CopdNCT03022942
Efficacy of Costal Mobilization Techniques and Manual Diaphragm Release Technique in Patients COPD
A study testing GROUP Costal mobilization & Diaphragm Release and GROUP Manual Diaphragm Release in people with Copd and Chest Disorders, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
To evaluate the acute and chronic effects of costal mobilization techniques and diaphragmatic release in chest cavity kinematics, diaphragmatic mobility and functional capacity in patients with chronic obstructive pulmonary disease Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Copd, Chest Disorders, Diaphragmatic Disorder
- What is being tested?
- GROUP Costal mobilization & Diaphragm Release and GROUP Manual Diaphragm Release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2017to 30 Nov 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COPD (spirometry with FEV1 <80% and FEV1 / FVC <0.7) of both sexes, who are not undergoing another physiotherapeutic treatment, from to 21 years of age, clinically stable without exacerbation in the last 6 weeks.
Who cannot join
- Patients with rheumatic or orthopedic diseases;
- Deformities / abnormalities in the spine that compromise the mechanics of the respiratory system;
- Rib fracture for less than 1 year;
- Respiratory co-morbidities;
- History of thoracic or abdominal surgery for less than 1 year;
- Osteoporosis and IMC > 30kg / m²
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Costal Mobilization Techniques and Diaphragm Release in Thoracoabdominal Kinematics, Diaphragm Mobility and Submaximal Functional Capacity in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
To evaluate the acute and chronic effects of costal mobilization techniques and diaphragmatic release in chest cavity kinematics, diaphragmatic mobility and functional capacity in patients with chronic obstructive pulmonary disease
Read the detailed description
Study will be a controlled clinical trial in which participants will be randomized into 2 groups: GROUP A (costal mobilization techniques and Manual Diaphragm Release Technique), GROUP B (Manual Diaphragm Release Technique). After the initial evaluation, participants will undergo six sessions of care according to randomization and will be reevaluated in 3 following situations: immediately after the first session, at the end of treatment and one week after the last session. The evaluation will be performed through Optoelectronic plethysmography , Pollar, Ultrasound and 6-minutes walk test.
- Conditions
- Copd, Chest Disorders, Diaphragmatic Disorder
- Being tested
- GROUP Costal mobilization & Diaphragm Release, GROUP Manual Diaphragm Release
- 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.
GROUP Costal mobilization & Diaphragm ReleaseOther
Also called GROUP Rib Raising & Diaphragm Release, GROUP A
Costal mobilization technique (Rib raising): The patient will be lying. The Therapist supports the last four pulps of both hands at the rib angles, gently traverses the rib angles in the posterior-anterior direction, using the stretcher as a lever to facilitate the elevation of the costal angles. Siting: The Therapist hugs the patient by supporting the ribs of the fingers at the rib angles, gently traverses the rib angles bilaterally in the anterior-lateral direction. Manual Diaphragm Release Technique: The therapist makes manual contact with the underside of the costal border of the common cartilage of the last rib. In the inspiratory phase, the therapist draws the points of contact with both hands in a cephalad direction and slightly Accompanying the movement of the rib cage.
GROUP Manual Diaphragm ReleaseOther
Also called GROUP B
The therapist makes manual contact with the underside of the costal border of the common cartilage of the last rib. In the inspiratory phase, the therapist draws the points of contact with both hands in a cephalad direction and slightly Accompanying the movement of the rib cage.
| Study group | Role | What they receive |
|---|---|---|
| Costal mobilization & Diaphragm Release | Experimental | Costal mobilization. Lying: two sets of ten deep respiratory cycles with one minute interval between sets. Sitting: two series with interval of one minute between them. Manual Diaphragm Release Technique: will be applied during two series of ten deep respiratory cycles, with one minute interval between sets. Receives: Other: GROUP Costal mobilization & Diaphragm Release |
| Manual Diaphragm Release | Active comparator | Manual Diaphragm Release Technique: will be applied during two series of ten deep respiratory cycles, with one minute interval between sets. Receives: Other: GROUP Manual Diaphragm Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility of the thoracic cage
Will be measured by optoelectronic plestimography
Measured: Three weeks total: Thirty minutes after the first intervention, after two weeks of intervention and after one week without treatment (follow up)
Secondary outcomes (3)
Diaphragma mobility
Will be measured with ultrasonography
Measured: Three weeks total: Thirty minutes after the first intervention, after two weeks of intervention and after one week without treatment (follow up)
functional capacity
Will be measured six minute walk test
Measured: Three weeks total: after two weeks of intervention and after one week without treatment (follow up)
heart rate variability
Will be measured Pollar
Measured: 1 day: before and after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start1 Feb 2017
- Primary completion31 Jan 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HELENA MEDEIROS ROCHA, Universidade Federal de Pernambuco
- Investigators
- HELENA M ROCHA, Principal investigator, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022942
- Sponsor's protocol ID
- Lacap UFPE
- Status last verified
- Feb 2025
- First submitted
- 22 Dec 2016
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Costal Mobilization Techniques and Diaphragm Release in Thoracoabdominal Kinematics, Diaphragm Mobility and Submaximal Functional Capacity in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03022942
- Acronym / sponsor ID
- Lacap UFPE
- Conditions
- Copd, Chest Disorders, Diaphragmatic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 18 Jan 2017 (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.
