Acute Effects of a Stretching Program of the Rib Cage Muscles on Patients With COPD During Exercise
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
Investigate the effects of stretching the muscles of the rib cage in individuals with COPD during exercise.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 13, 2015
CompletedFirst Posted
Study publicly available on registry
March 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedAugust 11, 2015
August 1, 2015
11 months
February 13, 2015
August 7, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Endurance tolerance as measured by the duration of the exercise
Participants will be followed for the duration of the exercise, an expected average of 10 minutes
Dyspnea as measured by Borg Escale
Participants will be followed for the duration of the exercise, an expected average of 10 minutes
Secondary Outcomes (3)
Diaphragm mobility measured by ultrasound
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
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
Participants will be followed for the duration of the stretching and the exercise, an expected average of 60 minutes
Study Arms (2)
Stretching and Exercise
EXPERIMENTALThis 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
Control and Exercise
SHAM COMPARATORThis 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adriane Cardim, Graduated
Universidade Federal de Pernambuco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Degree in Physical Therapy
Study Record Dates
First Submitted
February 13, 2015
First Posted
March 9, 2015
Study Start
November 1, 2014
Primary Completion
October 1, 2015
Study Completion
November 1, 2015
Last Updated
August 11, 2015
Record last verified: 2015-08