Home-based Respiratory Training After Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Respiratory training; Other: Control

• Registration Number: NCT02400138
• Lead Sponsor: Federal University of Minas Gerais

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.

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 Timeline

• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-26
• Study Start: 2016-02
• Primary Completion: 2017-06-30
• Study Completion: 2017-07-15
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Respiratory training	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.
Control	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.

Primary Outcome Measures

Name	Time	Method
Maximal inspiratory pressure	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

Name	Time	Method
Dyspnea	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.
Ocurrence of respiratory complications	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.
Maximal expiratory pressure	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.
Inspiratory endurance	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.
Walking capacity	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

Trial Locations

Locations (2)

Department of Physical Therapy, Universidade Federal de Minas Gerais; 🇧🇷 Belo Horizonte, MG, Brazil

NeuroGroup Laboratory; 🇧🇷 Belo Horizonte, MG, Brazil