Clinical trial NCT05348044: Enhancing Resilience in Young Stroke Survivors With Res-ET
Official title: Feasibility Study to Increase Resilience Through an At-home Virtual Exercise Training (Res-ET) Intervention Using Inspiratory Muscle Strength Training (IMST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resilience
Stroke
Keywords: IMST
Young Stroke Survivor
Resilience
At-home program
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The proposed feasibility study is a rolling enrollment mixed-methods, one-group quasi-experimental design.
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: Strokes impact a growing number of younger individuals; it has been reported that approximately 10 to15% of all strokes occur in individuals 18 to 50 years of age with hospitalization rates almost doubling from 1995 to 2012. Disability or the onset of a chronic condition like stroke is often life-altering and this might be exaggerated in persons who have a stroke at a younger age at the height of managing family and work responsibilities. The FUTURE study reports after a 13.9 year follow up that 44.7% of young stroke patients have poor functional outcomes. Young stroke survivors may encounter lifelong challenges impacting physical, emotional, visual, and cognitive capabilities. Edwards and colleagues (2019) reported young stroke survivors with no early recurrence showed a 7-fold increased hazard ratio of long-term risk of adverse outcomes when compared to young healthy controls. Post-stroke depression affects approximately one third of all stroke survivors and young stroke survivors are nearly three times more likely to have anxiety and depression. Current focus in rehabilitation is on acute physical and neurological function and integration, but this focus may not necessarily lead to positive long-term outcomes for young stroke survivors.

Resilience is the inherent and acquired ability to recover and sustain a new way of thriving after a life altering event or situation. Resilience has been shown to be dependent on inherent and acquired factors that have both modifiable and non-modifiable components. Understanding the relationship between resilience and disability is still new but it appears increased resilience may mitigate secondary symptoms such as pain or fatigue, may predict physical functioning, is positively associated to self-efficacy, optimism, and improved quality of life. According to Terrill et al.'s (2019) Resilience and Disability model, resilience is dependent on intrapersonal, social-environmental, and interpersonal factors that dynamically influence an individual's capacity to achieve and maintain quality of life and well-being. Interactional aspects of intrapersonal and environmental factors influence relationships, systems of support, and combine to create an ecosystem for resilience and well-being. Increasing/modifying psychosocial components related to intrapersonal, intrapersonal, and environmental factors have been shown to increase resilience such as; self-efficacy, positive affect, positive psychological well-being, meaning and purpose, and engagement with social environment.

Exercise may be a potential mechanism for enhancing resilience. For example, Childs and Wit (2014) found that regular exercise is associated with psychosocial factors like emotional resilience to acute stress in healthy adults and Deuster and Silverman (2013) proposed a conceptual model where increased levels of fitness link to increased resilience. Evidence also suggests that exercise need not be intensely physically demanding to enhance mental and emotional health. The positive effects of low-intensity physical movement programs on resilience have not been examined in the young stroke survivors. Exercise has been significantly associated with improved self-reported mental health and preliminary findings demonstrated exercise improves mental health outcomes after stroke, but empirical studies examining these effects are still largely lacking, especially in young stroke survivors who are at greater risk of depression and distress.

Exercise is a commonly prescribed treatment post-stroke, and benefits derived through exercise may parallel those identified in the Resilience and Disability model. Exercise interventions have the potential to positively influence multiple psychological, physical, and psychosocial domains after stroke. Exercise is typically defined as any bodily movement produced by skeletal muscles that results in energy expenditure, and is planned, structured, and repetitive with a final or an intermediate objective of improvement or maintenance of physical fitness. There is strong evidence that exercise after stroke can improve cardiovascular fitness, walking ability, and upper-extremity muscle strength. There is also evidence that exercise has positive effects on depression and cognition in adults without stroke, and preliminary findings demonstrate that exercise may confer similar effects after stroke. Although the benefits of regular exercise are well established there is reported low patient adherence and motivation for implementation among stroke survivors.

