ResilienceNCT05348044
Enhancing Resilience in Young Stroke Survivors With Res-ET
A study testing Res-ET intervention in people with Resilience and Stroke, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Resilience, Stroke
- What is being tested?
- Res-ET intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2022to 10 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Occupational & Recreational Therapies
Salt Lake City, Utah, 84108
About this study
Official title: Feasibility Study to Increase Resilience Through an At-home Virtual Exercise Training (Res-ET) Intervention Using Inspiratory Muscle Strength Training (IMST)
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.
Read more
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
Read the 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.
- Conditions
- Resilience, Stroke
- Being tested
- Res-ET intervention
- Keywords
- IMST, Young Stroke Survivor, Resilience, At-home program
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Res-ET interventionOther
Remote IMST delivery on Resilience
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Res-ET intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 12 months
Secondary outcomes (5)
Demographic variables
Summary Statistics
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start5 May 2022
- Primary completion5 Jan 2023
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for ResilienceStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The proposed feasibility study is a rolling enrollment mixed-methods, one-group quasi-experimental design.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nate Thomas (Larry Nathan), University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05348044
- Sponsor's protocol ID
- IRB_00150247
- Status last verified
- Apr 2023
- First submitted
- 17 Mar 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently no plan to share IPD.
Publications
Amtmann D, Bamer AM, Alschuler KN, Bocell FD, Ehde DM, Jensen MP, Johnson K, Nery-Hurwit MB, Salem R, Silverman A, Smith AE, Terrill AL, Molton I. Development of a resilience item bank and short forms. Rehabil Psychol. 2020 May;65(2):145-157. doi: 10.1037/rep0000312. Epub 2020 Feb 10.
PubMed 32039618Angevaren M, Aufdemkampe G, Verhaar HJ, Aleman A, Vanhees L. Physical activity and enhanced fitness to improve cognitive function in older people without known cognitive impairment. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD005381. doi: 10.1002/14651858.CD005381.pub3.
PubMed 18646126Billinger SA, Boyne P, Coughenour E, Dunning K, Mattlage A. Does aerobic exercise and the FITT principle fit into stroke recovery? Curr Neurol Neurosci Rep. 2015;15(2):519. doi: 10.1007/s11910-014-0519-8.
PubMed 25475494Chekroud SR, Gueorguieva R, Zheutlin AB, Paulus M, Krumholz HM, Krystal JH, Chekroud AM. Association between physical exercise and mental health in 1.2 million individuals in the USA between 2011 and 2015: a cross-sectional study. Lancet Psychiatry. 2018 Sep;5(9):739-746. doi: 10.1016/S2215-0366(18)30227-X. Epub 2018 Aug 8.
PubMed 30099000Childs E, de Wit H. Regular exercise is associated with emotional resilience to acute stress in healthy adults. Front Physiol. 2014 May 1;5:161. doi: 10.3389/fphys.2014.00161. eCollection 2014.
PubMed 24822048Cipriano GF, Cipriano G Jr, Santos FV, Guntzel Chiappa AM, Pires L, Cahalin LP, Chiappa GR. Current insights of inspiratory muscle training on the cardiovascular system: a systematic review with meta-analysis. Integr Blood Press Control. 2019 May 20;12:1-11. doi: 10.2147/IBPC.S159386. eCollection 2019.
PubMed 31190975Craighead DH, Heinbockel TC, Hamilton MN, Bailey EF, MacDonald MJ, Gibala MJ, Seals DR. Time-efficient physical training for enhancing cardiovascular function in midlife and older adults: promise and current research gaps. J Appl Physiol (1985). 2019 Nov 1;127(5):1427-1440. doi: 10.1152/japplphysiol.00381.2019. Epub 2019 Sep 26.
PubMed 31556835Craighead DH, Heinbockel TC, Freeberg KA, Rossman MJ, Jackman RA, Jankowski LR, Hamilton MN, Ziemba BP, Reisz JA, D'Alessandro A, Brewster LM, DeSouza CA, You Z, Chonchol M, Bailey EF, Seals DR. Time-Efficient Inspiratory Muscle Strength Training Lowers Blood Pressure and Improves Endothelial Function, NO Bioavailability, and Oxidative Stress in Midlife/Older Adults With Above-Normal Blood Pressure. J Am Heart Assoc. 2021 Jul 6;10(13):e020980. doi: 10.1161/JAHA.121.020980. Epub 2021 Jun 29.
