COPDNCT02212184
Diaphragm Release Manual Technique Efficacy in COPD Patients
A study testing Manual Diaphragm Release Technique in people with COPD, run by Helga Cecília Muniz de Souza at 1 site in Brazil.
Trial summary
The aims of this study are to evaluate the effects of Diaphragm Release Manual Technique on diaphragm mobility, chest wall kinematics and functional capacity of COPD patients. Methods: Randomized controlled trial (double blinded) with COPD patients, allocated in two group: intervention (IG) who will receive the… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Manual Diaphragm Release Technique
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2014to Dec 2014
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CPOD patients
- ex-smokers
- clinically stable patients (no exacerbation in the previous 6 weeks)
- forced expiratory volume in one second (FEV1) < than 80% predicted
- FEV1/FVC ≤ 0.7, post bronchodilator
Who cannot join
- cardiopulmonary diseases
- BMI > 30.0 kg/m2
- History of thoracic surgery
- Denial to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diaphragm Release Manual Technique Efficacy on Diaphragmatic Mobility, Respiratory Muscle Strength and Exercise Performance in COPD Patients: a Randomized Controlled Trial
The aims of this study are to evaluate the effects of Diaphragm Release Manual Technique on diaphragm mobility, chest wall kinematics and functional capacity of COPD patients. Methods: Randomized controlled trial (double blinded) with COPD patients, allocated in two group: intervention (IG) who will receive the Diaphragm Release manual technique on 6 non-consecutive sessions and control group (CG), who will receive a sham protocol (light touch) with the same parameters of IG. Outcomes will be evaluated as: immediate and post treatment effects (after 1 and 6 sessions respectively). The primary outcome analysed will be the diaphragm displacement (ultrasonography evaluation) and secondary outcomes will comprise abdominal and chest wall kinematics.
- Conditions
- COPD
- Being tested
- Manual Diaphragm Release Technique, Manual Diaphragm release technique (sham)
- Keywords
- Diaphragm, COPD, Musculoskeletal Manipulations, Ultrasonography, Optoelectronic Plethysmography.
- 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.
Manual Diaphragm Release TechniqueOther
Also called Manual Diaphragm Stretching Technique
The therapist performs manual contact (pisiform, ulnar edge and the last three fingers) with the underside of the costal cartilage of the 7th, 8th, 9th and 10th rib, and guiding forearms toward the shoulders of the corresponding side. During inspiration, pulls the points of contact with both hands, in the direction of the head, accompanying the elevation movement of the ribs. During exhalation, deepens contact toward the inner costal, maintaining resistance. 2 sets x 10 breaths (1 min interval). Treatment will last two weeks (6 sessions) All patients will undertake four evaluations throughout treatment: Baseline Day 1 and post Day 1; Baseline Day 6 and post Day 6.
Manual Diaphragm release technique (sham)Other
Manual Diaphragm release technique (sham) In attempt to execute the sham protocol the therapist performs manual contact (pisiform, ulnar edge and the last three fingers) with the underside of the costal cartilage of the 7th, 8th, 9th and 10th rib. The therapist will hold only light touch in the landmarks, without exerting pressure or traction. The maneuver will be performed in two sets of ten deep breaths, with an one minute interval between them.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Sham comparator | Manual Diaphragm release technique (sham) In attempt to execute the sham protocol the therapist performs manual contact (pisiform, ulnar edge and the last three fingers) with the underside of the costal cartilage of the 7th, 8th, 9th and 10th rib. The therapist will hold only light touch in the landmarks, without exerting pressure or traction. The maneuver will be performed in two sets of ten deep breaths, with an one minute interval between them. Receives: Other: Manual Diaphragm release technique (sham) |
| Intevention Group | Experimental | All patients will receive the Manual Diaphragm Release Technique, during 6 days of treatment. They will undertake four evaluations throughout treatment: before and immediately after the Day 1 (Baseline 1 and Post 1) and before and after Day 6 (Baseline 6 and Post 6).