Inspiratory muscle strength training (IMST) consists of performing repeated inspirations against resistance with unopposed expirations and uses the diaphragm and accessory muscles to repeatedly inhale against resistance. IMST is performed using either a constant resistance or a pressure-threshold device. Airflow through pressure-threshold devices is regulated by a valve that fully occludes airflow until a prescribed threshold is exceeded, at which point the valve opens to allow airflow. IMST requires the user to develop inspiratory pressures that are significantly greater than those produced during tidal breathing and may be similar to inspiratory pressures produced during high intensity aerobic exercise. Although IMST is not new, novel insights on potential mechanisms for physiological adaptation are promising. IMST has been shown to increase respiratory muscle strength, decrease blood pressure, increase endothelial function, reduce systemic inflammation, reduce heart rate at rest, improve heart rate variability, and during exercise, improve exercise capacity and endurance. IMST has been shown to lead to physiological adaptation in a wide range of populations and has been identified effective in stroke survivors. In a recent systematic review on respiratory muscle training, Pozuelo-Carrascosa et al. identified multiple studies that demonstrated increases in pulmonary function, maximal inspiratory pressure, and walking ability. IMST exercise prescription for frequency and intensity on stroke populations are still being explored and have been used in a wide range of frequencies ranging from 3 times p/week up to 7 times p/week and intensities usually expressed in a percentage of maximal inspiratory pressure (MIP) ranging from 30% of MIP to 75% of MIP, for durations usually expressed in number of breaths or time under tension 5 min (30 breaths) p/session to 60 min (100+ breaths) p/session. IMST has the potential to enhance physical health and resilience in young stroke survivors.

INNOVATION

The feasibility of a remote-home-group delivered Resilience Exercise Training (Res-ET) intervention on young stroke survivors is a novel approach to address the current gaps in post-stroke care. The psychosocial factors of resilience have been identified and assessed, but the relationship between exercise training and resilience in young stroke survivors has not yet been explored. Although IMST has been shown to improve certain physiological outcomes, its effects on psychosocial outcomes, such as resilience and resilience-related factors, are less well known. Furthermore, IMST and resilience have not been studied in the context of young stroke survivor's wellbeing. Remote-home-group delivered exercise training has the potential to effectively increase Res-ET access to a broad demographic covering a wide geographic area. Stroke rehabilitation program Interventions performed in the community may have a favorable effect on the prevention of recurrent stroke and cardiovascular events. Sarfo and colleagues (2018) performed a systematic review on tele-rehabilitation after stroke and found equal or better salutary effects on motor, higher cortical, and mood disorders compared to conventional in-person therapy. A recent feasibility study utilized remote technology (iGetBetter) for at-home self-management on patients with congestive heart failure and had a 95% completion and 80% engagement throughout the study, concluding the remote monitoring program leveraging commonly used mobile and portable consumer devices feasible for their fairly young patient populations with a mean age of 53. High levels of social support have been associated with faster and more extensive recovery after stroke. Group delivered Res-ET intervention may potentially increase social-environmental factors relating to engagement, adherence, and motivation for young stroke survivors. The Res-ET intervention centered in RE-AIM framework may serve as a pragmatic approach in community-based rehabilitation to increase resilience while engaging and supporting young stroke survivors through group delivered IMST exercise training. Therefore, this intervention will fill a crucial gap and potentially highlight a key strategy for enhancing resilience and wellbeing in the community for this highly vulnerable young stroke survivor population.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Res-ET intervention recruitment and retention
timeFrame: 12 months
measure: Feasibility of Res-ET intervention acceptability and adherence
timeFrame: 12 months
Secondary outcomes:
measure: Demographic variables
timeFrame: 12 months
measure: Assess the efficacy potential of Res-ET intervention on resilience measured by UW Resilience Scale.
timeFrame: 12 months
measure: Assess the efficacy potential of Res-ET intervention on Physiological changes in young stroke survivors pre/post Res-ET intervention.
timeFrame: 12 months
measure: Assess the efficacy potential of Res-ET intervention on Psychosocial changes in young stroke survivors pre/post Res-ET intervention.
timeFrame: 12 months
measure: Qualitative assessment of Res-ET
timeFrame: 12 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Department of Occupational & Recreational Therapies
state: Utah
Study officials:
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