- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01826669
Chest Wall Muscle Stretching and Acute Effects in Chronic Obstructive Pulmonary Disease
April 3, 2013 updated by: Rafaela Barros de Sa, Universidade Federal de Pernambuco
Chest Wall Muscle Stretching and Acute Effects on Volume Variation of Thoracoabdominal Wall and Electromyographic Activity in Chronic Obstructive Pulmonary Disease
The study hypothesis is chest wall muscle stretching increase distribution of volume variation of thoracoabdominal wall and reduce electromyographic activity of respiratory muscles in patients with Chronic Obstructive Pulmonary Disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Randomized controlled trial involving patients with Chronic Obstructive Pulmonary Disease evaluated before and immediately after a program of stretching muscles of the rib cage or after resting with time similar to the intervention, as volume variation of thoracoabdominal wall by optoelectronic plethysmography and on the electromyographic activity of accessory muscles of respiration.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pernambuco
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Recife, Pernambuco, Brazil, 50740560
- UFPE
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- clinical and functional diagnosis of Chronic obstructive pulmonary disease according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD, 2009),
- forced expiratory volume in one second (FEV1) less than 80% predicted post-bronchodilator;
- clinical stability during the study,
- both sexes,
- age above 40 years,
- body mass index (BMI) between 18.5 and 29.9 kg / m²;
- smoking history,
- symptoms of cough,
- dyspnea or hypersecretion,
- ex-smokers for at least three months.
Exclusion Criteria:
- Disease exacerbation for at least eight weeks,
- patients with other respiratory diseases,
- cardiovascular or osteoarticular and
- participants in pulmonary rehabilitation programs.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Stretching
The respiratory muscle stretching were developed bilaterally as follows:
|
Patients submitted to respiratory muscle stretching related to the increase thoracic mobility.
Stretching were performed in the upper trapezius, scalenes, sternocleidomastoids, major pectoral and intercostals.
The muscle stretching were performed passively by a single therapist trained and experienced.
The subjects were positioned supine or lateral, knees flexed in order to correct the lumbar curve.
Stretching occurred during the expiratory phase, leading to muscle maximum length, with two series of ten consecutive incursions for each muscle, with an interval of one minute between series.
The patients were properly informed to perform slow exhalations and pursed-lip during stretching.
|
No Intervention: Rest
COPD patients were not submitted to any intervention, remaining at rest in the same place, position and time period to the treatment group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Distribution of volume variation of thoracoabdominal wall and electromyographic activity of respiratory muscles
Time Frame: 1 hour
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Respiratory rate, minute volume, expiratory time, inspiratory time, relation inspiratory time/ total time
Time Frame: 1 hour
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
September 14, 2012
First Submitted That Met QC Criteria
April 3, 2013
First Posted (Estimate)
April 8, 2013
Study Record Updates
Last Update Posted (Estimate)
April 8, 2013
Last Update Submitted That Met QC Criteria
April 3, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 007
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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