In the other Days (2nd to 5th) patients will only receive the intervention and won't be evaluated. Receives: Other: Manual Diaphragm Release Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm mobility
To evaluate diaphragmatic mobility a high-resolution ultrasound SonoaceR3 (Samsung Medison - South Korea) with a 3.5 MHz convex transducer will be used. Volunteers will remain in a supine position and receive verbal command to perform Inspiratory capacity maneuvers (IC), and the measurement of each curve referring to the diaphragmatic displacement (in mm) will be performed immediately after obtaining the images. The maneuvers will be repeated until obtaining 5 satisfactory images. The average of the three highest values not differing by more than 10% between their values should be accepted.
Measured: Diaphragm mobility at first session and after two weeks of treatment.
Secondary outcomes (1)
Compartmental Chest wall volume
Compartmental Chest wall volume will be measured by Opto-electronic Plethysmograph (OEP) (BTS Bioengineering, Italy) with 89 reflective markers placed on volunteer´s skin surface using a hypoallergenic adhesive on specific anatomical points of the chest wall and abdomen. Thus, changes in chest wall volumes are going to be calculated, allowing to acquire total chest wall volume (Vcw) and the division into three compartments, namely: pulmonary rib cage (Rc,p), abdominal rib cage (Rc,a) and abdomen (Ab) during quiet breathing, inspiratory capacity (IC) and vital capacity (VC), maneuvers.
Measured: Compartmental Chest wall volume evaluated by Opto-electronic Plethysmograph at the first session and after two weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helga Cecília Muniz de Souza
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal de Pernambuco
- Responsible party
- Sponsor-investigator, Helga Cecília Muniz de Souza, Universidade Federal de Pernambuco
- Investigators
- Armele D de Andrade, Post Doctor, Study director, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212184
- Sponsor's protocol ID
- Manual Therapy in COPD
- Status last verified
- Nov 2015
- First submitted
- 12 Jun 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rocha T, Souza H, Brandao DC, Rattes C, Ribeiro L, Campos SL, Aliverti A, de Andrade AD. The Manual Diaphragm Release Technique improves diaphragmatic mobility, inspiratory capacity and exercise capacity in people with chronic obstructive pulmonary disease: a randomised trial. J Physiother. 2015 Oct;61(4):182-9. doi: 10.1016/j.jphys.2015.08.009. Epub 2015 Sep 19.
PubMed 26386894
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragm Release Manual Technique Efficacy on Diaphragmatic Mobility, Respiratory Muscle Strength and Exercise Performance in COPD Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02212184
- Acronym / sponsor ID
- Manual Therapy in COPD
- Conditions
- COPD
- Keywords
- Diaphragm, COPD, Musculoskeletal Manipulations, Ultrasonography, Optoelectronic Plethysmography.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Helga Cecília Muniz de SouzaUniversity, hospital or other
- Collaborators
- Universidade Federal de Pernambuco
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Aug 2014 (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 aims of this study are to evaluate the effects of Diaphragm Release Manual Technique on diaphragm mobility, chest wall kinematics and functional capacity of COPD patients. Methods: Randomized controlled trial (double blinded) with COPD patients, allocated in two group: intervention (IG) who will receive the Diaphragm Release manual technique on 6 non-consecutive sessions and control group (CG), who will receive a sham protocol (light touch) with the same parameters of IG. Outcomes will be evaluated as: immediate and post treatment effects (after 1 and 6 sessions respectively). The primary outcome analysed will be the diaphragm displacement (ultrasonography evaluation) and secondary outcomes will comprise abdominal and chest wall kinematics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Sham comparator | Other: Manual Diaphragm release technique (sham)Manual Diaphragm release technique (sham) In attempt to execute the sham protocol the therapist performs manual contact (pisiform, ulnar edge and the last three fingers) with the underside of the costal cartilage of the 7th, 8th, 9th and 10th rib. The therapist will hold only light touch in the landmarks, without exerting pressure or traction. The maneuver will be performed in two sets of ten deep breaths, with an one minute interval between them. |