To evaluate the acute and chronic effects of costal mobilization techniques and diaphragmatic release in chest cavity kinematics, diaphragmatic mobility and functional capacity in patients with chronic obstructive pulmonary disease
Detailed description
Study will be a controlled clinical trial in which participants will be randomized into 2 groups: GROUP A (costal mobilization techniques and Manual Diaphragm Release Technique), GROUP B (Manual Diaphragm Release Technique). After the initial evaluation, participants will undergo six sessions of care according to randomization and will be reevaluated in 3 following situations: immediately after the first session, at the end of treatment and one week after the last session. The evaluation will be performed through Optoelectronic plethysmography , Pollar, Ultrasound and 6-minutes walk test.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Costal mobilization & Diaphragm Release | Experimental | Other: GROUP Costal mobilization & Diaphragm ReleaseCostal mobilization. Lying: two sets of ten deep respiratory cycles with one minute interval between sets. Sitting: two series with interval of one minute between them. Manual Diaphragm Release Technique: will be applied during two series of ten deep respiratory cycles, with one minute interval between sets. |
| Manual Diaphragm Release | Active comparator | Other: GROUP Manual Diaphragm ReleaseManual Diaphragm Release Technique: will be applied during two series of ten deep respiratory cycles, with one minute interval between sets. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of COPD (spirometry with FEV1 <80% and FEV1 / FVC <0.7) of both sexes, who are not undergoing another physiotherapeutic treatment, from to 21 years of age, clinically stable without exacerbation in the last 6 weeks.
Key exclusion criteria (6 listed)
- Patients with rheumatic or orthopedic diseases;
- Deformities / abnormalities in the spine that compromise the mechanics of the respiratory system;
- Rib fracture for less than 1 year;
- Respiratory co-morbidities;
- History of thoracic or abdominal surgery for less than 1 year;
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 |
|---|---|---|
| GROUP Costal mobilization & Diaphragm ReleaseAlso: GROUP Rib Raising & Diaphragm Release, GROUP ACostal mobilization technique (Rib raising): The patient will be lying. The Therapist supports the last four pulps of both hands at the rib angles, gently traverses the rib angles in the posterior-anterior direction, using the stretcher as a lever to facilitate the elevation of the costal angles. Siting: The Therapist hugs the patient by supporting the ribs of the fingers at the rib angles, gently traverses the rib angles bilaterally in the anterior-lateral direction. Manual Diaphragm Release Technique: The therapist makes manual contact with the underside of the costal border of the common cartilage of the last rib. In the inspiratory phase, the therapist draws the points of contact with both hands in a cephalad direction and slightly Accompanying the movement of the rib cage. | Other | Costal mobilization & Diaphragm Release |
| GROUP Manual Diaphragm ReleaseAlso: GROUP BThe therapist makes manual contact with the underside of the costal border of the common cartilage of the last rib. In the inspiratory phase, the therapist draws the points of contact with both hands in a cephalad direction and slightly Accompanying the movement of the rib cage. | Other | Manual Diaphragm Release |
Primary outcome
Mobility of the thoracic cage
Time frame: Three weeks total: Thirty minutes after the first intervention, after two weeks of intervention and after one week without treatment (follow up)
Will be measured by optoelectronic plestimography
3 secondary outcomes
Diaphragma mobility
Time frame: Three weeks total: Thirty minutes after the first intervention, after two weeks of intervention and after one week without treatment (follow up)
functional capacity
Time frame: Three weeks total: after two weeks of intervention and after one week without treatment (follow up)
heart rate variability
Time frame: 1 day: before and after the intervention
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 27 Feb 2025.
- Individual participant dataSharing planned: No
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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.
HELENA M ROCHA principal investigator
Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GROUP Costal mobilization & Diaphragm Release and GROUP Manual Diaphragm Release in people with Copd and Chest Disorders, 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 1 inclusion and 6 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 27 Feb 2025. 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?
Mobility of the thoracic cage (time frame: Three weeks total: Thirty minutes after the first intervention, after two weeks of intervention and after one week without treatment (follow up)). 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 27 Feb 2025.