StrokeREPSNCT05819333
Augmenting a Post-Stroke Wellness Program With Respiratory Muscle Training
A study testing Exercise Program + Respiratory Strength Training and Exercise Program + Respiratory Relaxation Training in people with Stroke, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Stroke
- What is being tested?
- Exercise Program + Respiratory Strength Training and Exercise Program + Respiratory Relaxation Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2020to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooks Rehabilitation Hospital
Jacksonville, Florida, 32216
About this study
Official title: Augmenting a Post-Stroke Wellness Program With Respiratory Muscle Training: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Exercise Program + Respiratory Strength Training, Exercise Program + Respiratory Relaxation Training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Program + Respiratory Strength TrainingOther
Strength, Flexibility, Cardiovascular exercise + respiratory strength training
Exercise Program + Respiratory Relaxation TrainingOther
Strength, Flexibility, Cardiovascular exercise + respiratory relaxation training
| Study group | Role | What they receive |
|---|---|---|
| Respiratory Strength Training | Experimental | In addition to the Exercise Program of Flexibility, Strengthening and Cardiovascular training, subjects assigned to the Respiratory Strength Training group will use a threshold training device to resist inspiration and expiration (Orygen Dual Valve, Forumed). The respiratory ports are held closed by adjustable-tension springs, and subjects must overcome the tension to inhale or exhale air from the lung. Subjects will complete 5 sets of 5 maximal volume and speed breaths, and rest ~1 minute between sets. Inspiratory muscle training (5 sets of 5 breaths) and expiratory muscle training (5 sets of 5 breaths) will be conducted separately. Initial intensity will be 50-70% of the maximal inspiratory and expiratory pressures the subject can generate. Receives: Other: Exercise Program + Respiratory Strength Training |
| Respiratory Relaxation Training | Active comparator | In addition to the Exercise Program of Flexibility, Strengthening and Cardiovascular training, subjects assigned to the Respiratory Relaxation Training group will be issued the Threshold Positive Expiratory Pressure training device modified to partially inactivate the one-way valve to remove resistance. Much like the Respiratory Strength Training device, the RRT device was selected for its simplicity and adaptability. This device has been used in prior controlled studies as a placebo RST device. Subjects will be instructed to breathe slowly through the device, 5 sets of 5 breaths, with ~1 minute of rest between sets. These "5 sets of 5 breaths" will occur twice during the intervention session, one near the beginning of the session and one near the end. While effects of relaxation breathing exercises may include a modest lowering of systolic BP in some hypertensive patients, this group primarily serves as an active control. Receives: Other: Exercise Program + Respiratory Relaxation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Inspiratory Pressure Change
Maximum inspiratory pressure achieved in five seconds; min value: 0; max value:100; higher value is better.
Measured: Week 9
Secondary outcomes (11)
Maximum Expiratory Pressure Change
Maximum expiratory pressure achieved in five seconds; min value: 0; max value:100; higher value is better.
Measured: Week 9
Peak Cough Flow Change
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.
Measured: Week 9
Forced Vital Capacity (FVC)/Forced Expiratory Volume in one second (FEV1) Change
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.
Measured: Week 9
Six Minute Walk Test Change
Distance walked in Six Minutes; min value: 0; max value:unlimited; higher value is better.
Measured: Week 9
Five Times Sit to Stand Change
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.
Measured: Week 9
Stroke Impact Scale (SIS) - Participation (P) Change
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.
Measured: Week 9
Functional Assessment of Chronic Illness Therapy: Dyspnea Change
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.
Measured: Week 9
Functional Assessment of Chronic Illness Therapy: Fatigue Change
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.
Measured: Week 9
Patient Health Questionnaire-9 (PHQ-9) Change
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.
Measured: Week 9
PROMIS-10 Change
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.
Measured: Week 9
Neuro-QoL Change
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.
