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Home-based Respiratory Training After Stroke

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ClinicalTrials.gov Identifier: NCT02400138
Recruitment Status : Completed
First Posted : March 26, 2015
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Luci Fuscaldi Teixeira-Salmela, Federal University of Minas Gerais

Study Description
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Brief Summary:
Weakness of the respiratory muscles demonstrated by individuals with stroke, may generate important symptoms, such as fatigue and dyspnea. Since adequate strength of the inspiratory and expiratory muscles is required, mainly when performing physical activities, rehabilitation interventions for stroke subjects should include respiratory training. This study will test the hypothesis that home-based combined training of the inspiratory and expiratory muscles is effective in improving strength of the inspiratory and expiratory muscles, endurance of the inspiratory muscles, dyspnea, walking capacity, and ocurrence of respiratory complications after stroke. For this clinical trial, people after stroke will be randomly allocated into either experimental or control/sham groups. The experimental group will undertake training of the inspiratory plus expiratory muscles with the Orygen Dual Valve device, regulated at 50% of the subjects' maximal inspiratory and expíratory pressure values, seven times/week over eight weeks during 40 minutes/day. The control group will undertake the same protocol, but the participants will receive the devices without resistance. At baseline, post intervention, and four weeks after the cessation of the intervention, researchers blinded to group allocations will collect the following outcome measures: maximal inspiratory and expiratory pressures, inspiratory endurance, dyspnea, walking capacity, and ocurrence of respiratory complications.

Condition or disease Intervention/treatment Phase
Stroke Other: Respiratory training Other: Control Not Applicable

Detailed Description:

Rationale: Weakness of the respiratory muscles demonstrated by individuals with stroke, may generate important symptoms, such as fatigue and dyspnea. Since adequate strength of the inspiratory and expiratory muscles is required, mainly when performing physical activities, rehabilitation interventions for stroke subjects should include respiratory training.

Aim: This study will test the hypothesis that home-based combined inspiratory muscular training (IMT) plus expiratory muscular training (EMT) program is effective in improving strength of the inspiratory and expiratory muscles, endurance of the inspiratory muscles, dyspnea, walking capacity, and ocurrence of respiratory complications after stroke.

Design: For this prospective, double-blinded, randomized clinical trial, people after stroke will be randomly allocated into either experimental or control/sham groups. The experimental group will undertake training of the inspiratory plus expiratory muscles with the Orygen Dual Valve, regulated at 50% of the subjects' maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) values, seven times/week over eight weeks during 40 minutes/day. The control group will undertake the same protocol, but the participants will receive the devices without resistance. At baseline, post intervention, and four weeks after the cessation of the intervention, researchers blinded to group allocations will collect all outcome measures.

Study outcomes: Primary outcomes will be MIP. Secondary outcomes will include MEP, inspiratory endurance, dyspnea, walking capacity, and ocurrence of respiratory complications.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Home-based Respiratory Training After Stroke: A Randomized Controlled Trial
Actual Study Start Date : February 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : July 15, 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: Respiratory training
Respiratory training will include training of the inspiratory and expiratory muscles seven times per week over eight weeks, during 40 minutes per day, divided into two 20-min sessions (morning and afternoon). Each 20-min session comprised 4-min sets of respiratory training, followed by 1-min rest between the sets. The training program will be carried-out with the Orygen Dual Valve device, regulated at 50% of the subjects' maximal inspiratory and expiratory pressure values. Once a week, the treating physiotherapist performed a home visit, measured the current values of inspiratory and expiratory strength, and progressed the load to 50% of the new values.
 Other: Respiratory training
Respiratory training will include training of the inspiratory and expiratory muscle seven times per week over eight weeks, during 40 minutes, divided into two 20-min sessions (morning and afternoon). Each 20-min session comprised 4-min sets of respiratory training, followed by 1-min rest between the sets. The training program will be carried-out with the Orygen Dual Valve regulated at 50% of the subjects' maximal inspiratory and expiratory pressure values. Once a week, the treating physiotherapist performed a home visit, measured the current values of inspiratory and expiratory strength, and progressed the load to 50% of the new values.
Sham Comparator: Control
The control/sham group will underwent exactly the same protocol and weekly monitoring at home, but the participants will receive the devices without resistance of the spring, which will be also concealed. The control group will also attend the weekly sessions and undergo the same procedures, except for the load adjustments. If the training proves to be effective, the control subjects will be informed and have the choice to receive the training with proper loads.
 Other: Control
The control/sham group will underwent exactly the same protocol and weekly monitoring at home, but the participants will receive the devices without resistance of the spring.


Outcome Measures
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Primary Outcome Measures :
  1. Maximal inspiratory pressure [ Time Frame: Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12) ]
    Changes in maximal inspiratory pressures will be assessed by a digital manovacuometer, following previously described protocols.


Secondary Outcome Measures :
  1. Maximal expiratory pressure [ Time Frame: Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12) ]
    Changes in maximal expiratory pressures will be assessed by a digital manovacuometer, following previously described protocols.

  2. Inspiratory endurance [ Time Frame: Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12) ]
    Changes in inspiratory endurance will be assessed by the powerbreathe device, following previously described protocols.

  3. Dyspnea [ Time Frame: Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12) ]
    Changes in dyspnea will be assessed by the Medical Research Council Scale.

  4. Ocurrence of respiratory complications [ Time Frame: Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12) ]
    Changes in ocurrence of respiratory complications will be assessed by asking the participants, whether and how often they were admitted to a hospital, due to respiratory reasons.

  5. Walking capacity [ Time Frame: Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12) ]
    Changes in walking capacity will be evaluated by the six-minute walking test


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Stroke survivors will be eligible if they: were >3 months and <5 years after their last episode of stroke; were >20 years of age; their maximal inspiratory pressure was <80 cmH2O or maximal expiratory pressure was <90 cmH2O [18]; were not undertaking any respiratory training; and were able to provide informed consent.

Exclusion Criteria:

Subjects will be excluded if they had cognitive deficits, facial palsy, associated respiratory diseases, or unstable conditions which might prevent measurement or training; or undergone thoracic or abdominal surgery.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02400138


Locations
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Brazil
Department of Physical Therapy, Universidade Federal de Minas Gerais
Belo Horizonte, MG, Brazil, 31270-901
NeuroGroup Laboratory
Belo Horizonte, MG, Brazil, 31270-901
Sponsors and Collaborators
Federal University of Minas Gerais
Investigators
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Study Director: Fatima Rodrigues-de-Paula, Ph.D. Federal University of Minas Gerais
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Luci Fuscaldi Teixeira-Salmela, Titular professor, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT02400138    
Other Study ID Numbers: RTS-01
First Posted: March 26, 2015    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases