Diaphragm Release Manual Technique Efficacy in COPD Patients

Not Applicable

Completed

• Conditions: COPD
• Interventions: Other: Manual Diaphragm release technique (sham); Other: Manual Diaphragm Release Technique

• Registration Number: NCT02212184
• Lead Sponsor: Helga Cecília Muniz de Souza

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-12
• Study Start: 2014-08
• Study First Submitted QC: 2014-08-07
• Study First Posted: 2014-08-08
• Primary Completion: 2014-10
• Study Completion: 2014-12
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control 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.
Intevention Group	Manual Diaphragm Release Technique	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.

Primary Outcome Measures

Name	Time	Method
Diaphragm mobility	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.

Secondary Outcome Measures

Name	Time	Method
Compartmental Chest wall volume	Compartmental Chest wall volume evaluated by Opto-electronic Plethysmograph at the first session and after two weeks of treatment	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.

Trial Locations

Locations (1)

UFPernambuco; 🇧🇷 Recife, Pernambuco, Brazil