- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03417908
Respiratory Muscle Stretching Effect on Functional and Electromyographic Parameters of Patients With and Without COPD
Effects of Proprioceptive Neuromuscular Facilitation Applied to the Accessory Respiratory Muscles on Functional and Electromyographic Parameters in Patients With and Without COPD
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rio Grande Do Sul
-
Uruguaiana, Rio Grande Do Sul, Brazil, 97502-765
- Anelise Dumke
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: COPD - 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 Comparator: COPD - 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.
|
Active Comparator: Individuals Without COPD - 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 Comparator: Individuals Without COPD - 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in inspiratory capacity
Time Frame: One day
|
Change in inspiratory capacity
|
One day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in maximal respiratory pressure (MIP and MEP)
Time Frame: One day
|
Change in maximal respiratory pressure (MIP and MEP)
|
One day
|
Change in electromyographic activity of accessory respiratory muscles
Time Frame: One Day
|
Change in electromyographic activity of accessory respiratory muscles
|
One Day
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anelise Dumke, Federal University of Rio Grande do Sul
- Study Director: Marli M. Knorst, Federal University of Rio Grande do Sul
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 09-411
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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