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Inspiratory Muscle Training and Respiratory Electromyographic Activity in COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Inspiratory Muscle Training
Pulmonary Rehabilitation
Sponsored by
University of Santa Cruz do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease,

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Will be included in the study subjects of both sexes aged between 40 and 80 years. For the control group will participate in healthy subjects, non-smokers with normal lung function. For Group TMI + Rehabilitation, Non-Rehabilitated and Rehabilitation Group participate COPD patients with GOLD staging II and III, participants and non-participants of a PR program respectively, where individuals not participating (GTMINR) will be those who will enter the PR program during the stipulated time of study and the participants have (GTMIR) should be included in the project for at least eight weeks, the time required for a program to provide RP's effects in COPD

Exclusion Criteria:

  • Not participate in the study and Group TMI + Rehabilitation, Non-Rehabilitated and Rehabilitation Group, individuals who do not fit the criteria for GOLD in stages II and III, which are in acute disease, presenting hemodynamic instability, aneurysm, cognitive impairment or any other co-morbidity that prevents this study. For the GC will not participate smokers, ex-smokers or who have compromised lung function, individuals participating in regular physical activity, ie three or more times per week, and no pathology that affects the cardiorespiratory system. Also excluded are those who do not sign the consent form.

Sites / Locations

  • Universidade de Santa Cruz do Sul

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group Pulmonary Rehabilitation

Group TMI + Pulmonary Rehabilitation

Control Group

COPD group not rehabilitation

Arm Description

Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard desinsuflativo (expiration at the time of muscle contraction), is performed three times a week for eight weeks.

Will be held inspiratory muscle training associated with a pulmonary rehabilitation program. The inspiratory muscle training is performed with a load of 40 to 50% of the muscle strength of the subjects. Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard deflation (expiration at the time of muscle contraction), is performed three times a week for eight weeks.

Inspiratory muscle training will be held three times a week for eight weeks

Outcomes

Primary Outcome Measures

Muscle electromyographic activity of the accessory Inspiration

Secondary Outcome Measures

Inspiratory Muscle Training
Assessment of lung volumes
assessment of respiratory muscle strength
breathing pattern assessment

Full Information

First Posted
November 3, 2013
Last Updated
April 24, 2017
Sponsor
University of Santa Cruz do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT02014155
Brief Title
Inspiratory Muscle Training and Respiratory Electromyographic Activity in COPD
Official Title
Effects of Inspiratory Muscle Training on Respiratory Electromyographic Activity in Patients With COPD Participants and Non-participants of a Pulmonary Rehabilitation Program
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (Actual)
Primary Completion Date
November 1, 2014 (Actual)
Study Completion Date
January 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Santa Cruz do Sul

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Intended to treat disorders of the respiratory muscles can use the device Threshold IMT ® through an inspiratory muscle training (IMT) that allows training of the inspiratory muscles, the chief of these being the diaphragm which is which objectified the improvement of its function . To monitor the action of the respiratory muscles can be used several tools such as manometer that aims to assess respiratory pressures, ie, the strength of respiratory muscles, or the Surface Electromyography (sEMG) that allow evaluating the electromyographic activity of muscles analyzed. From a quantitative clinical trial, randomized and blinded, composed of 45 individuals obtained by random convenience and divided into three groups, COPD participating in a pulmonary rehabilitation program (RP) which will make TMI (TGR - Trained Group Rehabilitated), COPD does not participant in a PR program (TGNR - Trained Group not Rehabilitated) and a control group composed of healthy individuals (CG) that seek to analyze the electromyographic activity of sternocleidomastoid (SCM) and diaphragm muscle strength, lung volumes and breathing patterns before and after a period of eight weeks of TMI. Manual will also be held dynamometry to compare the grip strength of the CG, TGR and TGNR only at baseline. Hypothesis: The Inspiratory Muscle Training (IMT) increases the maximal inspiratory pressure (MIP) in COPD patients regardless of whether they are enrolled in a program of pulmonary rehabilitation (PR). TMI alters the breathing pattern in COPD patients regardless of whether they were entered into a PR program. Patients with COPD who do not participate in a PR program have higher handgrip strength compared to patients who did not participate in a PR program. There is decreased activity of the sternocleidomastoid muscle due to increased activity in the diaphragmatic muscle fibers after a period of TMI. TMI in COPD patients participating in a program RP produces greater increase in MIP, the handgrip strength, improves breathing pattern and a greater reduction in the activity of the SCM muscle and diaphragm than in those who did not participate in a program RP. There will be a reduction in respiratory rate, heart rate, systolic and diastolic blood pressure and increased oxygen saturation at the end of the TMI. TMI reduce the degree of dyspnea reported by patients as MRC scale at the end of the training period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive Pulmonary Disease,

