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Clinical Trials/NCT02212184
NCT02212184
Completed
Not Applicable

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

Helga Cecília Muniz de Souza1 site in 1 country26 target enrollmentAugust 2014
ConditionsCOPD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD
Sponsor
Helga Cecília Muniz de Souza
Enrollment
26
Locations
1
Primary Endpoint
Diaphragm mobility
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
December 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Helga Cecília Muniz de Souza
Responsible Party
Sponsor Investigator
Principal Investigator

Helga Cecília Muniz de Souza

MsC

Universidade Federal de Pernambuco

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

Outcomes

Primary Outcomes

Diaphragm mobility

Time Frame: 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 Outcomes

  • Compartmental Chest wall volume(Compartmental Chest wall volume evaluated by Opto-electronic Plethysmograph at the first session and after two weeks of treatment)

Study Sites (1)

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