Manual Diaphragm Release Technique Effects On Tidal Volume in Elderly

NCT01975740 | Completed DMC

• 1 other identifier: Diaphragm Manual Technique
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Maximal inspiratory and expiratory pressures

  Before first session

• Pulmonary Function

  Before first session

Study Arms (2)

Manual diaphragm release technique

EXPERIMENTAL

Other: The manual diaphragm release technique

Sham manual diaphragm release technique

OTHER

Other: Sham manual diaphragm release technique

Interventions

Sham manual diaphragm release technique OTHER

Sham manual diaphragm release technique

The manual diaphragm release technique OTHER

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.

Manual diaphragm release technique

Eligibility Criteria

• Age: 60 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Federal University of Pernambuco

Recife, Pernambuco, 52011000, Brazil

Location

Study Design

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

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 5, 2013
• Study Start: January 1, 2013
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: November 5, 2013

Record last verified: 2013-10

Locations

BR (1)