Respiratory Strength Training Versus Respiratory Relaxation Training in the Rehabilitation of Physical Impairment, Function, and Return to Participation After Stroke: Protocol for a Randomized Controlled Trial

BackgroundPersistent disability in chronic stroke survivors is often attributed to arm or leg weakness; however, respiratory muscle weakness also impedes poststroke rehabilitation, reduces quality of life, and increases the risk of health complications. Respiratory complicati...

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Main Authors: Dorian K Rose, Gina Brunetti, Kathryn Cavka, J Brooke Hoisington, Hannah Snyder, Wei Xue, Barbara K Smith
Format: Article
Language:English
Published: JMIR Publications 2024-11-01
Series:JMIR Research Protocols
Online Access:https://www.researchprotocols.org/2024/1/e59749
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author Dorian K Rose
Gina Brunetti
Kathryn Cavka
J Brooke Hoisington
Hannah Snyder
Wei Xue
Barbara K Smith
author_facet Dorian K Rose
Gina Brunetti
Kathryn Cavka
J Brooke Hoisington
Hannah Snyder
Wei Xue
Barbara K Smith
author_sort Dorian K Rose
collection DOAJ
description BackgroundPersistent disability in chronic stroke survivors is often attributed to arm or leg weakness; however, respiratory muscle weakness also impedes poststroke rehabilitation, reduces quality of life, and increases the risk of health complications. Respiratory complications are common after stroke and place patients at risk for both prolonged functional disability and mortality. In addition, stroke survivors face ongoing cardiovascular disease that places them at risk for recurrent stroke. ObjectiveThe study aims to compare the effects of 2 respiratory training programs, paired with individualized flexibility, strengthening, and cardiovascular exercise programs, on physiologic, activity, and societal participation outcomes in chronic stroke survivors. MethodsThis study will be a randomized controlled trial. Participants are 80 community-dwelling adults with chronic stroke. In conjunction with a 24-session (3 times/week for 8 weeks), American Heart Association–informed, whole-body exercise program, participants will be randomized to receive either respiratory strength training or respiratory relaxation training. Study intervention will be directed by a physical therapist and take place in a community fitness center. Outcome assessments will occur in a clinical research center. The primary outcome measure is maximal respiratory pressure. Secondary outcome measures include airway clearance, walking endurance, spatial-temporal gait characteristics, community walking, functional strength and fatigue, depression, and societal participation measures. Longer-term societal participation is a complex domain that may be influenced by other factors beyond physical function. Participants’ health status will be monitored for 1 year following the intervention for falls, respiratory illness, and hospitalizations. Additional subanalyses will evaluate the effect of smoke exposure on short- and long-term outcomes. Outcome assessors are blinded to group assignments. Respiratory relaxation training is an active comparator, but no pure control group is included. ResultsThis study was funded in March 2020 with enrollment commencing in November 2020. Completion of enrollment is projected for May 2025 with a study projected end date of April 2026. Published results are anticipated in Fall 2026. ConclusionsResults from this study will improve our understanding of the additive benefits of respiratory exercises on short- and long-term physiologic, functional, and societal gains for these individuals. These data will be instructive to meet a current unmet rehabilitative need to promote patient-centered care and contribute to decreasing morbidity and mortality in chronic stroke survivors. Trial RegistrationClinicalTrials.gov: NCT05819333; https://clinicaltrials.gov/study/NCT05819333 International Registered Report Identifier (IRRID)DERR1-10.2196/59749
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spelling doaj-art-0ea72e9cdc98482ab5f4de4bd44ed8112024-11-27T14:00:34ZengJMIR PublicationsJMIR Research Protocols1929-07482024-11-0113e5974910.2196/59749Respiratory Strength Training Versus Respiratory Relaxation Training in the Rehabilitation of Physical Impairment, Function, and Return to Participation After Stroke: Protocol for a Randomized Controlled TrialDorian K Rosehttps://orcid.org/0000-0002-9751-0298Gina Brunettihttps://orcid.org/0000-0002-1062-3207Kathryn Cavkahttps://orcid.org/0009-0001-7671-6449J Brooke Hoisingtonhttps://orcid.org/0009-0001-1453-0745Hannah Snyderhttps://orcid.org/0009-0006-3426-9181Wei Xuehttps://orcid.org/0000-0003-2680-8510Barbara