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

NCT ID: NCT03417908

Last Updated: 2018-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-04

Study Completion Date

2018-12-14

Brief Summary

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

Detailed Description

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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.

Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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COPD - PNF

COPD - PNF

Group Type ACTIVE_COMPARATOR

PNF

Intervention Type PROCEDURE

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.

COPD - sham

COPD - sham

Group Type SHAM_COMPARATOR

Sham

Intervention Type PROCEDURE

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.

Individuals Without COPD - PNF

Individuals Without COPD - PNF

Group Type ACTIVE_COMPARATOR

PNF

Intervention Type PROCEDURE

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.

Individuals Without COPD - sham

Individuals Without COPD - sham

Group Type SHAM_COMPARATOR

Sham

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of Rio Grande do Sul

OTHER

Sponsor Role collaborator

Universidade Federal do Pampa

OTHER

Sponsor Role lead

Responsible Party

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Anelise Dumke

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anelise Dumke

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Marli M. Knorst

Role: STUDY_DIRECTOR

Federal University of Rio Grande do Sul

Locations

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Anelise Dumke

Uruguaiana, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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09-411

Identifier Type: -

Identifier Source: org_study_id

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