Respiratory Muscle Stretching Effect on Functional and Electromyographic Parameters of Patients With and Without COPD

COPD Clinical Trial

Official title:

Effects of Proprioceptive Neuromuscular Facilitation Applied to the Accessory Respiratory Muscles on Functional and Electromyographic Parameters in Patients With and Without COPD

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03417908
• Other study ID #: 09-411
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 4, 2017
• Est. completion date: December 14, 2018

Study information

• Verified date: February 2018
• Source: Universidade Federal do Pampa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the activation of accessory respiratory muscles and the effects of stretching these muscles in patients with COPD.

Description:

All subjects (sixty men) will perform spirometry, measure of inspiratory capacity (IC) and maximal inspiratory and expiratory pressures (MIP and MEP). Baseline blood pressure (BP), respiratory rate (RR), heart rate (HR), sensation of dyspnea (Borg Scale) and oxygen saturation (pulse oximetry, SpO2) will be collected prior to the performance of pulmonary function tests.

The electrical activity of the scalene (ESC), sternocleidomastoid (SCM) and external intercostal muscles (INTER) will be measured by surface electromyography (sEMG) at rest and during the maneuvers of IC, MIP and MEP.

Control group: The control group will perform isotonic concentric contraction of the biceps (two sets of five push-ups elbow in both arms) with the individual sitting in a chair with back support.

Intervention group: The contract-relax method of proprioceptive neuromuscular facilitation (PNF) technique will be used for stretching of ESC, ECM and external intercostals muscles. The contraction of agonist muscles against the resistance imposed by the physiotherapist (isometric contraction) is maintained for 6 seconds. After that, the patient will be asked to relax the muscles for 6 seconds without losing range of motion, and then the muscle will be lengthened. This procedure is repeated until the maximum amplitude of motion of the neck and upper limb is reached. The stretching will be performed on the right and left sides of the body.

Statistical analysis will be carried out with the Statistical Package for the Social Sciences, version 18.0 (SPSS Inc., Chicago, IL, USA). Normality of data distribution will be assessed by the Shapiro-Wilk test.

Values will be presented as mean ± standard deviation (SD) or median (25-75%). To compare the differences between the baseline characteristics between the groups the t test for independent samples will be used. The effect of the intervention will be evaluated by paired t test. For the analysis of the electromyographic signal will be use the Wilcoxon T test. Statistical significance is accepted at p < 0.05.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 14, 2018
• Est. primary completion date: December 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Control group: Men without respiratory symptoms and lung disease, with normal spirometry.

• Interventional group: Men diagnosed with severe to very severe COPD (forced expiratory volume in one second / forced vital capacity - FEV1/FVC <0.7 and FEV1 <50% predicted after bronchodilator use); clinically stable over the past 4 weeks.

Exclusion Criteria:

• History of fracture in the spine and / or upper limb

• Herniated disc

• Connective tissue disease

• Ischemic heart disease or uncontrolled hypertension

• Obesity (BMI> 30 kg/m2)

• Aortic aneurysm

• Recent abdominal or thoracic surgery

• Glaucoma

• Retinal detachment

Related Conditions & MeSH terms

• COPD

Intervention

Procedure:
• PNF
The contract-relax method of proprioceptive neuromuscular facilitation (PNF) technique will be used for stretching of ESC, ECM and external intercostals muscles. The contraction of agonist muscles against the resistance imposed by the physiotherapist (isometric contraction) will be maintained for 6 seconds. After that, the patient is oriented to relax the muscles for 6 seconds without losing range of motion, and then the muscle will be lengthened. This procedure is repeated until the maximum amplitude of motion of the neck and upper limb is reached. The stretching will be performed on the right and left sides of the body.
• Sham
Isotonic concentric contraction of the biceps (two sets of five push-ups elbow in both arms) with the individual sitting in a chair with back support.

Locations

Country	Name	City	State
Brazil	Anelise Dumke	Uruguaiana	Rio Grande Do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal do Pampa	Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in inspiratory capacity	Change in inspiratory capacity	One day
Secondary	Change in maximal respiratory pressure (MIP and MEP)	Change in maximal respiratory pressure (MIP and MEP)	One day
Secondary	Change in electromyographic activity of accessory respiratory muscles	Change in electromyographic activity of accessory respiratory muscles	One Day