Clinical trial NCT02212184: Diaphragm Release Manual Technique Efficacy in COPD Patients
Official title: Diaphragm Release Manual Technique Efficacy on Diaphragmatic Mobility, Respiratory Muscle Strength and Exercise Performance in COPD Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Diaphragm
COPD
Musculoskeletal Manipulations
Ultrasonography
Optoelectronic Plethysmography.
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
Collaborators: name: Universidade Federal de Pernambuco
First posted: 2014-08-08
Enrollment: 26
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Diaphragm mobility
timeFrame: Diaphragm mobility at first session and after two weeks of treatment.
Secondary outcomes:
measure: Compartmental Chest wall volume
timeFrame: Compartmental Chest wall volume evaluated by Opto-electronic Plethysmograph at the first session and after two weeks of treatment
Other outcomes:
measure: Six-minute walking distance
timeFrame: Six-minute walking distance (6MWD) evaluated by 6 minutes walking test at the first session and after two weeks of treatment
measure: Respiratory muscle strength
timeFrame: Respiratory muscle strength measured by manovacuometry at the first session and after two weeks of treatment
Locations:
city: Recife
country: Brazil
facility: UFPernambuco
state: Pernambuco
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Armele D de Andrade, Post Doctor
role: STUDY_DIRECTOR
References:
citation: 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.