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 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 expĂ­ratory 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.

Conditions

Interventions

  • Control Other
    Intervention Desc: 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.
    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 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.
    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
Primary Maximal inspiratory pressure Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)
Secondary Maximal expiratory pressure Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)
Secondary Inspiratory endurance Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)
Secondary Dyspnea Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)
Secondary Ocurrence of respiratory complications Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)
Secondary Walking capacity Baseline (week 0), after training (week 8) and one-month follow-up (weeks 12)

Sponsors