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STRETCH OF RESPIRATORY MUSCLES IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Primary Purpose

Dyspnea, Quality of Life, Respiratory Symptoms

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Stretching Exercises
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspnea focused on measuring Chronic Obstructive Pulmonary Disease, Thoracoabdominal Mechanics, Functional capacity, Quality of life

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • FOFITO
  • Hospital das Clinicas
  • Physiotherapy Departament of University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Treatment Group

Control Group

Arm Description

The group submitted to stretching exercises in the respiratory muscles and treadmill exercises

The control group received stretching exercises in the fist and ankle muscles and treadmill exercises

Outcomes

Primary Outcome Measures

Functional Capacity
Distance obtained (in meters) during six minutes walking test

Secondary Outcome Measures

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).

Full Information

First Posted
August 15, 2013
Last Updated
January 13, 2014
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02036762
Brief Title
STRETCH OF RESPIRATORY MUSCLES IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Official Title
EFFECTS OF RESPIRATORY MUSCLE STRETCH ON THORACOABDOMINAL MECHANIC, FUNCTIONAL CAPACITY, PSYCHOLOGICAL AND SOCIAL ASPECTS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea, Quality of Life, Respiratory Symptoms
Keywords
Chronic Obstructive Pulmonary Disease, Thoracoabdominal Mechanics, Functional capacity, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Active Comparator
Arm Description
The group submitted to stretching exercises in the respiratory muscles and treadmill exercises
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
The control group received stretching exercises in the fist and ankle muscles and treadmill exercises
Intervention Type
Other
Intervention Name(s)
Stretching Exercises
Intervention Description
The group submitted to stretching exercises in the respiratory muscles and treadmill exercises
Primary Outcome Measure Information:
Title
Functional Capacity
Description
Distance obtained (in meters) during six minutes walking test
Time Frame
One week after the end of training
Secondary Outcome Measure Information:
Title
Thoracoabdominal mechanics
Description
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).
Time Frame
One week after the end of training
Other Pre-specified Outcome Measures:
Title
Anxiety and depression
Description
Measured by HADs Scale
Time Frame
One week after the end of training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celso Carvalho, Dr.
Organizational Affiliation
Physiotherapy Departament of University of São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
FOFITO
City
Sao Paulo
ZIP/Postal Code
05360000
Country
Brazil
Facility Name
Hospital das Clinicas
City
Sao Paulo
Country
Brazil
Facility Name
Physiotherapy Departament of University of São Paulo
City
São Paulo
ZIP/Postal Code
05360-000
Country
Brazil

12. IPD Sharing Statement

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STRETCH OF RESPIRATORY MUSCLES IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE

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