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

NCT03171272 | Completed DMC

• 1 other identifier: 65028517.0.0000.0022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Inspiratory Muscle Training; Quality of Life; Gait

Outcome Measures

Primary Outcomes (1)

• change in functional gait perfomarnce

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

  change from Baseline at 6 weeks

Secondary Outcomes (5)

• endurance muscular respiratory

  Baseline and after 6 weeks

• maximal respiratory pressures

  Baseline, after 6 six weeks and three-monsth follow-ups

• functional gait perfomarnce

  three-monsth follow-ups

• activities of daily living

  Baseline and after 6 weeks

• Quality of life

  Baseline, after 6 weeks and three-monsth follow-ups

Study Arms (2)

Experimental Group

EXPERIMENTAL

Other: Inspiratory Muscle Training

Control Group

SHAM COMPARATOR

Other: Inspiratory Muscle Training

Interventions

Inspiratory Muscle Training OTHER

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.

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lorena de Oliveira Vaz Miranda: lead

Study Sites (1)

Lorena de Oliveira Vaz Miranda

Salvador, Estado de Bahia, Brazil

Location

Related Publications (1)

• 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.

  PMID: 33706569 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jamary Oliveira Filho

  Federal University of Bahia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Graduated in Physiotherapy by UFMG (2009) and specialist in Respiratory Physiotherapy by ASSOBRAFIR (2016)

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: May 31, 2017
• Study Start: June 1, 2017
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2019
• Last Updated: April 6, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)