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Exercise + Respiratory Training for Stroke Recovery (REPS Trial)
N/A
Recruiting
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to ambulate 20 feet with no more than contact guard assist, with or without an assistive device or orthotic device
Diagnosis of stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 9
Awards & highlights
REPS Trial Summary
This trial tests if stroke survivors benefit from respiratory exercise with a Stroke Wellness Program, compared to just the Program alone, to help improve physical activity, maximal respiratory pressure and quality of life.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include muscle soreness from exercise and fatigue due to increased physical activity. There might also be discomfort associated with respiratory muscle training.
REPS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can walk 20 feet with minimal help or using a support device.
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I have been diagnosed with a stroke.
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I am older than 18 years.
REPS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 9
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 9
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Inspiratory Pressure Change
Secondary outcome measures
Five Times Sit to Stand Change
Forced Vital Capacity (FVC)/Forced Expiratory Volume in one second (FEV1) Change
Functional Assessment of Chronic Illness Therapy: Dyspnea Change
+8 moreREPS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Respiratory Strength TrainingExperimental Treatment1 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 TrainingActive Control1 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.
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,341 Previous Clinical Trials
715,587 Total Patients Enrolled
19 Trials studying Stroke
2,283 Patients Enrolled for Stroke
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Eligibility Criteria:
This trial includes the following eligibility 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.I can walk 20 feet with minimal help or using a support device.I have a bone or joint problem that affects how I move.I can use exercise equipment by myself or with help.I have been diagnosed with a stroke.You are currently involved in other exercise or physical therapy programs.I do not have serious heart conditions or recent major heart issues.My blood pressure is very high and cannot be controlled below 180/100 mmHg.You need to use extra oxygen before starting the study.I am older than 18 years.I do not have severe breathing problems (my lung function is above 50%).I experience severe pain when I put weight on my legs.I can attend a wellness program three times a week for eight weeks.I can run a quarter mile without stopping.You live in a community, not in a care facility.It has been over 6 months since my stroke.
Research Study Groups:
This trial has the following groups:- Group 1: Respiratory Strength Training
- Group 2: Respiratory Relaxation Training
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can individuals younger than 50 years old participate in this experiment?
"Individuals aged between 18 and 95 years old can take part in this clinical trial."
Answered by AI
What are the criteria to participate in this clinical experiment?
"The clinical trial is accepting participants aged 18 to 95 who had a stroke. A total of 80 patients are required for the study."
Answered by AI
How many participants have been accepted for this research project?
"Correct. Clinicaltrials.gov provides data that this clinical trial is currently seeking participants; it was originally posted on November 13th 2020 and last updated on April 5th 2023. The study has a requirement of 80 subjects from one site."
Answered by AI
Are recruitment activities ongoing for this research project?
"Affirmative. According to clinicaltrials.gov, the research study that was initially posted on November 13th 2020 is actively searching for volunteers. The protocol includes 80 participants from a single location and has been updated most recently on April 5th 2023."
Answered by AI
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