Acute Effects of a Stretching Program of the Rib Cage Muscles on Patients With COPD During Exercise
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stretching
Control
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Stretching and Exercise
Control and Exercise
Arm Description
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
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.
Outcomes
Primary Outcome Measures
Endurance tolerance as measured by the duration of the exercise
Dyspnea as measured by Borg Escale
Secondary Outcome Measures
Diaphragm mobility measured by ultrasound
Volumes of the chest wall measured by pletismography optoelectronic
Muscle electrical activity measured by surface electromyography
Full Information
NCT ID
NCT02383277
First Posted
February 13, 2015
Last Updated
August 7, 2015
Sponsor
Universidade Federal de Pernambuco
1. Study Identification
Unique Protocol Identification Number
NCT02383277
Brief Title
Acute Effects of a Stretching Program of the Rib Cage Muscles on Patients With COPD During Exercise
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
November 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Investigate the effects of stretching the muscles of the rib cage in individuals with COPD during exercise.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stretching and Exercise
Arm Type
Experimental
Arm Description
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
Arm Title
Control and Exercise
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Stretching
Intervention Description
Stretching of the rib cage muscles
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Rest without stretching (sham)
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Constant load exercise on a bike
Primary Outcome Measure Information:
Title
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
Title
Dyspnea as measured by Borg Escale
Time Frame
Participants will be followed for the duration of the exercise, an expected average of 10 minutes
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriane Cardim, Graduated
Organizational Affiliation
Universidade Federal de Pernambuco
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Acute Effects of a Stretching Program of the Rib Cage Muscles on Patients With COPD During Exercise
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