Improving post-stroke recovery with respiratory muscle training

Augmenting a Post-Stroke Wellness Program With Respiratory Muscle Training: A Randomized Controlled Trial

This study is testing if adding breathing exercises to a stroke recovery program can help stroke survivors feel better and improve their overall health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 95 Years
• Sex: All
• Sponsor: University of Florida (Academic / other)
• Locations: 1 site (Jacksonville, Florida)
• Trial ID: NCT05819333 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of combining Respiratory Muscle Training with a Stroke Wellness Program for stroke survivors. Participants will engage in a comprehensive exercise program that includes strengthening, cardiovascular, and flexibility training, alongside respiratory exercises over 24 sessions. The study will compare outcomes between those receiving respiratory strengthening and those in a relaxation training group, assessing improvements in respiratory pressure, physical activity, and quality of life. The trial will follow participants for one year to monitor long-term benefits.

Who should consider this trial

Good fit: Ideal candidates are chronic stroke survivors, over 18 years old, who are at least six months post-stroke and can attend the program regularly.

Not a fit: Patients with other neurological conditions, severe arthritis, or serious cardiac issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance recovery and quality of life for stroke survivors.

How similar studies have performed: While the specific combination of respiratory training and stroke wellness programs is novel, similar approaches have shown promise in improving rehabilitation outcomes in stroke patients.

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

Where this trial is running

Jacksonville, Florida

• Brooks Rehabilitation Hospital — Jacksonville, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Dorian K Rose, PhD

Conditions Stroke