Exercise + Respiratory Training for Stroke Recovery

(REPS Trial)

Overseen By Barbara Smith, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Neurologic conditions, Cardiac conditions, Severe hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 24

Duration: 8 weeks

80 Participants Needed

Trial Summary

What is the purpose of this 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Respiratory Relaxation Training and Respiratory Muscle Training for stroke recovery?

Research shows that respiratory muscle training (RMT) can improve lung function and walking ability in stroke patients, helping them breathe better and move more easily. This treatment strengthens the muscles used for breathing, which can be weakened after a stroke. ^{1 2 3 4 5}

Is respiratory muscle training safe for humans?

Research on respiratory muscle training (RMT) for stroke recovery and other conditions like asthma suggests it is generally safe for humans. These studies focus on improving breathing and muscle strength, and while they don't specifically address safety, they do not report any significant safety concerns. ^{1 2 4 5 6}

How does the Exercise + Respiratory Training treatment differ from other stroke recovery treatments?

This treatment is unique because it combines exercise with respiratory muscle training, which has been shown to improve both respiratory function and walking ability in stroke patients. Unlike other treatments that may focus solely on physical rehabilitation, this approach targets the respiratory muscles to enhance overall recovery. ^{1 2 4 7 8}

Eligibility Criteria

This trial is for stroke survivors over 18 years old who are at least 6 months post-stroke, can follow instructions or mimic exercises, and have medical approval to participate. They must be able to attend a wellness program three times a week for eight weeks and move around with minimal assistance. People with severe lung disease, heart conditions, uncontrolled high blood pressure, recent pneumonia treatment or those in other exercise programs cannot join.

Inclusion Criteria

I can walk 20 feet with minimal help or using a support device.

I can use exercise equipment by myself or with help.

I have been diagnosed with a stroke.

Exclusion Criteria

I have a neurological condition, but it's not a stroke.

I have severe arthritis that limits my daily activities.

I have been treated for pneumonia or a lung infection in the last month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a Stroke Wellness Program with Respiratory Muscle Training for 24 sessions over 8 weeks

8 weeks

24 visits (in-person)

Midpoint Assessment

Assessment of physiologic system impairment, activity, and societal participation at the 4-week midpoint

1 week

Post-Treatment Assessment

Assessment of outcomes including maximal respiratory pressure, physical activity, and quality of life at the end of the 9-week intervention

1 week

Follow-up

Participants are monitored for respiratory complications via monthly phone calls for 1 year

12 months

Treatment Details

Interventions

• Respiratory Relaxation Training
• Respiratory Strength Training

Trial Overview The study tests if adding Respiratory Muscle Training to a Stroke Wellness Program improves respiratory strength, physical activity levels, and quality of life more than just the Wellness Program with relaxation training. Participants will engage in either strengthening exercises or relaxation techniques alongside regular stroke recovery workouts.

Participant Groups

Group I: Respiratory Strength Training Experimental Treatment 1 Intervention

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.

Group II: Respiratory Relaxation Training Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Findings from Research

In a study involving 122 stroke patients, those who underwent respiratory muscle training (RMT) showed significantly greater improvements in pulmonary function and respiratory muscle strength compared to those receiving standard rehabilitation after just four weeks.

The RMT group also experienced a lower incidence of respiratory complications, such as pneumonia, indicating that RMT may be an effective intervention to enhance recovery and reduce risks in acute stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive Respiratory Muscle Training Improves Pulmonary Function and Respiratory Muscle Strength in Acute Stroke Patients. Choi, HE., Jo, GY., Do, HK., et al.[2021]

Respiratory muscle training (RMT) significantly improves key respiratory function parameters, such as forced expiratory volume (FEV1) and walking ability in post-stroke patients, based on a systematic review of 19 randomized controlled trials.

While RMT enhances respiratory function and walking capacity, it does not show improvements in daily living activities or balance, indicating that its benefits are primarily focused on respiratory health and mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Respiratory Muscle Training for Pulmonary Function and Walking Ability in Patients with Stroke: A Systematic Review with Meta-Analysis. Pozuelo-Carrascosa, DP., Carmona-Torres, JM., Laredo-Aguilera, JA., et al.[2020]

Respiratory muscle training significantly improved muscle strength and lung function in stroke patients, with notable increases in maximal inspiratory and expiratory pressures, as well as forced expiratory volume and vital capacity, based on a meta-analysis of 9 randomized controlled trials.

