Home-based Respiratory Training After Stroke

Completed

Phase N/A Results N/A

Trial Description

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 and endurance of the inspiratory and expiratory muscles, fatigue, exercise capacity, and quality of life with stroke subjects. 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 Threshold device regulated at 40% of the subjects' maximal inspiratory and expíratory pressure values, five times/week over eight weeks during 30 minutes/day. The control group will undertake the same protocol, but the participants will receive the threshold devices without the resistance valves. At baseline, post intervention, and four and 12 weeks after the cessation of the interventions, researchers blinded to group allocations will collect the following outcome measures: maximal inspiratory and expiratory pressures, endurance, fatigue, dyspnea sensation, exercise capacity, and quality of life.

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 and endurance of the inspiratory and expiratory muscles, fatigue, exercise capacity, and quality of life (QoL) with stroke subjects.
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 Threshold® IMT and the Threshold™ PEP regulated at 40% of the subjects' maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) values, five times/week over eight weeks during 30 minutes/day. The control group will undertake the same protocol, but the participants will receive the threshold devices without the resistance valves. At baseline, post intervention, and four and 12 weeks after the cessation (two follow-ups) of the interventions, researchers blinded to group allocations will collect all outcome measures.
Study outcomes: Primary outcomes will be MIP and MEP. Secondary outcomes will include inspiratory and expiratory endurance, fatigue, dyspnea sensation, exercise capacity, and QoL.

Conditions

Interventions

  • Control Device
    Intervention Desc: The control/sham group will underwent exactly the same protocol and bi-weekly monitoring at home, but the participants will receive the threshold devices with the minimum resistance of the spring.
    ARM 1: Kind: Experimental
    Label: Respiratory training
    Description: Respiratory training will include training of the inspiratory and expiratory muscles five times per week over eight weeks, divided into three five-minute sessions of inspiratory training and the same doses of expiratory training, totaling 30 minutes of training. The training program will follow previously employed protocols for stroke survivors and will be carried-out with the Thresholds regulated at 40% of the subjects' maximal inspiratory and expiratory pressure values.
    ARM 2: Kind: Experimental
    Label: Control
    Description: The control/sham group will underwent exactly the same protocol and bi-weekly monitoring at home, but the participants will receive the threshold devices with the minimum resistance of the spring, which will be also concealed. The control group will also attend the bi-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.
  • Respiratory training Other
    Intervention Desc: Respiratory training will include training of the inspiratory and expiratory muscle five times per week over eight weeks, divided into three five-minute sessions of inspiratory training and the same doses of expiratory training, totaling 30 minutes of training. The training program will follow previously employed protocols for stroke survivors and will be carried-out with the threshold regulated at 40% of the subjects' maximal inspiratory and expiratory pressure values.
    ARM 1: Kind: Experimental
    Label: Respiratory training
    Description: Respiratory training will include training of the inspiratory and expiratory muscles five times per week over eight weeks, divided into three five-minute sessions of inspiratory training and the same doses of expiratory training, totaling 30 minutes of training. The training program will follow previously employed protocols for stroke survivors and will be carried-out with the Thresholds regulated at 40% of the subjects' maximal inspiratory and expiratory pressure values.
    ARM 2: Kind: Experimental
    Label: Control
    Description: The control/sham group will underwent exactly the same protocol and bi-weekly monitoring at home, but the participants will receive the threshold devices with the minimum resistance of the spring, which will be also concealed. The control group will also attend the bi-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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Maximal inspiratory and expiratory pressures up to three-monsth follow-ups No
Secondary Inspiratory and expiratory endurance Baseline, after intervention, and one and three-monsth follow-ups No
Secondary Dyspnea sensation Baseline, after intervention, and one and three-monsth follow-ups No
Secondary Exercise capacity Baseline, after intervention, and one and three-monsth follow-ups No
Secondary Quality of life Baseline, after intervention, and one and three-monsth follow-ups No

Sponsors