Effects of Inspiratory Muscle Training on the Functional Gait Performance of Individuals After Stroke

Study Overview
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Brief Summary
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The most commonly observed sequel after stroke is muscle weakness, which can also be identified in respiratory muscles, in the acute and chronic phases, and may compromise the lung function of these individuals. Studies have shown that lower Pimax values are found in non-community ambulators, and gait velocity has been reported as an important indicator of functionality after stroke, with higher gait velocity values associated with greater community participation and better quality of life. This study will test the hypothesis that training of the inspiratory muscles is effective in improving strength and endurance of the inspiratory muscles and functionality, including speed of gait, functional gait perfomarnce, activities of daily living 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 muscles with the Power Breath Medical Classic device regulated at 50% of the subjects' maximal inspiratory pressure values, five times/week over six weeks, twice a day for 15 minutes, totaling 30 minutes/day. The control group will undertake the same protocol, but the participants will receive the devices with a minimal load, wich corresponds to 1cmH2O. Both groups will participate in the rehabilitation program for 6 weeks. At baseline and post intervention, after the cessation of the interventions, researchers blinded to group allocations will collect the following outcome measures: maximal respiratory pressures, respiratory muscle endurance, functional gait performance, activities of daily living and quality of life. After 12 weeks will collect again maximal inspiratory pressures and functional gait performance.

Detailed Description
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The most commonly observed sequel after stroke is muscle weakness, which can also be identified in respiratory muscles, in the acute and chronic phases, and may compromise the lung function of these individuals. Studies have shown that lower Pimax values are found in non-community ambulators, and gait velocity has been reported as an important indicator of functionality after stroke, with higher gait velocity values associated with greater community participation and better Quality of life. Aim: This study will test the hypothesis that training of the inspiratory muscles is effective in improving strength and endurance of the inspiratory muscles and functional gait perfomarnce, activities of daily living and quality of life with stroke subjects. Design: For this prospective, triple-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 muscles with the PowerBreath Medic Plus regulated at 50% of the subjects' maximal inspiratory pressure (MIP) values, five times/week over six weeks during 30 minutes/day. The control group will undertake the same protocol, but the participants will receive the threshold devices with minimal resistance valves. At baseline and post intervention after the cessation of the interventions, researchers blinded to group allocations will collect all outcome measures. After 12 weeks will collect again maximal inspiratory pressures and functional gait performance. Study outcomes: Primary outcomes will be functional gait perfomarnce. Secondary outcomes will include inspiratory endurance, activities of daily living and quality of life.

Official Title
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Effects of Inspiratory Muscle Training on the Functional Gait Performance of Individuals After Stroke

Conditions
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Stroke, Inspiratory Muscle Training, Quality of Life, Gait

Intervention / Treatment
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* Other: Inspiratory Muscle Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with hemiparesis after stroke, of any etiology, ischemic or hemorrhagic, that carry out walking with or without assistance locomotion; Aged between 18 and 80 years of age; In the chronic period (between 6 months and 5 years); clinically stable (Measured through clinical and hemodynamic stability: vital signs within normal and released for physical activity by the physician), who present with inspiratory muscle weakness, defined as Pimáx less than -80cmH2O and score in the normal Mini Mental State Examination (MMSE) For schooling. Exclusion Criteria: Smokers and ex-smokers for more than five years, presence of facial paralysis that prevents lip occlusion, associated neurological diseases, orthopedic alterations that include distortions of the chest cavity or pains that prevent the tests from being performed, respiratory dysfunctions, cardiac dysfunctions that Compromise hemodynamic stability.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br> | Other: Inspiratory Muscle Training<br>* Experimental: IMT will include training of the inspiratory muscles five times per week over six weeks, divided into two fiftten-minute sessions of inspiratory training totaling 30 minutes of training. Thresholds regulated at 50% of the subjects' maximal inspiratory pressure values, the load being increased weekly. Associated with the IMT, subjects will participate in the rehabilitation program, when they will perform 7 sessions of physiotherapy per week, totaling 42 sessions, as well as 180 minutes per week of aerobic exercise, for six weeks. Sham Group: This group will underwent exactly the same protocol 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 participate in the rehabilitation program and undergo the same procedures, except for the load adjustments.<br>|
| Sham Comparator: Control Group<br> | Other: Inspiratory Muscle Training<br>* Experimental: IMT will include training of the inspiratory muscles five times per week over six weeks, divided into two fiftten-minute sessions of inspiratory training totaling 30 minutes of training. Thresholds regulated at 50% of the subjects' maximal inspiratory pressure values, the load being increased weekly. Associated with the IMT, subjects will participate in the rehabilitation program, when they will perform 7 sessions of physiotherapy per week, totaling 42 sessions, as well as 180 minutes per week of aerobic exercise, for six weeks. Sham Group: This group will underwent exactly the same protocol 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 participate in the rehabilitation program and undergo the same procedures, except for the load adjustments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in functional gait perfomarnce | functional gait perfomarnce will be assessed by six minute walk test. (6MWT) | change from Baseline at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endurance muscular respiratory | inspiratory and expiratory endurance will be assessed by the threshold devices, following previously described protocols. | Baseline and after 6 weeks | 
| maximal respiratory pressures | Maximal respiratory pressures will be assessed by a analogic manovacuometer, following previously described protocols. | Baseline, after 6 six weeks and three-monsth follow-ups | 
| functional gait perfomarnce | functional gait perfomarnce will be assessed by six minute walk test. (6MWT) | three-monsth follow-ups | 
| activities of daily living | activities of daily living: will be assessed by measure independence functional (MIF) | Baseline and after 6 weeks | 
| Quality of life | Quality of life will be assessed by the Brazilian version of the EQ5D. | Baseline, after 6 weeks and three-monsth follow-ups |