PubMed 34184544Deuster PA, Silverman MN. Physical fitness: a pathway to health and resilience. US Army Med Dep J. 2013 Oct-Dec:24-35.
PubMed 24146240Edwards JD, Kapral MK, Lindsay MP, Fang J, Swartz RH. Young Stroke Survivors With No Early Recurrence at High Long-Term Risk of Adverse Outcomes. J Am Heart Assoc. 2019 Jan 8;8(1):e010370. doi: 10.1161/JAHA.118.010370.
PubMed 30563428Gunnes M, Indredavik B, Langhammer B, Lydersen S, Ihle-Hansen H, Dahl AE, Askim T; LAST Collaboration group. Associations Between Adherence to the Physical Activity and Exercise Program Applied in the LAST Study and Functional Recovery After Stroke. Arch Phys Med Rehabil. 2019 Dec;100(12):2251-2259. doi: 10.1016/j.apmr.2019.04.023. Epub 2019 Jul 30.
PubMed 31374191Hackett ML, Pickles K. Part I: frequency of depression after stroke: an updated systematic review and meta-analysis of observational studies. Int J Stroke. 2014 Dec;9(8):1017-25. doi: 10.1111/ijs.12357. Epub 2014 Aug 12.
PubMed 25117911Holland JN, Schmidt AT. Static and Dynamic Factors Promoting Resilience following Traumatic Brain Injury: A Brief Review. Neural Plast. 2015;2015:902802. doi: 10.1155/2015/902802. Epub 2015 Aug 4.
PubMed 26347352Ivey FM, Hafer-Macko CE, Macko RF. Exercise rehabilitation after stroke. NeuroRx. 2006 Oct;3(4):439-50. doi: 10.1016/j.nurx.2006.07.011.
PubMed 17012057Johnson L, Bird ML, Muthalib M, Teo WP. An Innovative STRoke Interactive Virtual thErapy (STRIVE) Online Platform for Community-Dwelling Stroke Survivors: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 Jul;101(7):1131-1137. doi: 10.1016/j.apmr.2020.03.011. Epub 2020 Apr 10.
PubMed 32283048
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Increase Resilience Through an At-home Virtual Exercise Training (Res-ET) Intervention Using Inspiratory Muscle Strength Training (IMST)
- ClinicalTrials.gov ID
- NCT05348044
- Acronym / sponsor ID
- IRB_00150247
- Conditions
- Resilience, Stroke
- Keywords
- IMST, Young Stroke Survivor, Resilience, At-home program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The proposed feasibility study is a rolling enrollment mixed-methods, one-group quasi-experimental design.
| Arm | Type | Receives |
|---|---|---|
| Res-ET intervention | Experimental | Other: Res-ET interventionRes-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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Res-ET interventionRemote IMST delivery on Resilience | Other | Res-ET intervention |
Primary outcome
Feasibility of Res-ET intervention recruitment and retention
Time frame: 12 months
Feasibility will be assessed by Recruitment and Adherence measures, recruit-ability (20 participants in 6 months) and retention (retain 80% of enrolled participants)
Feasibility of Res-ET intervention acceptability and adherence
Time frame: 12 months
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.
5 secondary outcomes
Demographic variables
Time frame: 12 months
Assess the efficacy potential of Res-ET intervention on resilience measured by UW Resilience Scale.
Time frame: 12 months
Assess the efficacy potential of Res-ET intervention on Physiological changes in young stroke survivors pre/post Res-ET intervention.
Time frame: 12 months
Assess the efficacy potential of Res-ET intervention on Psychosocial changes in young stroke survivors pre/post Res-ET intervention.
Time frame: 12 months
Qualitative assessment of Res-ET
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Results publication: PubMed 32039618Amtmann D, Bamer AM, Alschuler KN, Bocell FD, Ehde DM, Jensen MP, Johnson K, Nery-Hurwit MB, Salem R, Silverman A, Smith AE, Terrill AL, Molton I. Development of a resilience item bank and short forms. Rehabil Psychol. 2020 May;65(2):145-157. doi: 10.1037/rep0000312. Epub 2020 Feb 10.
- Results publication: PubMed 18646126Angevaren M, Aufdemkampe G, Verhaar HJ, Aleman A, Vanhees L. Physical activity and enhanced fitness to improve cognitive function in older people without known cognitive impairment. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD005381. doi: 10.1002/14651858.CD005381.pub3.
- Results publication: PubMed 25475494Billinger SA, Boyne P, Coughenour E, Dunning K, Mattlage A. Does aerobic exercise and the FITT principle fit into stroke recovery? Curr Neurol Neurosci Rep. 2015;15(2):519. doi: 10.1007/s11910-014-0519-8.
