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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01826669
Other study ID # 007
Secondary ID
Status Completed
Phase N/A
First received September 14, 2012
Last updated April 3, 2013
Start date May 2011
Est. completion date December 2011

Study information

Verified date April 2013
Source Universidade Federal de Pernambuco
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date December 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Stretching
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.

Locations

Country Name City State
Brazil UFPE Recife Pernambuco

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Distribution of volume variation of thoracoabdominal wall and electromyographic activity of respiratory muscles 1 hour No
Secondary Respiratory rate, minute volume, expiratory time, inspiratory time, relation inspiratory time/ total time 1 hour No
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