Home-based Respiratory Training After Stroke

October 24, 2017 updated by: Luci Fuscaldi Teixeira-Salmela, Federal University of Minas Gerais

Effects of Home-based Respiratory Training After Stroke: A Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • MG
      • Belo Horizonte, MG, Brazil, 31270-901
        • Department of Physical Therapy, Universidade Federal de Minas Gerais
      • Belo Horizonte, MG, Brazil, 31270-901
        • NeuroGroup Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)
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.
Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)
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.
Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)
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.
Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)
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
Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Minas Gerais

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Fatima Rodrigues-de-Paula, Ph.D., Federal University of Minas Gerais

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RTS-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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