- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03022942
Efficacy of Costal Mobilization Techniques and Manual Diaphragm Release Technique in Patients COPD
February 24, 2025 updated by: HELENA MEDEIROS ROCHA, Universidade Federal de Pernambuco
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pernambuco
-
Recife, Pernambuco, Brazil, 50670-901
- Universidade Federal de Pernambuco
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Costal mobilization & Diaphragm Release
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.
|
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.
Other Names:
|
|
Active Comparator: Manual Diaphragm Release
Manual Diaphragm Release Technique: will be applied during two series of ten deep respiratory cycles, with one minute interval between sets.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Three weeks total: Thirty minutes after the first intervention, after two weeks of intervention and after one week without treatment (follow up)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Will be measured with ultrasonography
|
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)
|
Will be measured six minute walk test
|
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
|
Will be measured Pollar
|
1 day: before and after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: HELENA M ROCHA, Universidade Federal de Pernambuco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2017
Primary Completion (Actual)
January 31, 2018
Study Completion (Actual)
November 30, 2018
Study Registration Dates
First Submitted
December 22, 2016
First Submitted That Met QC Criteria
January 12, 2017
First Posted (Estimated)
January 18, 2017
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 24, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lacap UFPE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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