Diaphragm Release Manual Technique Efficacy in COPD Patients

NCT02212184 | Completed DMC

• 1 other identifier: Manual Therapy in COPD
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

Diaphragm; COPD; Musculoskeletal Manipulations; Ultrasonography; Optoelectronic Plethysmography.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Compartmental Chest wall volume

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

Other Outcomes (2)

• Six-minute walking distance

  Six-minute walking distance (6MWD) evaluated by 6 minutes walking test at the first session and after two weeks of treatment

• Respiratory muscle strength

  Respiratory muscle strength measured by manovacuometry at the first session and after two weeks of treatment

Study Arms (2)

Control Group

SHAM COMPARATOR

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)

Intevention Group

EXPERIMENTAL

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

Interventions

Manual Diaphragm Release Technique OTHER

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.

Also known as: Manual Diaphragm Stretching Technique

Intevention Group

Manual Diaphragm release technique (sham) OTHER

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.

Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• cardiopulmonary diseases
• BMI \> 30.0 kg/m2
• History of thoracic surgery
• Denial to participate

Sponsors & Collaborators

• Helga Cecília Muniz de Souza: lead
• Universidade Federal de Pernambuco: collaborator

Study Sites (1)

UFPernambuco

Recife, Pernambuco, Brazil

Location

Related Publications (1)

• 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.

  PMID: 26386894 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Armele D de Andrade, Post Doctor

  Universidade Federal de Pernambuco

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MsC

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: August 8, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

BR (1)