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Diaphragm Release Manual Technique Efficacy in COPD Patients

Diaphragm Release Manual Technique Efficacy on Diaphragmatic Mobility, Respiratory Muscle Strength and Exercise Performance in COPD Patients: a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02212184
Enrollment
26
Registered
2014-08-08
Start date
2014-08-31
Completion date
2014-12-31
Last updated
2015-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

Diaphragm, COPD, Musculoskeletal Manipulations, Ultrasonography, Optoelectronic Plethysmography.

Brief 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 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.

Interventions

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.

OTHERManual 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.

Sponsors

Universidade Federal de Pernambuco
CollaboratorOTHER
Helga Cecília Muniz de Souza
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* cardiopulmonary diseases * BMI \> 30.0 kg/m2 * History of thoracic surgery * Denial to participate

Design outcomes

Primary

MeasureTime frameDescription
Diaphragm mobilityDiaphragm 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.

Secondary

MeasureTime frameDescription
Compartmental Chest wall volumeCompartmental Chest wall volume evaluated by Opto-electronic Plethysmograph at the first session and after two weeks of treatmentCompartmental 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.

Other

MeasureTime frameDescription
Six-minute walking distanceSix-minute walking distance (6MWD) evaluated by 6 minutes walking test at the first session and after two weeks of treatmentSix-minute walking tests (6MWT) will be performed in accordance to the ATS/ERS criteria, in the moments: Pre 1st session and Pre 6th session.
Respiratory muscle strengthRespiratory muscle strength measured by manovacuometry at the first session and after two weeks of treatmentMaximum inspiratory and expiratory pressures (MIP, MEP) will be obtained from the residual volume and total lung capacity, respectively, according to ATS/ERS criteria using a portable digital manometer, model MVD 300 (® MDI Ltda, Brazil). With the same instrument, the patient's nasal inspiratory pressure (SNIP) will also be assessed by placing the nasal plug into one nostril, without contralateral occlusion. Ten Sniff maneuvers should be performed with maximal inspiratory effort (60 seconds between each) and the greatest value achieved will be considered.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026