Inspiratory Muscle Training and Respiratory Electromyographic Activity in COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Effects of Inspiratory Muscle Training on Respiratory Electromyographic Activity in Patients With COPD Participants and Non-participants of a Pulmonary Rehabilitation Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02014155
• Other study ID #: UNISC_001
• Status: Completed
• Phase: N/A
• First received: November 3, 2013
• Last updated: April 24, 2017
• Start date: August 2013
• Est. completion date: January 1, 2015

Study information

• Verified date: April 2017
• Source: University of Santa Cruz do Sul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

1. 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).

2. TMI alters the breathing pattern in COPD patients regardless of whether they were entered into a PR program.

3. 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.

4. There is decreased activity of the sternocleidomastoid muscle due to increased activity in the diaphragmatic muscle fibers after a period of TMI.

5. 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.

6. 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.

7. TMI reduce the degree of dyspnea reported by patients as MRC scale at the end of the training period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 1, 2015
• Est. primary completion date: November 1, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Inspiratory Muscle Training
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
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.

Locations

Country	Name	City	State
Brazil	Universidade de Santa Cruz do Sul	Santa Cruz do Sul	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
University of Santa Cruz do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle electromyographic activity of the accessory Inspiration		The electromyographic activity will be evaluated during the inspiratory cycles for one minute, It will be evaluated over eight weeks
Secondary	Inspiratory Muscle Training		Will be performed with frequency of three days non-consecutive week, for eight weeks
Secondary	Assessment of lung volumes		will be performed previously to the study and at the end, over eight weeks
Secondary	assessment of respiratory muscle strength		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
Secondary	breathing pattern assessment		will be performed previously to the study and at the end of the same, It will be evaluated over eight weeks