Clinical trial NCT02014155: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease,
Lead sponsor: University of Santa Cruz do Sul
Sponsor class: OTHER
First posted: 2013-12-18
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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. 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.


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.

Primary outcomes:
measure: Muscle electromyographic activity of the accessory Inspiration
timeFrame: The electromyographic activity will be evaluated during the inspiratory cycles for one minute, It will be evaluated over eight weeks
Secondary outcomes:
measure: Inspiratory Muscle Training
timeFrame: Will be performed with frequency of three days non-consecutive week, for eight weeks
measure: Assessment of lung volumes
timeFrame: will be performed previously to the study and at the end, over eight weeks
measure: assessment of respiratory muscle strength
timeFrame: 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
measure: breathing pattern assessment
timeFrame: will be performed previously to the study and at the end of the same, It will be evaluated over eight weeks
Other outcomes:
Locations:
city: Santa Cruz do Sul
country: Brazil
facility: Universidade de Santa Cruz do Sul
state: Rio Grande do Sul
Study officials:
affiliation: University of Santa Cruz do Sul
name: Dulciane N Paiva, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Santa Cruz do Sul
name: Diogo F Bordin, Academic
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Santa Cruz do Sul
name: Dannuey M Cardoso, Master
role: STUDY_DIRECTOR
affiliation: University of Santa Cruz do Sul
name: Andrea LG da Silva, Doctor
role: STUDY_DIRECTOR
References: