Skip to main content
OpenTrials
Completed

NCT Number: NCT01975740

Manual Diaphragm Release Technique Effects On Tidal Volume in Elderly

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

60 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Pernambuco

Recife, Pernambuco, 52011000, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sham manual diaphragm release technique

Other

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.

Primary outcomes

  1. Compartmental chest wall distribution

    Time frame: before first session

    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.

Secondary outcomes

  1. Maximal inspiratory and expiratory pressures

    Time frame: Before first session

    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).

  2. Pulmonary Function

    Time frame: Before first session

    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.

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 5, 2013
Registry last updated
Nov 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.