STRETCH OF RESPIRATORY MUSCLES IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Quality of Life Clinical Trial

Official title:

EFFECTS OF RESPIRATORY MUSCLE STRETCH ON THORACOABDOMINAL MECHANIC, FUNCTIONAL CAPACITY, PSYCHOLOGICAL AND SOCIAL ASPECTS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02036762
• Other study ID #: HCFMUSP 1295/09
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 15, 2013
• Last updated: January 13, 2014
• Start date: November 2011
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

THE AIM OF THIS STUDY IS TO TEST IF THE STRETCHING OF THE RESPIRATORY ACCESSORY MUSCLE PROVIDE SOME BENEFIT ON THORACOABDOMINAL MECHANICS, FUNCTIONAL CAPACITY, PSYCHOLOGICAL AND SOCIAL ASPECTS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Description:

PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE WILL BE SUBMITTED TO PASSIVE STRETCHING OF RESPIRATORY MUSCLES AND EXERCISE IN TREADMILL DURING 12 WEEKS, TWICE A WEEK. ONE WEEK AFTER THE TRAINING PERIOD, THE FUNCTIONAL CAPACITY, THE THORACOABDOMINAL MECHANICS AND LEVELS OF ANXIETY AND DEPRESSION WILL BE ASSESSED.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Chronic Obstructive Pulmonary Disease Diagnosis

• Clinical stability

• Absence of previous thoracic surgery

• Absence of other limitations

Exclusion Criteria:

• Copd exacerbation

• Absence greater than three days

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspnea
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Quality of Life
• Respiratory Symptoms
• Signs and Symptoms, Respiratory

Intervention

Other:
• Stretching Exercises
The group submitted to stretching exercises in the respiratory muscles and treadmill exercises

Locations

Country	Name	City	State
Brazil	FOFITO	Sao Paulo
Brazil	Hospital das Clinicas	Sao Paulo
Brazil	Physiotherapy Departament of University of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anxiety and depression	Measured by HADs Scale	One week after the end of training	Yes
Primary	Functional Capacity	Distance obtained (in meters) during six minutes walking test	One week after the end of training	Yes
Secondary	Thoracoabdominal mechanics	The kinematic will be analyzed by optoelectronic plethysmograph during 30 seconds at rest, followed by 30 seconds after 3 minutes cycling without load, followed by 30 seconds after 30 minutes pedaling with load (25% of the calculated maximum watt).	One week after the end of training	Yes