search
Back to results

Ventilatory Muscle Training in Stroke

Primary Purpose

Stroke, Pulmonary Ventilation, Exercise Therapy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
IMT with High Resistance EMT
IMT with Low Resistance EMT
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. History of Ischemic stroke
  2. Stroke impairment 8 months or more
  3. Hemiparesis in upper and/or lower limb
  4. Ability to give informed consent
  5. Ability to follow instructions for study procedures
  6. 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:

  1. Neurological conditions other than stroke
  2. Active concurrent exacerbation of cardiopulmonary disease
  3. Presence of a tracheostomy

Sites / Locations

  • Shirley Ryan AbilityLab

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

IMT with Low Resistance EMT

IMT with High Resistance EMT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Maximum inspiratory pressure
Maximum inspiratory pressure

Secondary Outcome Measures

Maximum expiratory pressure
Maximum expiratory pressure
Medical Research Council (MRC) dyspnea scale
Medical Research Council (MRC) dyspnea scale

Full Information

First Posted
July 6, 2016
Last Updated
January 15, 2019
Sponsor
Shirley Ryan AbilityLab
search

1. Study Identification

Unique Protocol Identification Number
NCT02828943
Brief Title
Ventilatory Muscle Training in Stroke
Official Title
Combined Inspiratory and Expiratory Muscle Training in Long-term Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Pulmonary Ventilation, Exercise Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMT with Low Resistance EMT
Arm Type
Active Comparator
Arm Description
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.
Arm Title
IMT with High Resistance EMT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
IMT with High Resistance EMT
Intervention Type
Behavioral
Intervention Name(s)
IMT with Low Resistance EMT
Primary Outcome Measure Information:
Title
Maximum inspiratory pressure
Description
Maximum inspiratory pressure
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Maximum expiratory pressure
Description
Maximum expiratory pressure
Time Frame
4 weeks
Title
Medical Research Council (MRC) dyspnea scale
Description
Medical Research Council (MRC) dyspnea scale
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Ventilatory Muscle Training in Stroke

We'll reach out to this number within 24 hrs