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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding respiratory muscle exercises to a stroke recovery program benefits stroke survivors more than the recovery program alone. It includes two types of breathing exercises: one for building strength (Respiratory Strength Training) and another for relaxation (Respiratory Relaxation Training). Researchers aim to determine if the strength training improves lung function, physical activity, and quality of life more than the relaxation exercises. Individuals who had a stroke over six months ago and can walk with some assistance might be suitable for this study. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could enhance stroke recovery programs.

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 prior data suggests that these respiratory training methods are safe for stroke recovery?

Research has shown that respiratory muscle training is generally safe for stroke survivors. Studies have found that this training strengthens muscles and lowers the risk of breathing problems. In one review, four out of five studies reported significant improvements in muscle strength for stroke patients. Additionally, a combined analysis of several studies indicated that this training reduces breathing issues and improves swallowing.

The respiratory relaxation training group serves as a comparison to strength training. While relaxation may slightly lower blood pressure, it primarily functions as a control and has been safely used in past studies.

Overall, treatments in this trial have been well-tolerated in other research, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Exercise + Respiratory Training for Stroke Recovery because it explores innovative ways to enhance stroke rehabilitation. Unlike traditional therapies that might primarily focus on physical exercises and medications, this trial integrates respiratory training, which is relatively novel in stroke recovery. The Respiratory Strength Training is unique because it uses a threshold training device to strengthen breathing muscles by resisting inhalation and exhalation, potentially improving overall respiratory function. Meanwhile, the Respiratory Relaxation Training offers a different approach by using a device that facilitates relaxed breathing, which could help manage stress and blood pressure, serving as a gentle and controlled way to support recovery. By targeting the respiratory system, these methods could offer a complementary benefit to standard stroke rehabilitation protocols.

What evidence suggests that this trial's treatments could be effective for stroke recovery?

This trial will compare two approaches to respiratory training for stroke recovery. Research has shown that exercises to strengthen breathing muscles, performed by participants in the Respiratory Strength Training arm, can improve breathing and lung function in stroke patients. Studies have found that this training can also reduce the risk of breathing problems and assist with swallowing difficulties after a stroke. Better results often occur with higher resistance levels. Meanwhile, participants in the Respiratory Relaxation Training arm will engage in relaxation breathing exercises, which might slightly lower blood pressure in some individuals with hypertension but primarily serve as a comparison in research. Overall, breathing muscle training appears promising in helping stroke survivors regain more breathing strength and function. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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