- Results publication: PubMed 30099000Chekroud SR, Gueorguieva R, Zheutlin AB, Paulus M, Krumholz HM, Krystal JH, Chekroud AM. Association between physical exercise and mental health in 1.2 million individuals in the USA between 2011 and 2015: a cross-sectional study. Lancet Psychiatry. 2018 Sep;5(9):739-746. doi: 10.1016/S2215-0366(18)30227-X. Epub 2018 Aug 8.
- Results publication: PubMed 24822048Childs E, de Wit H. Regular exercise is associated with emotional resilience to acute stress in healthy adults. Front Physiol. 2014 May 1;5:161. doi: 10.3389/fphys.2014.00161. eCollection 2014.
- Results publication: PubMed 31190975Cipriano GF, Cipriano G Jr, Santos FV, Guntzel Chiappa AM, Pires L, Cahalin LP, Chiappa GR. Current insights of inspiratory muscle training on the cardiovascular system: a systematic review with meta-analysis. Integr Blood Press Control. 2019 May 20;12:1-11. doi: 10.2147/IBPC.S159386. eCollection 2019.
- Results publication: PubMed 31556835Craighead DH, Heinbockel TC, Hamilton MN, Bailey EF, MacDonald MJ, Gibala MJ, Seals DR. Time-efficient physical training for enhancing cardiovascular function in midlife and older adults: promise and current research gaps. J Appl Physiol (1985). 2019 Nov 1;127(5):1427-1440. doi: 10.1152/japplphysiol.00381.2019. Epub 2019 Sep 26.
- Results publication: PubMed 34184544Craighead DH, Heinbockel TC, Freeberg KA, Rossman MJ, Jackman RA, Jankowski LR, Hamilton MN, Ziemba BP, Reisz JA, D'Alessandro A, Brewster LM, DeSouza CA, You Z, Chonchol M, Bailey EF, Seals DR. Time-Efficient Inspiratory Muscle Strength Training Lowers Blood Pressure and Improves Endothelial Function, NO Bioavailability, and Oxidative Stress in Midlife/Older Adults With Above-Normal Blood Pressure. J Am Heart Assoc. 2021 Jul 6;10(13):e020980. doi: 10.1161/JAHA.121.020980. Epub 2021 Jun 29.
- Results publication: PubMed 24146240Deuster PA, Silverman MN. Physical fitness: a pathway to health and resilience. US Army Med Dep J. 2013 Oct-Dec:24-35.
- Results publication: PubMed 30563428Edwards JD, Kapral MK, Lindsay MP, Fang J, Swartz RH. Young Stroke Survivors With No Early Recurrence at High Long-Term Risk of Adverse Outcomes. J Am Heart Assoc. 2019 Jan 8;8(1):e010370. doi: 10.1161/JAHA.118.010370.
- Results publication: PubMed 31374191Gunnes M, Indredavik B, Langhammer B, Lydersen S, Ihle-Hansen H, Dahl AE, Askim T; LAST Collaboration group. Associations Between Adherence to the Physical Activity and Exercise Program Applied in the LAST Study and Functional Recovery After Stroke. Arch Phys Med Rehabil. 2019 Dec;100(12):2251-2259. doi: 10.1016/j.apmr.2019.04.023. Epub 2019 Jul 30.
- Results publication: PubMed 25117911Hackett ML, Pickles K. Part I: frequency of depression after stroke: an updated systematic review and meta-analysis of observational studies. Int J Stroke. 2014 Dec;9(8):1017-25. doi: 10.1111/ijs.12357. Epub 2014 Aug 12.
- Individual participant dataSharing planned: No. Currently no plan to share IPD.
Related trials for Resilience
Not yet recruiting
Effects of Art-Based Group Reminiscence Therapy on Resilience and Joy of Living in Older Adults
Resilience, Psychological, Joy of Living
Not yet recruiting
The Effect of Happiness Workshops on Nursing Students' Levels of Psychological Resilience
Psychological Resilience, Nursing Students
Active, not recruiting
Future School of Comprehensive Well-Being
Learning, Comprehensive Wellbeing
Recruiting
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Caregiver Distress, Emotional Distress
Active, not recruiting
Emergency Preparedness for Caregivers of Persons With Dementia: Disaster PrepWise
Caregiver Resilience and Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Res-ET intervention in people with Resilience and Stroke, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Res-ET intervention recruitment and retention (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05348044, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.