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

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 Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Other: Manual Diaphragm release technique (sham); Other: Manual Diaphragm Release Technique

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil
      • UFPernambuco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control Group; 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: 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.
Experimental: Intevention Group; 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.	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.; Other Names: Manual Diaphragm Stretching Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Helga Cecília Muniz de Souza
• Collaborators: Universidade Federal de Pernambuco
• Investigators: Study Director: Armele D de Andrade, Post Doctor, Universidade Federal de Pernambuco

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 12, 2014
• First Submitted That Met QC Criteria: August 7, 2014
• First Posted (Estimate): August 8, 2014

Study Record Updates

• Last Update Posted (Estimate): December 2, 2015
• Last Update Submitted That Met QC Criteria: November 30, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: COPD; Ultrasonography; Diaphragm; Musculoskeletal Manipulations; Optoelectronic Plethysmography.
• Other Study ID Numbers: manual therapy in COPD