The benefits of respiratory muscle training were sustained for up to 12 weeks, leading to improved walking capacity and a reduced risk of respiratory complications, highlighting its efficacy as a rehabilitation intervention for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory Muscle Training Improves Strength and Decreases the Risk of Respiratory Complications in Stroke Survivors: A Systematic Review and Meta-analysis. Wu, F., Liu, Y., Ye, G., et al.[2021]

A systematic review and meta-analysis of 9 high-quality studies involving 463 stroke patients found that respiratory muscle training (RMT) significantly improves exercise tolerance and diaphragm thickness in the short term, with a moderate effect size (SMD = 0.65).

Combined inspiratory and expiratory muscle training was more effective than just inspiratory training alone, but none of the benefits were maintained in the medium term, indicating that ongoing training may be necessary for lasting effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory muscle training improves exercise tolerance and respiratory muscle function/structure post-stroke at short term: A systematic review and meta-analysis. Fabero-Garrido, R., Del Corral, T., Angulo-Díaz-Parreño, S., et al.[2022]

In a study involving 37 stroke patients, combining respiratory muscle training (RMT) with the abdominal drawing-in maneuver (ADIM) significantly improved pulmonary function, as shown by greater increases in forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) compared to other groups.

The integrated training group (ITG) also exhibited significantly enhanced respiratory muscle activity, particularly in the diaphragm and external intercostal muscles, indicating that this combination training is effective for improving respiratory function in post-stroke hemiplegia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the combination of respiratory muscle training and abdominal drawing-in maneuver on respiratory muscle activity in patients with post-stroke hemiplegia: a pilot randomized controlled trial. Kim, CY., Lee, JS., Kim, HD., et al.[2016]

Inspiratory muscle training (IMT) significantly improved maximal inspiratory pressure (PImax) in adults with asthma, indicating enhanced respiratory muscle function, with a mean difference of 21.95 cmH2O based on a meta-analysis of 11 studies involving 270 participants.

While IMT did not show significant changes in lung function or exercise capacity overall, it was found that training loads greater than 50% of PImax and durations longer than 6 weeks were beneficial for improving exercise capacity, suggesting a dose-response relationship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of respiratory muscle training in asthma: A systematic review and meta-analysis. Lista-Paz, A., Bouza Cousillas, L., Jácome, C., et al.[2023]

In a randomized trial with 38 stroke patients, high-intensity home-based respiratory muscle training significantly improved both inspiratory and expiratory muscle strength, as well as inspiratory endurance, while also reducing feelings of breathlessness (dyspnea).

The training was conducted for 40 minutes daily over 8 weeks, and the benefits in muscle strength and reduced dyspnea were maintained even one month after the training ended, although there was no significant improvement in walking capacity or respiratory complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Intensity Respiratory Muscle Training Improves Strength and Dyspnea Poststroke: A Double-Blind Randomized Trial. Parreiras de Menezes, KK., Nascimento, LR., Ada, L., et al.[2019]

Respiratory muscle training significantly increases both maximal inspiratory and expiratory pressures in adults with respiratory muscle weakness following a stroke, with improvements of 7 cmH2O and 13 cmH2O respectively, based on a systematic review of five trials involving 263 participants.

This training also reduces the risk of respiratory complications after stroke, with a relative risk of 0.38 compared to no or sham interventions, although it remains uncertain if these improvements translate to better activity and participation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory muscle training increases respiratory muscle strength and reduces respiratory complications after stroke: a systematic review. Menezes, KK., Nascimento, LR., Ada, L., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comprehensive Respiratory Muscle Training Improves Pulmonary Function and Respiratory Muscle Strength in Acute Stroke Patients. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Respiratory Muscle Training for Pulmonary Function and Walking Ability in Patients with Stroke: A Systematic Review with Meta-Analysis. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Respiratory Muscle Training Improves Strength and Decreases the Risk of Respiratory Complications in Stroke Survivors: A Systematic Review and Meta-analysis. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Respiratory muscle training improves exercise tolerance and respiratory muscle function/structure post-stroke at short term: A systematic review and meta-analysis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effects of the combination of respiratory muscle training and abdominal drawing-in maneuver on respiratory muscle activity in patients with post-stroke hemiplegia: a pilot randomized controlled trial. [2016]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of respiratory muscle training in asthma: A systematic review and meta-analysis. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

High-Intensity Respiratory Muscle Training Improves Strength and Dyspnea Poststroke: A Double-Blind Randomized Trial. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Respiratory muscle training increases respiratory muscle strength and reduces respiratory complications after stroke: a systematic review. [2018]