Brooks Rehabilitation Hospital
Jacksonville, Florida, 32216, United States
NCT Number: NCT05819333
The goal of this clinical trial is to test the hypothesis that combined Respiratory Muscle Training and a Stroke Wellness Program is more effective than a Stroke Wellness Program alone for stroke survivors with and without a smoking exposure history.
Participants will participant in a Stroke Wellness Program consisting of strengthening, cardiovascular and flexibility training program plus respiratory exercise for 24 sessions (3x/week for 8 weeks).
Researchers will compare outcomes to those randomized to a respiratory strengthening program compared to a relaxation training program to see if those who received respiratory strengthening had improved maximal respiratory pressure, improved physical activity and improved quality of life compared to those who received relaxation training.
This study is active but is not currently recruiting participants.
Notify Me18 year–95 year
All sexes
Interventional
Not applicable
Jacksonville, Florida, 32216, United States
Stroke is the leading cause of disability in the United States, and in 25% of cases directly attributable to cigarette smoking. While persistent disability is often attributed to arm or leg weakness, respiratory muscle weakness also impedes post-stroke rehabilitation, reduces quality of life, and increases risk of post-stroke health complications. The investigators' central hypothesis for this pilot study is that a combined Exercise Program (EP) with Respiratory Strength Training (RST) improves physiologic, activity and societal participation outcomes in chronic stroke survivors. Individuals with chronic stroke, with and without smoke exposure will be randomized to an experimental EP + Respiratory Strength Training (RST) group or an active control EP + Respiratory Relaxation training (RRT) group. The EP consists of strengthening, cardiovascular and stretching exercises. The experimental RST consists of resisted inspiration and expiration using an adjustable threshold training device. The active control RRT participants will use a device modified to minimize resistance. Subjects will participate in 24 supervised intervention sessions (3x/week for 8 weeks) and undergo assessments of physiologic system impairment (maximum inspiratory and expiratory pressure, activity (number of steps per day), and societal participation (number of trips outside the home) pre-intervention, at the 4-week midpoint and post-intervention at 9 weeks. The investigators will follow participants for 1-year via monthly phone calls to assess respiratory complication incidence. To investigate the intervention effects for EP/RST vs EP/RRT, the investigators will adopt a mixed effects statistical model to account for the correlation of repeated measurements within each participant. This innovative work will provide the first controlled, empirical evidence concerning the rehabilitative effects of combined EP and RST in those with and without smoking exposure. These data will be instructive to meet a current unmet rehabilitative need, to promote patient-centered care and contribute to decreasing morbidity and mortality for post-stroke Floridians.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Strength, Flexibility, Cardiovascular exercise + respiratory strength training
Strength, Flexibility, Cardiovascular exercise + respiratory relaxation training
Time frame: Week 9
Maximum inspiratory pressure achieved in five seconds; min value: 0; max value:100; higher value is better.
Time frame: Week 9
Maximum expiratory pressure achieved in five seconds; min value: 0; max value:100; higher value is better.
Time frame: Week 9
Peak Cough Flow is the peak airflow during the expiratory phase of a maximal, voluntary cough.; min value: 0; max value:100; higher value is better.
Time frame: Week 9
FEV1/FVC is an index derived from the spirometry test that reflects the severity of obstructive lung disease; min value: 0; max value:100; higher value is better.
Time frame: Week 9
Distance walked in Six Minutes; min value: 0; max value:unlimited; higher value is better.
Time frame: Week 9
Time required to stand up and sit down from a standard height chair with arms across chest; min value: 0; max value:unlimited; lower value is better.
Time frame: Week 9
The SIS-P subsection of the SIS can be used independently and is representative of the participation domain of the World Health Organization - International Classification of Function (WHO-ICF) model; min value: 0; max value:100; higher value is better.
Time frame: Week 9
Subjects will complete the FACIT-D short form, a 10-item questionnaire that measures severity of dyspnea during 10 common functional activities.; min value: 0; max value:100; higher value is better.
Time frame: Week 9
Subjects will complete the FACIT-F short form that assesses their overall all fatigue on a Likert scale during activities of daily living; min value: 0; max value:100; higher value is better.
Time frame: Week 9
The PHQ-9 is a self-report questionnaire in which participants rate how bothered they have been by various problems on a 0-3 scale; min value: 0; max value:100; lower value is better.
Time frame: Week 9
A 10-item global Quality of Life measure, recommended by the International Consortium for Health Outcomes Measurement60 for assessing health status after stroke; min value: 0; max value:100; higher value is better.
Time frame: Week 9
Neuro-QoL is a set of self-report measures that assesses the health-related quality of life (HRQOL) of adults (and children) with neurological disorders; min value: 0; max value:100; higher value is better.
University of Florida
Other
Augmenting a Post-Stroke Wellness Program With Respiratory Muscle Training: A Randomized Controlled Trial
Acronym: REPS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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