Respiratory Strength Training versus Respiratory Relaxation Training in the Rehabilitation of Physical Impairment, Function and Return to Participation Post-Stroke: Protocol for a Randomized Controlled Trial (Preprint)

Abstract

Persistent disability in chronic stroke survivors is often attributed to arm or leg weakness; however, respiratory muscle weakness also impedes post-stroke rehabilitation, reduces quality of life, and increases risk of health complications. Respiratory complications are common after stroke and place patients at risk for both prolonged functional disability and mortality. Additionally, stroke survivors face ongoing cardiovascular disease that places them at risk for recurrent stroke.

The study objective is to compare the effects of two respiratory training programs, paired with an individualized flexibility, strengthening and cardiovascular exercise program, on physiologic, activity, and societal participation outcomes in chronic stroke survivors.

This study will be a randomized controlled trial. Participants are 80 community-dwelling adults with chronic stroke. In conjunction with a 24-session (3x/week for 8 weeks) American Heart Association (AHA)-informed whole-body exercise program, participants will be randomized to receive either respiratory strength training (RST) or respiratory relaxation training (RRT). 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 measures are maximal respiratory pressures. 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 sub-analyses will evaluate the effect of smoke exposure on short- and long-term outcomes. Outcome assessors are blinded to group assignment. RRT is an active comparator, but no pure control group is included.

This study was funded March 2020 with enrollment commencing November 2020. Completion of enrollment is projected May 2025 with study projected end date of April 2026. Published results are anticipated Fall 2026. Results 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.

ClinicalTrials.gov: NCT05819333