Measured: Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start13 Nov 2020
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819333
- Sponsor's protocol ID
- 20K08
- Acronym
- REPS
- Status last verified
- Aug 2025
- First submitted
- 23 Mar 2023
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rose DK, Brunetti G, Cavka K, Hoisington JB, Snyder H, Xue W, Smith BK. Respiratory Strength Training Versus Respiratory Relaxation Training in the Rehabilitation of Physical Impairment, Function, and Return to Participation After Stroke: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Nov 27;13:e59749. doi: 10.2196/59749.
PubMed 39602207
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting a Post-Stroke Wellness Program With Respiratory Muscle Training: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05819333
- Acronym / sponsor ID
- REPS / 20K08
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Respiratory Strength Training | Experimental | Other: Exercise Program + Respiratory Strength TrainingIn addition to the Exercise Program of Flexibility, Strengthening and Cardiovascular training, subjects assigned to the Respiratory Strength Training group will use a threshold training device to resist inspiration and expiration (Orygen Dual Valve, Forumed). The respiratory ports are held closed by adjustable-tension springs, and subjects must overcome the tension to inhale or exhale air from the lung. Subjects will complete 5 sets of 5 maximal volume and speed breaths, and rest ~1 minute between sets. Inspiratory muscle training (5 sets of 5 breaths) and expiratory muscle training (5 sets of 5 breaths) will be conducted separately. Initial intensity will be 50-70% of the maximal inspiratory and expiratory pressures the subject can generate. |
| Respiratory Relaxation Training | Active comparator | Other: Exercise Program + Respiratory Relaxation TrainingIn addition to the Exercise Program of Flexibility, Strengthening and Cardiovascular training, subjects assigned to the Respiratory Relaxation Training group will be issued the Threshold Positive Expiratory Pressure training device modified to partially inactivate the one-way valve to remove resistance. Much like the Respiratory Strength Training device, the RRT device was selected for its simplicity and adaptability. This device has been used in prior controlled studies as a placebo RST device. Subjects will be instructed to breathe slowly through the device, 5 sets of 5 breaths, with ~1 minute of rest between sets. These "5 sets of 5 breaths" will occur twice during the intervention session, one near the beginning of the session and one near the end. While effects of relaxation breathing exercises may include a modest lowering of systolic BP in some hypertensive patients, this group primarily serves as an active control. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise Program + Respiratory Strength TrainingStrength, Flexibility, Cardiovascular exercise + respiratory strength training | Other | Respiratory Strength Training |
| Exercise Program + Respiratory Relaxation TrainingStrength, Flexibility, Cardiovascular exercise + respiratory relaxation training | Other | Respiratory Relaxation Training |
Primary outcome
Maximum Inspiratory Pressure Change
Time frame: Week 9
Maximum inspiratory pressure achieved in five seconds; min value: 0; max value:100; higher value is better.
11 secondary outcomes
Maximum Expiratory Pressure Change
Time frame: Week 9
Peak Cough Flow Change
Time frame: Week 9
Forced Vital Capacity (FVC)/Forced Expiratory Volume in one second (FEV1) Change
Time frame: Week 9
Six Minute Walk Test Change
Time frame: Week 9
Five Times Sit to Stand Change
Time frame: Week 9
Stroke Impact Scale (SIS) - Participation (P) Change
Time frame: Week 9
Functional Assessment of Chronic Illness Therapy: Dyspnea Change
Time frame: Week 9
Functional Assessment of Chronic Illness Therapy: Fatigue Change
Time frame: Week 9
Patient Health Questionnaire-9 (PHQ-9) Change
Time frame: Week 9
PROMIS-10 Change
Time frame: Week 9
Neuro-QoL Change
Time frame: Week 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Derived from this study: PubMed 39602207Rose DK, Brunetti G, Cavka K, Hoisington JB, Snyder H, Xue W, Smith BK. Respiratory Strength Training Versus Respiratory Relaxation Training in the Rehabilitation of Physical Impairment, Function, and Return to Participation After Stroke: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Nov 27;13:e59749. doi: 10.2196/59749.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Program + Respiratory Strength Training and Exercise Program + Respiratory Relaxation Training in people with Stroke, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Inspiratory Pressure Change (time frame: Week 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05819333, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.