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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Quality of Life; Gait; Inspiratory Muscle Training
• Intervention / Treatment: Other: Inspiratory Muscle Training

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Bahia
    • Salvador, Bahia, Brazil
      • Lorena de Oliveira Vaz Miranda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group	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.
Sham Comparator: Control Group	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lorena de Oliveira Vaz Miranda
• Investigators: Study Director: Jamary Oliveira Filho, Federal University of Bahia

Publications and helpful links

General Publications

• Vaz LO, Almeida JC, Froes KSDSO, Dias C, Pinto EB, Oliveira-Filho J. Effects of inspiratory muscle training on walking capacity of individuals after stroke: A double-blind randomized trial. Clin Rehabil. 2021 Sep;35(9):1247-1256. doi: 10.1177/0269215521999591. Epub 2021 Mar 11.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): March 30, 2019
• Study Completion (Actual): March 30, 2019

Study Registration Dates

• First Submitted: May 25, 2017
• First Submitted That Met QC Criteria: May 26, 2017
• First Posted (Actual): May 31, 2017

Study Record Updates

• Last Update Posted (Actual): April 6, 2020
• Last Update Submitted That Met QC Criteria: April 3, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Stroke; Respiratory Aspiration
• Other Study ID Numbers: 65028517.0.0000.0022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data collected in this study will be made available on this basis and will be published in a scientific journal. A master's dissertation will also be built. Further said reports will be provided to the ethics committee while conducting the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No