- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02828943
Ventilatory Muscle Training in Stroke
Combined Inspiratory and Expiratory Muscle Training in Long-term Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of the present study is to determine the utility and effectiveness of Expiratory Muscle Training in improving respiratory muscle strength in patients with chronic stroke, when combined with Inspiratory Muscle Training.
20 participants will be recruited from one site (Rehabilitation Institute of Chicago). All participants will give written informed consent before the enrollment in the study. Participants will be compensated for their participation.
Participants will participate in the study for one month. Maximum inspiratory and expiratory pressures will be measured in the seated position. Pulmonary function testing will also be performed in the seated position using a spirometer. Dyspnea will be assessed by the Medical Research Council (MRC) dyspnea scale.
The initial evaluation will consist of recording demographic information and conducting a comprehensive medical history, including: age, gender, race, marital status, education, employment, smoking history, ischemic stroke etiology, stroke severity with NIH Stroke Scale, and stroke location. This information may also be obtained from the RIC electronic medical record. Each subject will undergo a thorough neurologic assessment.
Study participants will be randomly assigned to one of two groups: the experimental group with high resistance EMT and the control group with low resistance EMT. The participants will be randomized to the two groups by an independent staff member at the time of enrollment based on the medical record number. Both groups will undergo IMT because IMT has been found to be effective improving MIP as well as FEV1 and FVC. The patients and those reading the pulmonary function tests will be blinded to the group assignment of each participant.
Upon enrollment in the study, respiratory muscle training will be completed twice daily for 5 days a week for 4 weeks. Training will be provided with the Threshold IMT (Respironics, Murrysville, PA) for inspiratory training and Threshold PEP (Respironics, Murrysville, PA) for expiratory training. The Threshold respiratory trainers are commercially available devices with a spring-loaded valve that provided resistance. The pressure loads can be adjusted at 2 cm H2O intervals for the Threshold IMT, up to 41 cm H2O, and 1 cm H2O intervals for the Threshold PEP, up to 20 cm H2O. EMT training loads in the experimental group will be set to 30% of maximal expiratory pressure while the control group EMT will be set to 5 cm H2O, the lowest setting on the device. IMT training loads will be set to 30% of maximal inspiratory pressure for both groups. The patient will be blinded to the valve titration. Each training session will include one set of 10 repetitions with IMT followed by one set of 10 repetitions with high resistance EMT or low resistance EMT. Patients will be instructed to maintain a respiratory rate of 15-20 breaths/min without rest between repetitions. Participants will be monitored daily by phone and by self-reported log for completion of each training. At two weeks, participants will have a follow-up office visit to monitor progress and those that have completed 80% of their training sessions will increase their training to 40% of maximum inspiratory and expiratory pressures as tolerated.
Each participant will undergo baseline measurement of maximal inspiratory and expiratory pressure and baseline pulmonary function tests as well as after 4 weeks of training. Three trials will be performed with the highest result of the three trials recorded.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Shirley Ryan AbilityLab
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- History of Ischemic stroke
- Stroke impairment 8 months or more
- Hemiparesis in upper and/or lower limb
- Ability to give informed consent
- Ability to follow instructions for study procedures
- Completed a standard multidisciplinary inpatient stroke rehabilitation program consisting of physical, occupational, and speech therapy sessions for at least 3 hours a day for 5 days a week for at least 2 weeks
Exclusion Criteria:
- Neurological conditions other than stroke
- Active concurrent exacerbation of cardiopulmonary disease
- Presence of a tracheostomy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: IMT with Low Resistance EMT
The pressure loads can be adjusted at 2 cm H2O intervals for the Threshold IMT, up to 41 cm H2O, and 1 cm H2O intervals for the Threshold PEP, up to 20 cm H2O.
For the comparator group, EMT will be set to 5 cm H2O, the lowest setting on the device.
IMT training loads will be set to 30% of maximal inspiratory pressure for both groups.
The patient will be blinded to the valve titration.
Each training session will include one set of 10 repetitions with IMT followed by one set of 10 repetitions with low resistance EMT.
Patients will be instructed to maintain a respiratory rate of 15-20 breaths/min without rest between repetitions.
Participants will be monitored daily by phone and by self-reported log for completion of each training.
|
|
EXPERIMENTAL: IMT with High Resistance EMT
The pressure loads can be adjusted at 2 cm H2O intervals for the Threshold IMT, up to 41 cm H2O, and 1 cm H2O intervals for the Threshold PEP, up to 20 cm H2O.
EMT training loads in the experimental group will be set to 30% of maximal expiratory pressure.
IMT training loads will be set to 30% of maximal inspiratory pressure for both groups.
The patient will be blinded to the valve titration.
Each training session will include one set of 10 repetitions with IMT followed by one set of 10 repetitions with high resistance EMT.
Patients will be instructed to maintain a respiratory rate of 15-20 breaths/min without rest between repetitions.
Participants will be monitored daily by phone and by self-reported log for completion of each training.
At two weeks, participants will have a follow-up office visit to monitor progress and those that have completed 80% of their training sessions will increase their training to 40% of maximum inspiratory and expiratory pressures as tolerated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum inspiratory pressure
Time Frame: 4 weeks
|
Maximum inspiratory pressure
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum expiratory pressure
Time Frame: 4 weeks
|
Maximum expiratory pressure
|
4 weeks
|
Medical Research Council (MRC) dyspnea scale
Time Frame: 4 weeks
|
Medical Research Council (MRC) dyspnea scale
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00202271
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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