80 Participants Needed

Exercise + Respiratory Training for Stroke Recovery

(REPS Trial)

DK
BS
Overseen ByBarbara Smith, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.23467

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.12348

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.
See 7 more

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.
See 8 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Respiratory Strength TrainingExperimental Treatment1 Intervention
Group II: Respiratory Relaxation TrainingActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

Published Research Related to This Trial

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.
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.
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.
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]

Citations

Comprehensive Respiratory Muscle Training Improves Pulmonary Function and Respiratory Muscle Strength in Acute Stroke Patients. [2021]
Effectiveness of Respiratory Muscle Training for Pulmonary Function and Walking Ability in Patients with Stroke: A Systematic Review with Meta-Analysis. [2020]
Respiratory Muscle Training Improves Strength and Decreases the Risk of Respiratory Complications in Stroke Survivors: A Systematic Review and Meta-analysis. [2021]
Respiratory muscle training improves exercise tolerance and respiratory muscle function/structure post-stroke at short term: A systematic review and meta-analysis. [2022]
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]
Effect of respiratory muscle training in asthma: A systematic review and meta-analysis. [2023]
High-Intensity Respiratory Muscle Training Improves Strength and Dyspnea Poststroke: A Double-Blind Randomized Trial. [2019]
Respiratory muscle training increases respiratory muscle strength and reduces respiratory complications after stroke: a systematic review. [2018]
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