NCT05819333Completed
Augmenting a Post-Stroke Wellness Program With Respiratory Muscle Training
Augmenting a Post-Stroke Wellness Program With Respiratory Muscle Training: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 85 (actual)
- First submitted
- 23 Mar 2023
- Start date
- 13 Nov 2020
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- University of Florida
- Diseases
- Stroke
- NCT number
- NCT05819333
What you commit to
- Study type: Interventional
- Participants enrolled: 85
- From 13 Nov 2020 to the primary completion date, 30 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Neurologic condition other than stroke, i.e. Parkinson's Disease, multiple sclerosis
- Orthopedic condition that limits mobility
- 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
- 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
Other
- Severe, functional limiting arthritis
- Severe weight-bearing pain
- Current participation in other physical rehabilitation services or exercise programs
- Use of supplemental oxygen at baseline
- Able to run one-quarter mile without stopping
Who the study is looking for
- 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
Age in the registry: 18 years to 95 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brooks Rehabilitation Hospital Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.