Chronic Obstructive Pulmonary DiseaseNCT01826669
Chest Wall Muscle Stretching and Acute Effects in Chronic Obstructive Pulmonary Disease
A study testing Stretching in people with Chronic Obstructive Pulmonary Disease, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
The study hypothesis is chest wall muscle stretching increase distribution of volume variation of thoracoabdominal wall and reduce electromyographic activity of respiratory muscles in patients with Chronic Obstructive Pulmonary Disease. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Stretching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- May 2011to Dec 2011
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical and functional diagnosis of Chronic obstructive pulmonary disease according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD, 2009),
- forced expiratory volume in one second (FEV1) less than 80% predicted post-bronchodilator;
- clinical stability during the study,
- both sexes,
- age above 40 years,
- body mass index (BMI) between 18.5 and 29.9 kg / m²;
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- smoking history,
- symptoms of cough,
- dyspnea or hypersecretion,
- ex-smokers for at least three months.
Who cannot join
- Disease exacerbation for at least eight weeks,
- patients with other respiratory diseases,
- cardiovascular or osteoarticular and
- participants in pulmonary rehabilitation programs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chest Wall Muscle Stretching and Acute Effects on Volume Variation of Thoracoabdominal Wall and Electromyographic Activity in Chronic Obstructive Pulmonary Disease
The study hypothesis is chest wall muscle stretching increase distribution of volume variation of thoracoabdominal wall and reduce electromyographic activity of respiratory muscles in patients with Chronic Obstructive Pulmonary Disease.
Read the detailed description
Randomized controlled trial involving patients with Chronic Obstructive Pulmonary Disease evaluated before and immediately after a program of stretching muscles of the rib cage or after resting with time similar to the intervention, as volume variation of thoracoabdominal wall by optoelectronic plethysmography and on the electromyographic activity of accessory muscles of respiration.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Stretching
- 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.
StretchingProcedure or surgery
Patients submitted to respiratory muscle stretching related to the increase thoracic mobility. Stretching were performed in the upper trapezius, scalenes, sternocleidomastoids, major pectoral and intercostals. The muscle stretching were performed passively by a single therapist trained and experienced. The subjects were positioned supine or lateral, knees flexed in order to correct the lumbar curve. Stretching occurred during the expiratory phase, leading to muscle maximum length, with two series of ten consecutive incursions for each muscle, with an interval of one minute between series. The patients were properly informed to perform slow exhalations and pursed-lip during stretching.
| Study group | Role | What they receive |
|---|---|---|
| Stretching | Active comparator | The respiratory muscle stretching were developed bilaterally as follows:
* Upper trapezius: head lateral flexion with a hand therapist supports the the occipital region and his shoulder, promotes the stretching;
* Sternocleidomastoid: was stretched with flexion lateral and rotation of the head to the side which hands on the occipital region and in the sternal region;
* Scalene: with one hand on the occipital region and the other in the sternum, the two points was stretched;
* Pectoralis major: the arm was abducted, flexed the forearm and hand was in the occipital region the therapist hands in the arm and in the side of the upper chest, which was stretched craniocaudal direction;
* Intercostal: therapist performs with both hands to mobilize and stretch the ribs in cranial-caudal directions. Receives: Procedure: Stretching |
| Rest | No intervention | COPD patients were not submitted to any intervention, remaining at rest in the same place, position and time period to the treatment group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of volume variation of thoracoabdominal wall and electromyographic activity of respiratory muscles
Measured: 1 hour
Secondary outcomes (1)
Respiratory rate, minute volume, expiratory time, inspiratory time, relation inspiratory time/ total time
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startMay 2011
- Primary completionMay 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafaela Barros de Sa, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826669
- Sponsor's protocol ID
- 007
- Status last verified
- Apr 2013
- First submitted
- 14 Sep 2012
- Last updated
- 8 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chest Wall Muscle Stretching and Acute Effects on Volume Variation of Thoracoabdominal Wall and Electromyographic Activity in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01826669
- Acronym / sponsor ID
- 007
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 8 Apr 2013 (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.
The study hypothesis is chest wall muscle stretching increase distribution of volume variation of thoracoabdominal wall and reduce electromyographic activity of respiratory muscles in patients with Chronic Obstructive Pulmonary Disease.
Detailed description
Randomized controlled trial involving patients with Chronic Obstructive Pulmonary Disease evaluated before and immediately after a program of stretching muscles of the rib cage or after resting with time similar to the intervention, as volume variation of thoracoabdominal wall by optoelectronic plethysmography and on the electromyographic activity of accessory muscles of respiration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stretching | Active comparator | Procedure: StretchingThe respiratory muscle stretching were developed bilaterally as follows: * Upper trapezius: head lateral flexion with a hand therapist supports the the occipital region and his shoulder, promotes the stretching; * Sternocleidomastoid: was stretched with flexion lateral and rotation of the head to the side which hands on the occipital region and in the sternal region; * Scalene: with one hand on the occipital region and the other in the sternum, the two points was stretched; * Pectoralis major: the arm was abducted, flexed the forearm and hand was in the occipital region the therapist hands in the arm and in the side of the upper chest, which was stretched craniocaudal direction; * Intercostal: therapist performs with both hands to mobilize and stretch the ribs in cranial-caudal directions. |
| Rest | No intervention | –COPD patients were not submitted to any intervention, remaining at rest in the same place, position and time period to the treatment group. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- clinical and functional diagnosis of Chronic obstructive pulmonary disease according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD, 2009),
- forced expiratory volume in one second (FEV1) less than 80% predicted post-bronchodilator;
- clinical stability during the study,
- both sexes,
- age above 40 years,
Key exclusion criteria (4 listed)
- Disease exacerbation for at least eight weeks,
- patients with other respiratory diseases,
- cardiovascular or osteoarticular and
- participants in pulmonary rehabilitation programs.
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 |
|---|---|---|
| StretchingPatients submitted to respiratory muscle stretching related to the increase thoracic mobility. Stretching were performed in the upper trapezius, scalenes, sternocleidomastoids, major pectoral and intercostals. The muscle stretching were performed passively by a single therapist trained and experienced. The subjects were positioned supine or lateral, knees flexed in order to correct the lumbar curve. Stretching occurred during the expiratory phase, leading to muscle maximum length, with two series of ten consecutive incursions for each muscle, with an interval of one minute between series. The patients were properly informed to perform slow exhalations and pursed-lip during stretching. | Procedure or surgery | Stretching |
Primary outcome
Distribution of volume variation of thoracoabdominal wall and electromyographic activity of respiratory muscles
Time frame: 1 hour
1 secondary outcome
Respiratory rate, minute volume, expiratory time, inspiratory time, relation inspiratory time/ total time
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stretching in people with Chronic Obstructive Pulmonary Disease, run by Universidade Federal de Pernambuco at 1 site in Brazil.
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 10 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: finished, as of the sponsor's last update on 8 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Distribution of volume variation of thoracoabdominal wall and electromyographic activity of respiratory muscles (time frame: 1 hour). 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 8 Apr 2013.