STRETCH OF RESPIRATORY MUSCLES IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE

January 13, 2014 updated by: Juliano Wada, University of Sao Paulo

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2
  • Phase 3

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

  • Brazil
      • Sao Paulo, Brazil, 05360000
        • FOFITO
      • Sao Paulo, Brazil
        • Hospital das Clinicas
      • São Paulo, Brazil, 05360-000
        • Physiotherapy Departament of University of São Paulo

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 to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Treatment Group
The group submitted to stretching exercises in the respiratory muscles and treadmill exercises
Other: Stretching Exercises
The group submitted to stretching exercises in the respiratory muscles and treadmill exercises
SHAM_COMPARATOR: Control Group
The control group received stretching exercises in the fist and ankle muscles and treadmill exercises
Other: Stretching Exercises
The group submitted to stretching exercises in the respiratory muscles and treadmill exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Capacity
Time Frame: One week after the end of training
Distance obtained (in meters) during six minutes walking test
One week after the end of training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thoracoabdominal mechanics
Time Frame: One week after the end of training
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety and depression
Time Frame: One week after the end of training
Measured by HADs Scale
One week after the end of training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Study Director: Celso Carvalho, Dr., Physiotherapy Departament of University of São Paulo

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

November 1, 2011

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

August 15, 2013

First Submitted That Met QC Criteria

January 13, 2014

First Posted (ESTIMATE)

January 15, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 15, 2014

Last Update Submitted That Met QC Criteria

January 13, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCFMUSP 1295/09

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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