Manual Diaphragm Release Technique Effects On Tidal Volume in Elderly

Healthy Clinical Trial

Official title:

Manual Diaphragm Release Technique Effects On Tidal Volume And Upper Rib Cage Contribution During Quiet Breathing In Elderly: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01975740
• Other study ID #: Diaphragm Manual Technique
• Status: Completed
• Phase: N/A
• First received: October 29, 2013
• Last updated: November 4, 2013
• Start date: January 2013
• Est. completion date: February 2013

Study information

• Verified date: October 2013
• 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: 18
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• 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, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Sham manual diaphragm release technique

• 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	Federal University of Pernambuco	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compartmental chest wall distribution	The analysis of the regional distribution of respiratory volumes was done with Optoelectronic plethysmography (BTS Bioengineering, Italy), in which 89 reflective markers were adhered to the skin of volunteers using hypoallergenic adhesives, on particular anatomical points of the chest wall and abdomen (Aliverti and Pedotti 2003). The device emitted an infrared light on the reflective markers which was captured by eight cameras around the room, allowing the spatial determination of each marker. Thus, changes in lung volumes were calculated at each of the three compartments of the rib cage: pulmonary or upper ribcage (Rc, p), abdominal or lower ribcage (Rc, a) and abdomen (Ab). After the first OEP evaluation, a nontoxic, hypoallergenic pen was used to mark the placement of the dorsal reflective markers allowing the patient to lay in supine for the manual technique or the sham. The markers were then placed at the exact same anatomical points for reevaluation.	before first session	Yes
Secondary	Maximal inspiratory and expiratory pressures	The maximal inspiratory and expiratory pressures (MIP, MEP) were obtained from the residual volume and total lung capacity, respectively, according to the criteria of the ATS/ERS (ATS/ERS, 2002) and measured using a portable digital manometer, model MVD 300 (® MDI Ltd., Brazil).	Before first session	Yes
Secondary	Pulmonary Function	To assess the participant's lung function, a portable Micro Loop 8 (Micromedical, England) spirometer was used to evaluate the forced maneuver (Miller et al 2005). The study followed the criteria of acceptability in accordance with the ATS/ERS (2005). Values of FEV1, forced vital capacity (FVC), peak expiratory flow (PEF) and FEV1/FVC were obtained.	Before first session	Yes