Diaphragm Release Manual Technique Efficacy in COPD Patients

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02212184
• Other study ID #: Manual Therapy in COPD
• Status: Completed
• Phase: N/A
• First received: June 12, 2014
• Last updated: November 30, 2015
• Start date: August 2014
• Est. completion date: December 2014

Study information

• Verified date: November 2015
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD

Intervention

Other:
• Manual Diaphragm Release 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)
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.

Locations

Country	Name	City	State
Brazil	UFPernambuco	Recife	Pernambuco

Sponsors (2)

Lead Sponsor	Collaborator
Helga Cecília Muniz de Souza	Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Six-minute walking distance	Six-minute walking tests (6MWT) will be performed in accordance to the ATS/ERS criteria, in the moments: Pre 1st session and Pre 6th session.	Six-minute walking distance (6MWD) evaluated by 6 minutes walking test at the first session and after two weeks of treatment	No
Other	Respiratory muscle strength	Maximum 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.	Respiratory muscle strength measured by manovacuometry at the first session and after two weeks of treatment	No
Primary	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.	Diaphragm mobility at first session and after two weeks of treatment.	No
Secondary	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.	Compartmental Chest wall volume evaluated by Opto-electronic Plethysmograph at the first session and after two weeks of treatment	No