- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02383277
Acute Effects of a Stretching Program of the Rib Cage Muscles on Patients With COPD During Exercise
August 7, 2015 updated by: Adriane Borba Cardim, Universidade Federal de Pernambuco
Acute Effects of a Stretching Program of the Rib Cage Muscles on the Regional Distribution of Ventilation and the Diaphragmatic Mobility of Patients With COPD During Exercise: a Randomized Crossover Clinical Trial
Investigate the effects of stretching the muscles of the rib cage in individuals with COPD during exercise.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
To investigate the effects of a stretching program for the muscles of the rib cage or control in patients with COPD during exercise and / or the immediate post-exercise, using the following parameters:
- Tidal volume (VT), respiratory rate (RR), minute volume (MV), inspiratory time (Tins) and expiratory (T exp).
- Change in volumes of total and regional chest magazines (pulmonary rib cage, abdominal rib cage and abdomen).
- Diaphragmatic mobility.
- electrical muscle activity
- endurance time.
- Dyspnea sensation.
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
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
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Smoking history, occupational or environmental exposure to pollutants and / or symptoms of cough, dyspnea or hypersecretion;
- FEV1 <80% predicted and post-bronchodilator FEV1 / FVC <70% to confirm the diagnosis of airway obstruction not fully reversible bronchodilator therapy;
- Absence of co-morbidities that does not allow the realization of stress (hypertension, severe pulmonary hypertension, myocardial infarction, congestive heart failure, severe dyspnoea);
- Preserved cognitive functioning;
- Sedentary
- Clinically stable during the study period.
Exclusion Criteria:
- Patients with cognitive, hearing or visual deficit;
- Changes in the neuro-musculo-skeletal system which endangers or impairs the assessment;
- Obese
- Not be able to achieve at least three stages of the incremental test.
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: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Stretching and Exercise
This group undergo a session of stretching aiming flexibility of the rib cage and later at an exercise test with constant load up to the limit of tolerance for exercise bike
|
Stretching of the rib cage muscles
Constant load exercise on a bike
|
|
Sham Comparator: Control and Exercise
This group will carry out the exercise test with constant load up to the limit of tolerance for exercise bike after a period of rest under the same environmental conditions and the experimental group time.
During this time the therapist will place their hands but not performing the stretch.
|
Constant load exercise on a bike
Rest without stretching (sham)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Endurance tolerance as measured by the duration of the exercise
Time Frame: Participants will be followed for the duration of the exercise, an expected average of 10 minutes
|
Participants will be followed for the duration of the exercise, an expected average of 10 minutes
|
|
Dyspnea as measured by Borg Escale
Time Frame: Participants will be followed for the duration of the exercise, an expected average of 10 minutes
|
Participants will be followed for the duration of the exercise, an expected average of 10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Diaphragm mobility measured by ultrasound
Time Frame: Participants will be followed for the duration of the stretching and the exercise, an expected average of 60 minutes
|
Participants will be followed for the duration of the stretching and the exercise, an expected average of 60 minutes
|
|
Volumes of the chest wall measured by pletismography optoelectronic
Time Frame: Participants will be followed for the duration of the stretching and the exercise, an expected average of 60 minutes
|
Participants will be followed for the duration of the stretching and the exercise, an expected average of 60 minutes
|
|
Muscle electrical activity measured by surface electromyography
Time Frame: Participants will be followed for the duration of the stretching and the exercise, an expected average of 60 minutes
|
Participants will be followed for the duration of the stretching and the exercise, an expected average of 60 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Adriane Cardim, Graduated, Universidade Federal de Pernambuco
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, 2014
Primary Completion (Anticipated)
October 1, 2015
Study Completion (Anticipated)
November 1, 2015
Study Registration Dates
First Submitted
February 13, 2015
First Submitted That Met QC Criteria
March 2, 2015
First Posted (Estimate)
March 9, 2015
Study Record Updates
Last Update Posted (Estimate)
August 11, 2015
Last Update Submitted That Met QC Criteria
August 7, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UFPEFT2015
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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