Res-ET intervention for Stroke

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Department of Occupational & Recreational Therapies, Salt Lake City, UT
Stroke+1 More
Res-ET intervention - Other
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

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

Eligible Conditions

  • Stroke
  • Resilience

Treatment Effectiveness

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: 12 months

12 months
Assess the efficacy potential of Res-ET intervention on Physiological changes in young stroke survivors pre/post Res-ET intervention.
Assess the efficacy potential of Res-ET intervention on Psychosocial changes in young stroke survivors pre/post Res-ET intervention.
Assess the efficacy potential of Res-ET intervention on resilience measured by UW Resilience Scale.
Demographic variables
Feasibility of Res-ET intervention acceptability and adherence
Feasibility of Res-ET intervention recruitment and retention
Qualitative assessment of Res-ET

Trial Safety

Trial Design

1 Treatment Group

Res-ET intervention
1 of 1
Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Res-ET intervention · No Placebo Group · N/A

Res-ET intervention
Other
Experimental Group · 1 Intervention: Res-ET intervention · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
Closest Location: Department of Occupational & Recreational Therapies · Salt Lake City, UT
Photo of Salt Lake City 1Photo of Salt Lake City 2Photo of Salt Lake City 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Stroke
0 CompletedClinical Trials

Who is running the clinical trial?

University of UtahLead Sponsor
976 Previous Clinical Trials
1,765,489 Total Patients Enrolled
16 Trials studying Stroke
2,318 Patients Enrolled for Stroke

Eligibility Criteria

Age 18 - 65 · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must have access to a communication device (phone, tablet, computer) and have internet access.
You have had a stroke between the age of 18 and 50 years of age
You must be able to perform Res-ET without the aid of a caregiver.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References