| Intevention Group | Experimental | Other: Manual Diaphragm Release TechniqueAll patients will receive the Manual Diaphragm Release Technique, during 6 days of treatment. They will undertake four evaluations throughout treatment: before and immediately after the Day 1 (Baseline 1 and Post 1) and before and after Day 6 (Baseline 6 and Post 6). In the other Days (2nd to 5th) patients will only receive the intervention and won't be evaluated. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- CPOD patients
- ex-smokers
- clinically stable patients (no exacerbation in the previous 6 weeks)
- forced expiratory volume in one second (FEV1) < than 80% predicted
- FEV1/FVC ≤ 0.7, post bronchodilator
Key exclusion criteria (4 listed)
- cardiopulmonary diseases
- BMI > 30.0 kg/m2
- History of thoracic surgery
- Denial to participate
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 |
|---|---|---|
| Manual Diaphragm Release TechniqueAlso: Manual Diaphragm Stretching TechniqueThe therapist performs manual contact (pisiform, ulnar edge and the last three fingers) with the underside of the costal cartilage of the 7th, 8th, 9th and 10th rib, and guiding forearms toward the shoulders of the corresponding side. During inspiration, pulls the points of contact with both hands, in the direction of the head, accompanying the elevation movement of the ribs. During exhalation, deepens contact toward the inner costal, maintaining resistance. 2 sets x 10 breaths (1 min interval). Treatment will last two weeks (6 sessions) All patients will undertake four evaluations throughout treatment: Baseline Day 1 and post Day 1; Baseline Day 6 and post Day 6. | Other | Intevention Group |
| Manual Diaphragm release technique (sham)Manual Diaphragm release technique (sham) In attempt to execute the sham protocol the therapist performs manual contact (pisiform, ulnar edge and the last three fingers) with the underside of the costal cartilage of the 7th, 8th, 9th and 10th rib. The therapist will hold only light touch in the landmarks, without exerting pressure or traction. The maneuver will be performed in two sets of ten deep breaths, with an one minute interval between them. | Other | Control Group |
Primary outcome
Diaphragm mobility
Time frame: Diaphragm mobility at first session and after two weeks of treatment.
To evaluate diaphragmatic mobility a high-resolution ultrasound SonoaceR3 (Samsung Medison - South Korea) with a 3.5 MHz convex transducer will be used. Volunteers will remain in a supine position and receive verbal command to perform Inspiratory capacity maneuvers (IC), and the measurement of each curve referring to the diaphragmatic displacement (in mm) will be performed immediately after obtaining the images. The maneuvers will be repeated until obtaining 5 satisfactory images. The average of the three highest values not differing by more than 10% between their values should be accepted.
1 secondary outcome
Compartmental Chest wall volume
Time frame: Compartmental Chest wall volume evaluated by Opto-electronic Plethysmograph at the first session and after two weeks of treatment
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 2 Dec 2015.
- Derived from this study: PubMed 26386894Rocha T, Souza H, Brandao DC, Rattes C, Ribeiro L, Campos SL, Aliverti A, de Andrade AD. The Manual Diaphragm Release Technique improves diaphragmatic mobility, inspiratory capacity and exercise capacity in people with chronic obstructive pulmonary disease: a randomised trial. J Physiother. 2015 Oct;61(4):182-9. doi: 10.1016/j.jphys.2015.08.009. Epub 2015 Sep 19.
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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.
Armele D de Andrade, Post Doctor study director
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 Manual Diaphragm Release Technique in people with COPD, run by Helga Cecília Muniz de Souza 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 5 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 2 Dec 2015. 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. 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?
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?
Diaphragm mobility (time frame: Diaphragm mobility at first session and after two weeks of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02212184, which also lists 1 linked publication.
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 2 Dec 2015.