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Pulmonary Rehabilitation
Arm Type
Experimental
Arm Description
Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard desinsuflativo (expiration at the time of muscle contraction), is performed three times a week for eight weeks.
Arm Title
Group TMI + Pulmonary Rehabilitation
Arm Type
Experimental
Arm Description
Will be held inspiratory muscle training associated with a pulmonary rehabilitation program. The inspiratory muscle training is performed with a load of 40 to 50% of the muscle strength of the subjects. Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard deflation (expiration at the time of muscle contraction), is performed three times a week for eight weeks.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
Inspiratory muscle training will be held three times a week for eight weeks
Arm Title
COPD group not rehabilitation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training
Intervention Description
Will be held inspiratory muscle training associated with a pulmonary rehabilitation program. The inspiratory muscle training is performed with a load of 40 to 50% of the muscle strength of the subjects.
Intervention Type
Other
Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard deflation (expiration at the time of muscle contraction), is performed three times a week for eight weeks.
Primary Outcome Measure Information:
Title
Muscle electromyographic activity of the accessory Inspiration
Time Frame
The electromyographic activity will be evaluated during the inspiratory cycles for one minute, It will be evaluated over eight weeks
Secondary Outcome Measure Information:
Title
Inspiratory Muscle Training
Time Frame
Will be performed with frequency of three days non-consecutive week, for eight weeks
Title
Assessment of lung volumes
Time Frame
will be performed previously to the study and at the end, over eight weeks
Title
assessment of respiratory muscle strength
Time Frame
will be performed previously to the study and at the end, as well as weekly to adjust the pressure load, It will be evaluated over eight weeks
Title
breathing pattern assessment
Time Frame
will be performed previously to the study and at the end of the same, It will be evaluated over eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Will be included in the study subjects of both sexes aged between 40 and 80 years. For the control group will participate in healthy subjects, non-smokers with normal lung function. For Group TMI + Rehabilitation, Non-Rehabilitated and Rehabilitation Group participate COPD patients with GOLD staging II and III, participants and non-participants of a PR program respectively, where individuals not participating (GTMINR) will be those who will enter the PR program during the stipulated time of study and the participants have (GTMIR) should be included in the project for at least eight weeks, the time required for a program to provide RP's effects in COPD Exclusion Criteria: Not participate in the study and Group TMI + Rehabilitation, Non-Rehabilitated and Rehabilitation Group, individuals who do not fit the criteria for GOLD in stages II and III, which are in acute disease, presenting hemodynamic instability, aneurysm, cognitive impairment or any other co-morbidity that prevents this study. For the GC will not participate smokers, ex-smokers or who have compromised lung function, individuals participating in regular physical activity, ie three or more times per week, and no pathology that affects the cardiorespiratory system. Also excluded are those who do not sign the consent form.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dulciane N Paiva, Doctor
Organizational Affiliation
University of Santa Cruz do Sul
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Diogo F Bordin, Academic
Organizational Affiliation
University of Santa Cruz do Sul
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dannuey M Cardoso, Master
Organizational Affiliation
University of Santa Cruz do Sul
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Andrea LG da Silva, Doctor
Organizational Affiliation
University of Santa Cruz do Sul
Official's Role
Study Director
Facility Information:
Facility Name
Universidade de Santa Cruz do Sul
City
Santa Cruz do Sul
State/Province
Rio Grande do Sul
Country
Brazil

12. IPD Sharing Statement

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Inspiratory Muscle Training and Respiratory Electromyographic Activity in COPD

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