Enhancing Resilience in Young Stroke Survivors With Res-ET

NCT05348044 | Completed

• 1 other identifier: IRB_00150247
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Resilience; Stroke

Keywords

IMST; Young Stroke Survivor; Resilience; At-home program

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Demographic variables

  12 months

• Assess the efficacy potential of Res-ET intervention on resilience measured by UW Resilience Scale.

  12 months

• Assess the efficacy potential of Res-ET intervention on Physiological changes in young stroke survivors pre/post Res-ET intervention.

  12 months

• Assess the efficacy potential of Res-ET intervention on Psychosocial changes in young stroke survivors pre/post Res-ET intervention.

  12 months

• Qualitative assessment of Res-ET

  12 months

Study Arms (1)

Res-ET intervention

EXPERIMENTAL

Res-ET will include a 6-week remote (Zoom) home-group-delivered IMST exercise intervention of approximately 20 minutes a session consisting of a warmup and 3 bouts of 5 sets x 6 inspiratory maneuvers using an IMST training device (POWERBreathe) and 1 min recovery between each set (inspiration to rest ratio taken from Craighead 2021). The intensity of the IMST maneuvers will begin at 40% of MIP during week one, 50% of MIP during week two, and 60% of MIP during weeks three through six. Participants will remotely perform Res-ET intervention 4 times per week in a group setting (Zoom). During the intervention multiple opportunities to engage in a group training session will be available and a recording of an IMST session will be available for viewing if the participant is unable to attend a live group session. Each week the CEP will record participation rates and accelerometry data in REDcap. Group conversations and motivation will be encouraged during live training sessions.

Other: Res-ET intervention

Interventions

Res-ET intervention OTHER

Remote IMST delivery on Resilience

Res-ET intervention

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Community-dwelling.
• 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
• Must obtain medical clearance to perform IMST training.
• Must be able to perform Res-ET intervention without the aid of a caregiver.
• Must have access to a communication device (phone, tablet, computer) and have internet access.

You may not qualify if:

• Do not receive medical clearance from their physician
• Have COPD greater than stage 1, or intermittent asthma.
• Currently pregnant. If a participant becomes pregnant during the intervention they may remain in the intervention or withdraw.
• Have congestive heart failure, unstable arrhythmias, or other conditions where IMST is contraindicated by physician

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Department of Occupational & Recreational Therapies

Salt Lake City, Utah, 84108, United States

Location

Related Publications (31)

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MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: The proposed feasibility study is a rolling enrollment mixed-methods, one-group quasi-experimental design.

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: April 27, 2022
• Study Start: May 5, 2022
• Primary Completion: January 5, 2023
• Study Completion: January 10, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)