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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01953185
Other study ID # taciano01
Secondary ID
Status Completed
Phase N/A
First received September 25, 2013
Last updated September 27, 2013
Start date January 2011
Est. completion date December 2011

Study information

Verified date December 2012
Source Universidade Federal de Pernambuco
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial Summary

Question: Does manual diaphragm release change kinematics and respiratory function of elderly subjects? Design: Randomized controlled trial with concealed allocation and double-blinding.

Participants: 17 volunteers over 60 years old randomized into two groups: 09 in the Control Group (CG) and 08 in the Intervention Group (IG).

Intervention: The manual diaphragm release technique was used on the IG, in two sets of ten deep breaths, with a one minute interval between them. The CG underwent a sham protocol (light touch), with same sets and time of interval.

Outcome measures: The groups were evaluated using spirometry, manovacuometry and optoelectronic plethysmography (OEP), in that order, before and immediately after the intervention.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date December 2011
Est. primary completion date January 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 60 Years to 68 Years
Eligibility Inclusion Criteria:

- over 60 years of age;

- a body mass index (BMI) below 30 kg/m2

- non-smokers, self-declared sedentary;

- presenting a forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) greater than or equal to 80% of predicted;

- the ratio between these variables (FEV1/FVC) greater than 70% in spirometry

Exclusion Criteria:

- Showed the inability to understand verbal commands in the evaluation.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Sham manual diaphragm release technique
For this group, light touch at the same anatomical points was done without exerting pressure or traction. Positioning and duration were identical to the IG to perform the sham protocol (Licciardone & Russo, 2006).
The manual diaphragm release technique
To perform the technique the volunteer was placed in supine position with limbs relaxed. Positioned behind the head of the volunteer, the therapist performed 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. In the inspiratory phase, the therapist gently pulled the points of contact with both hands, in the direction of the head, yet slightly lateral, accompanying the elevation movement of the ribs. During exhalation, the therapist deepened contact toward the inner costal, maintaining resistance throughout the inspiratory phase. In the breaths following, the therapist sought to gain traction and smooth increase in the deepening of contacts. This maneuver was performed in two sets of ten deep breaths, with a one minute interval between them.

Locations

Country Name City State
Brazil Universidade Federal de Pernambuco Recife Pernambuco

Sponsors (1)

Lead Sponsor Collaborator
Daniella Cunha Brandao

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Aliverti A, Pedotti A. Opto-electronic plethysmography. Monaldi Arch Chest Dis. 2003 Jan-Mar;59(1):12-6. — View Citation

De Troyer A. Respiratory effect of the lower rib displacement produced by the diaphragm. J Appl Physiol (1985). 2012 Feb;112(4):529-34. doi: 10.1152/japplphysiol.01067.2011. Epub 2011 Dec 1. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Compartmental chest wall volume 1 day Yes
Secondary Pulmonary function 1 day Yes
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