psychosocial well-being of young stroke survivors. Aim 1. Test the feasibility (recruitment, retention, participation, and acceptability) of Res-ET intervention in a sample of young stroke survivors having had a stroke between the age of 18 - 50, AND who experienced a stroke within the last 6 months to 55 years of age AND have been cleared by a physician to participate in IMST exercise. Aim 2. Assess the efficacy potential of Res-ET intervention on resilience, and preliminary direction and magnitude of psychosocial and physiological outcomes in young stroke survivors pre/post Res-ET intervention. Psychosocial outcome measures consist of; positive affect, self-efficacy, meaning/purpose, physical function, fatigue, and social satisfaction. Physiological outcome measures consist of, pulmonary function, physical activity, biometrics, and daily movement. Aim 3. Collect qualitative data to assess acceptability and usability of Res-ET. Data will be collected through interviews and questionnaires about Res-ET feasibility, perceived utility, and satisfaction of the intervention. Perceived changes to resilience, functional capacity/movement (ADL's), and well-being will be recorded, transcribed, and thematically coded
Status | Completed |
Enrollment | 19 |
Est. completion date | January 10, 2023 |
Est. primary completion date | January 5, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: 1. Community-dwelling. 2. Had a stroke between the age of 18 and 50 years of age. Stroke occurred more than 6 months ago and is currently less than 55 years of age 3. Must obtain medical clearance to perform IMST training. 4. Must be able to perform Res-ET intervention without the aid of a caregiver. 5. Must have access to a communication device (phone, tablet, computer) and have internet access. Exclusion Criteria: 1. Do not receive medical clearance from their physician 2. Have COPD greater than stage 1, or intermittent asthma. 3. Currently pregnant. If a participant becomes pregnant during the intervention they may remain in the intervention or withdraw. 4. Have congestive heart failure, unstable arrhythmias, or other conditions where IMST is contraindicated by physician |
Country | Name | City | State |
---|---|---|---|
United States | Department of Occupational & Recreational Therapies | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah |
United States,
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* Note: There are 31 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of Res-ET intervention recruitment and retention | Feasibility will be assessed by Recruitment and Adherence measures, recruit-ability (20 participants in 6 months) and retention (retain 80% of enrolled participants) | 12 months | |
Primary | Feasibility of Res-ET intervention acceptability and adherence | To assess adherence and acceptability feasibility of remote-home-group delivery, IMST training device, and use of wearable technology for intervention fidelity and tracking (80% intervention adherence and 90% accelerometry data acquisition) mean and standard deviation (SD) of scores on the Likert scales will be calculated in an expression of percentage of response. | 12 months | |
Secondary | Demographic variables | Summary Statistics | 12 months | |
Secondary | Assess the efficacy potential of Res-ET intervention on resilience measured by UW Resilience Scale. | Paired t-tests from pre- to post-intervention will be used to determine the direction and magnitude of changes in young stroke survivors for resilience outcome measures.
Significance will be assessed at the 0.05 level, mean, standard deviation, normality, standard error of measurement and minimal clinically important differences will be calculated. Bonferroni correction will be used to control for type 1 error via a post hoc pairwise analysis. |
12 months | |
Secondary | Assess the efficacy potential of Res-ET intervention on Physiological changes in young stroke survivors pre/post Res-ET intervention. | Paired t-tests from pre- to post-intervention will be used to determine the direction and magnitude of changes in young stroke survivors for physiological measures (blood pressure, pulmonary function, HRV, SPAQ, MIP, Body weight and composition).
Significance will be assessed at the 0.05 level, mean, standard deviation, normality, standard error of measurement and minimal clinically important differences will be calculated. Bonferroni correction will be used to control for type 1 error via a post hoc pairwise analysis. |
12 months | |
Secondary | Assess the efficacy potential of Res-ET intervention on Psychosocial changes in young stroke survivors pre/post Res-ET intervention. | Paired t-tests from pre- to post-intervention will be used to determine the direction and magnitude of changes in young stroke survivors for psychosocial measures (SIS, fatigue, self-efficacy, positive affect and well-being).
Significance will be assessed at the 0.05 level, mean, standard deviation, normality, standard error of measurement and minimal clinically important differences will be calculated. Bonferroni correction will be used to control for type 1 error via a post hoc pairwise analysis. |
12 months | |
Secondary | Qualitative assessment of Res-ET | The qualitative analysis will employ participant driven response, through open ended questions that will enable the participant to share personal experiences and perspectives around acceptability and usability of the Res-ET intervention. To assist in creating a sound qualitative analysis the consolidated criteria for reporting of qualitative research (COREQ) will guide the qualitative reporting, methods, and results. COREQ as presented by Tong and colleagues (2007) is a comprehensive reporting design for qualitative studies, which is a 32-item checklist for interviews and focus groups broken into three domains, (1) research team and reflexivity, (2) study design, and (3) analysis and findings. | 12 months |
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