K Smithhttps://orcid.org/0000-0002-3255-7036 BackgroundPersistent disability in chronic stroke survivors is often attributed to arm or leg weakness; however, respiratory muscle weakness also impedes poststroke rehabilitation, reduces quality of life, and increases the risk of health complications. Respiratory complications are common after stroke and place patients at risk for both prolonged functional disability and mortality. In addition, stroke survivors face ongoing cardiovascular disease that places them at risk for recurrent stroke. ObjectiveThe study aims to compare the effects of 2 respiratory training programs, paired with individualized flexibility, strengthening, and cardiovascular exercise programs, on physiologic, activity, and societal participation outcomes in chronic stroke survivors. MethodsThis study will be a randomized controlled trial. Participants are 80 community-dwelling adults with chronic stroke. In conjunction with a 24-session (3 times/week for 8 weeks), American Heart Association–informed, whole-body exercise program, participants will be randomized to receive either respiratory strength training or respiratory relaxation training. Study intervention will be directed by a physical therapist and take place in a community fitness center. Outcome assessments will occur in a clinical research center. The primary outcome measure is maximal respiratory pressure. Secondary outcome measures include airway clearance, walking endurance, spatial-temporal gait characteristics, community walking, functional strength and fatigue, depression, and societal participation measures. Longer-term societal participation is a complex domain that may be influenced by other factors beyond physical function. Participants’ health status will be monitored for 1 year following the intervention for falls, respiratory illness, and hospitalizations. Additional subanalyses will evaluate the effect of smoke exposure on short- and long-term outcomes. Outcome assessors are blinded to group assignments. Respiratory relaxation training is an active comparator, but no pure control group is included. ResultsThis study was funded in March 2020 with enrollment commencing in November 2020. Completion of enrollment is projected for May 2025 with a study projected end date of April 2026. Published results are anticipated in Fall 2026. ConclusionsResults from this study will improve our understanding of the additive benefits of respiratory exercises on short- and long-term physiologic, functional, and societal gains for these individuals. These data will be instructive to meet a current unmet rehabilitative need to promote patient-centered care and contribute to decreasing morbidity and mortality in chronic stroke survivors. Trial RegistrationClinicalTrials.gov: NCT05819333; https://clinicaltrials.gov/study/NCT05819333 International Registered Report Identifier (IRRID)DERR1-10.2196/59749https://www.researchprotocols.org/2024/1/e59749
spellingShingle Dorian K Rose
Gina Brunetti
Kathryn Cavka
J Brooke Hoisington
Hannah Snyder
Wei Xue
Barbara K Smith
Respiratory Strength Training Versus Respiratory Relaxation Training in the Rehabilitation of Physical Impairment, Function, and Return to Participation After Stroke: Protocol for a Randomized Controlled Trial
JMIR Research Protocols
title Respiratory Strength Training Versus Respiratory Relaxation Training in the Rehabilitation of Physical Impairment, Function, and Return to Participation After Stroke: Protocol for a Randomized Controlled Trial
title_full Respiratory Strength Training Versus Respiratory Relaxation Training in the Rehabilitation of Physical Impairment, Function, and Return to Participation After Stroke: Protocol for a Randomized Controlled Trial
title_fullStr Respiratory Strength Training Versus Respiratory Relaxation Training in the Rehabilitation of Physical Impairment, Function, and Return to Participation After Stroke: Protocol for a Randomized Controlled Trial
title_full_unstemmed Respiratory Strength Training Versus Respiratory Relaxation Training in the Rehabilitation of Physical Impairment, Function, and Return to Participation After Stroke: Protocol for a Randomized Controlled Trial
title_short Respiratory Strength Training Versus Respiratory Relaxation Training in the Rehabilitation of Physical Impairment, Function, and Return to Participation After Stroke: Protocol for a Randomized Controlled Trial
title_sort respiratory strength training versus respiratory relaxation training in the rehabilitation of physical impairment function and return to participation after stroke protocol for a randomized controlled trial
url https://www.researchprotocols.org/2024/1/e59749
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