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Diaphragm Release Manual Technique Efficacy in COPD Patients

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ClinicalTrials.gov Identifier: NCT02212184
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : December 2, 2015
Sponsor:
Collaborator:
Universidade Federal de Pernambuco
Information provided by (Responsible Party):
Helga Cecília Muniz de Souza, Universidade Federal de Pernambuco

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.

Condition or disease Intervention/treatment Phase
COPD Other: Manual Diaphragm Release Technique Other: Manual Diaphragm release technique (sham) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Diaphragm Release Manual Technique Efficacy on Diaphragmatic Mobility, Respiratory Muscle Strength and Exercise Performance in COPD Patients: a Randomized Controlled Trial
Study Start Date : August 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014

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 Name: Manual Diaphragm Stretching Technique




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Compartmental Chest wall volume [ Time Frame: 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.


Other Outcome Measures:
  1. Six-minute walking distance [ Time Frame: Six-minute walking distance (6MWD) evaluated by 6 minutes walking test at the first session and after two weeks of treatment ]
    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.

  2. Respiratory muscle strength [ Time Frame: Respiratory muscle strength measured by manovacuometry at the first session and after two weeks of treatment ]
    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.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212184


Locations
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Brazil
UFPernambuco
Recife, Pernambuco, Brazil
Sponsors and Collaborators
Helga Cecília Muniz de Souza
Universidade Federal de Pernambuco
Investigators
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Study Director: Armele D de Andrade, Post Doctor Universidade Federal de Pernambuco

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Helga Cecília Muniz de Souza, MsC, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT02212184     History of Changes
Other Study ID Numbers: Manual Therapy in COPD
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Keywords provided by Helga Cecília Muniz de Souza, Universidade Federal de Pernambuco:
Diaphragm
COPD
Musculoskeletal Manipulations
Ultrasonography
Optoelectronic Plethysmography.