Pulmonary Disease, Chronic ObstructiveNCT02383277
Acute Effects of a Stretching Program of the Rib Cage Muscles on Patients With COPD During Exercise
A study testing Stretching and Exercise in people with Pulmonary Disease, Chronic Obstructive, run by Universidade Federal de Pernambuco.
Trial summary
Investigate the effects of stretching the muscles of the rib cage in individuals with COPD during exercise. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Stretching and Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
Investigate the effects of stretching the muscles of the rib cage in individuals with COPD during exercise.
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Stretching, Control, Exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StretchingOther
Stretching of the rib cage muscles
ControlOther
Rest without stretching (sham)
ExerciseOther
Constant load exercise on a bike
| Study group | Role | What they receive |
|---|---|---|
| Stretching and Exercise | Experimental | 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 Receives: Other: Stretching; Other: Exercise |
| Control and Exercise | Sham comparator | 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. Receives: Other: Control; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance tolerance as measured by the duration of the exercise
Measured: Participants will be followed for the duration of the exercise, an expected average of 10 minutes
Dyspnea as measured by Borg Escale
Measured: Participants will be followed for the duration of the exercise, an expected average of 10 minutes
Secondary outcomes (3)
Diaphragm mobility measured by ultrasound
Measured: 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
Measured: 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
Measured: Participants will be followed for the duration of the stretching and the exercise, an expected average of 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startNov 2014
- Primary completionOct 2015 (estimated)
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adriane Borba Cardim, Universidade Federal de Pernambuco
- Investigators
- Adriane Cardim, Graduated, Principal investigator, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383277
- Sponsor's protocol ID
- UFPEFT2015
- Status last verified
- Aug 2015
- First submitted
- 13 Feb 2015
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02383277
- Acronym / sponsor ID
- UFPEFT2015
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stretching and Exercise | Experimental | Other: Stretching, Other: ExerciseThis 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 comparator | Other: Control, Other: ExerciseThis 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StretchingStretching of the rib cage muscles | Other | Stretching and Exercise |
| ControlRest without stretching (sham) | Other | Control and Exercise |
| ExerciseConstant load exercise on a bike | Other | Control and Exercise, Stretching and Exercise |
Primary outcome
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
Dyspnea as measured by Borg Escale
Time frame: Participants will be followed for the duration of the exercise, an expected average of 10 minutes
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriane Cardim, Graduated principal investigator
Universidade Federal de Pernambuco
Questions about this trial
What is this clinical trial studying?
A study testing Stretching and Exercise in people with Pulmonary Disease, Chronic Obstructive, run by Universidade Federal de Pernambuco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2015.