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

Primary Purpose

Stroke, Inspiratory Muscle Training, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Inspiratory Muscle Training
Sponsored by
Lorena de Oliveira Vaz Miranda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lorena de Oliveira Vaz Miranda

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

change in functional gait perfomarnce
functional gait perfomarnce will be assessed by six minute walk test. (6MWT)

Secondary Outcome Measures

endurance muscular respiratory
inspiratory and expiratory endurance will be assessed by the threshold devices, following previously described protocols.
maximal respiratory pressures
Maximal respiratory pressures will be assessed by a analogic manovacuometer, following previously described protocols.
functional gait perfomarnce
functional gait perfomarnce will be assessed by six minute walk test. (6MWT)
activities of daily living
activities of daily living: will be assessed by measure independence functional (MIF)
Quality of life
Quality of life will be assessed by the Brazilian version of the EQ5D.

Full Information

First Posted
May 25, 2017
Last Updated
April 3, 2020
Sponsor
Lorena de Oliveira Vaz Miranda
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1. Study Identification

Unique Protocol Identification Number
NCT03171272
Brief Title
Effects of Inspiratory Muscle Training on the Functional Gait Performance of Individuals After Stroke
Official Title
Effects of Inspiratory Muscle Training on the Functional Gait Performance of Individuals After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
March 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lorena de Oliveira Vaz Miranda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Inspiratory Muscle Training, Quality of Life, Gait

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in functional gait perfomarnce
Description
functional gait perfomarnce will be assessed by six minute walk test. (6MWT)
Time Frame
change from Baseline at 6 weeks
Secondary Outcome Measure Information:
Title
endurance muscular respiratory
Description
inspiratory and expiratory endurance will be assessed by the threshold devices, following previously described protocols.
Time Frame
Baseline and after 6 weeks
Title
maximal respiratory pressures
Description
Maximal respiratory pressures will be assessed by a analogic manovacuometer, following previously described protocols.
Time Frame
Baseline, after 6 six weeks and three-monsth follow-ups
Title
functional gait perfomarnce
Description
functional gait perfomarnce will be assessed by six minute walk test. (6MWT)
Time Frame
three-monsth follow-ups
Title
activities of daily living
Description
activities of daily living: will be assessed by measure independence functional (MIF)
Time Frame
Baseline and after 6 weeks
Title
Quality of life
Description
Quality of life will be assessed by the Brazilian version of the EQ5D.
Time Frame
Baseline, after 6 weeks and three-monsth follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamary Oliveira Filho
Organizational Affiliation
Federal University of Bahia
Official's Role
Study Director
Facility Information:
Facility Name
Lorena de Oliveira Vaz Miranda
City
Salvador
State/Province
Bahia
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33706569
Citation
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.
Results Reference
derived

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

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