Clinical trial NCT05819333: Augmenting a Post-Stroke Wellness Program With Respiratory Muscle Training
Official title: Augmenting a Post-Stroke Wellness Program With Respiratory Muscle Training: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of stroke
* Greater than 6 months post-stroke
* Signed letter of medical approval from primary care physician to participate in this research study
* Community dwelling
* Ability to attend the wellness program 3x/week for eight weeks
* Ability to follow instructions or mimic exercises
* Ability to communicate adverse effects such as pain or fatigue or the need for assistance
* Able to ambulate 20 feet with no more than contact guard assist, with or without an assistive device or orthotic device
* Able to access exercise equipment independently or with caregiver assist
* Greater than 18 years of age

Exclusion Criteria:

* Neurologic condition other than stroke, i.e. Parkinson's Disease, multiple sclerosis
* Severe, functional limiting arthritis
* Orthopedic condition that limits mobility
* Severe weight-bearing pain
* Current participation in other physical rehabilitation services or exercise programs
* Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within the past year, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living). Anyone meeting New York Heart Association criteria for Class 3 or Class 4 heart disease will be excluded
* Severe hypertension: with systolic \> 200 mmHg and diastolic \> 110 mmHg at rest, that cannot be medically controlled into the resting range of 180/100 mmHg
* Use of supplemental oxygen at baseline
* Severe obstructive pulmonary disease (Classification of Global Initiative for Chronic Obstructive Lung Disease (GOLD)39 3 or higher, indicating FEV1\<50% predicted)
* Treatment for pneumonia or lower respiratory infection within the past month
* Able to run one-quarter mile without stopping

Primary outcomes:
measure: Maximum Inspiratory Pressure Change
timeFrame: Week 9
Secondary outcomes:
measure: Maximum Expiratory Pressure Change
timeFrame: Week 9
measure: Peak Cough Flow Change
timeFrame: Week 9
measure: Forced Vital Capacity (FVC)/Forced Expiratory Volume in one second (FEV1) Change
timeFrame: Week 9
measure: Six Minute Walk Test Change
timeFrame: Week 9
measure: Five Times Sit to Stand Change
timeFrame: Week 9
measure: Stroke Impact Scale (SIS) - Participation (P) Change
timeFrame: Week 9
measure: Functional Assessment of Chronic Illness Therapy: Dyspnea Change
timeFrame: Week 9
measure: Functional Assessment of Chronic Illness Therapy: Fatigue Change
timeFrame: Week 9
measure: Patient Health Questionnaire-9 (PHQ-9) Change
timeFrame: Week 9
measure: PROMIS-10 Change
timeFrame: Week 9
measure: Neuro-QoL Change
timeFrame: Week 9
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Brooks Rehabilitation Hospital
state: Florida
Study officials:
References: