Inspiratory Muscle Training and Respiratory Electromyographic Activity in COPD

NCT02014155 | Completed

• 1 other identifier: UNISC_001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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:

1. 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. 2.TMI alters the breathing pattern in COPD patients regardless of whether they were entered into a PR program.
3. 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. 4.There is decreased activity of the sternocleidomastoid muscle due to increased activity in the diaphragmatic muscle fibers after a period of TMI.
5. 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. 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. 7.TMI reduce the degree of dyspnea reported by patients as MRC scale at the end of the training period.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease,

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Inspiratory Muscle Training

  Will be performed with frequency of three days non-consecutive week, for eight weeks

• Assessment of lung volumes

  will be performed previously to the study and at the end, over eight weeks

• 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

• breathing pattern assessment

  will be performed previously to the study and at the end of the same, It will be evaluated over eight weeks

Study Arms (4)

Group Pulmonary Rehabilitation

EXPERIMENTAL

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.

Other: Pulmonary Rehabilitation

Group TMI + Pulmonary Rehabilitation

EXPERIMENTAL

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.

Other: Inspiratory Muscle Training; Other: Pulmonary Rehabilitation

Control Group

EXPERIMENTAL

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

Other: Inspiratory Muscle Training

COPD group not rehabilitation

EXPERIMENTAL

Other: Inspiratory Muscle Training

Interventions

Inspiratory Muscle Training OTHER

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.

COPD group not rehabilitation; Control Group; Group TMI + Pulmonary Rehabilitation

Pulmonary Rehabilitation OTHER

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.

Group Pulmonary Rehabilitation; Group TMI + Pulmonary Rehabilitation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Santa Cruz do Sul: lead

Study Sites (1)

Universidade de Santa Cruz do Sul

Santa Cruz do Sul, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dulciane N Paiva, Doctor

  University of Santa Cruz do Sul

  PRINCIPAL INVESTIGATOR

• Diogo F Bordin, Academic

  University of Santa Cruz do Sul

  PRINCIPAL INVESTIGATOR

• Dannuey M Cardoso, Master

  University of Santa Cruz do Sul

  STUDY DIRECTOR

• Andrea LG da Silva, Doctor

  University of Santa Cruz do Sul

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Initiation Scholarship

Study Record Dates

• First Submitted: November 3, 2013
• First Posted: December 18, 2013
• Study Start: August 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: January 1, 2015
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

BR (1)