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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03171272
• Other study ID #: 65028517.0.0000.0022
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: March 30, 2019

Study information

• Verified date: April 2020
• Source: Sarah Network of Rehabilitation Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 30, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gait
• Inspiratory Muscle Training
• Quality of Life
• Respiratory Aspiration
• Stroke

Intervention

Other:
• Inspiratory Muscle Training
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.

Locations

Country	Name	City	State
Brazil	Lorena de Oliveira Vaz Miranda	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Lorena de Oliveira Vaz Miranda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in functional gait perfomarnce	functional gait perfomarnce will be assessed by six minute walk test. (6MWT)	change from Baseline at 6 weeks
Secondary	endurance muscular respiratory	inspiratory and expiratory endurance will be assessed by the threshold devices, following previously described protocols.	Baseline and after 6 weeks
Secondary	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
Secondary	functional gait perfomarnce	functional gait perfomarnce will be assessed by six minute walk test. (6MWT)	three-monsth follow-ups
Secondary	activities of daily living	activities of daily living: will be assessed by measure independence functional (MIF)	Baseline and after 6 weeks
Secondary	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