Ventilatory Muscle Training in Stroke
Combined Inspiratory and Expiratory Muscle Training in Long-term Stroke
1 other identifier
interventional
10
1 country
1
Brief Summary
The purpose of the present study is to determine the utility and effectiveness of combined inspiratory (IMT) and expiratory muscle training (EMT) in improving ventilatory function in people who are disabled by long-term stroke (greater than 8 months following onset) with hemiparesis or hemiplegia. xx subjects will be randomized into 2 parallel groups in which the experimental group will undergo combined IMT and high-resistance EMT and the comparison group will undergo IMT with low- resistance EMT. Both training techniques involve breathing through a tube with known amounts of resistance. Subjects will perform the breathing maneuvers for 10 repetitions, twice daily, 5 days per week for 4 weeks, in the home environment. Adherence will be monitored by reminder telephone calls at least weekly. Outcomes will be assessed using maximum inspiratory and expiratory pressures and standard pulmonary function testing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 stroke
Started Aug 2016
Shorter than P25 for phase_3 stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2016
CompletedFirst Posted
Study publicly available on registry
July 12, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJanuary 17, 2019
January 1, 2019
2.1 years
July 6, 2016
January 15, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum inspiratory pressure
Maximum inspiratory pressure
4 weeks
Secondary Outcomes (2)
Maximum expiratory pressure
4 weeks
Medical Research Council (MRC) dyspnea scale
4 weeks
Study Arms (2)
IMT with Low Resistance EMT
ACTIVE COMPARATORThe 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.
IMT with High Resistance EMT
EXPERIMENTALThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Neurological conditions other than stroke
- Active concurrent exacerbation of cardiopulmonary disease
- Presence of a tracheostomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shirley Ryan AbilityLab
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director of Patient Recovery Unit
Study Record Dates
First Submitted
July 6, 2016
First Posted
July 12, 2016
Study Start
August 1, 2016
Primary Completion
September 1, 2018
Study Completion
December 1, 2018
Last Updated
January 17, 2019
Record last verified: 2019-01