NCT01953185

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2013

Completed
Last Updated

September 30, 2013

Status Verified

December 1, 2012

Enrollment Period

Same day

First QC Date

September 25, 2013

Last Update Submit

September 27, 2013

Conditions

Healthy

Keywords

elderlysubjects

Outcome Measures

Primary Outcomes (1)

  • Compartmental chest wall volume

    1 day

Secondary Outcomes (1)

  • Pulmonary function

    1 day

Study Arms (2)

Manual diaphragm release technique

EXPERIMENTAL
Other: The manual diaphragm release technique

Control group

SHAM COMPARATOR
Other: Sham manual diaphragm release technique

Interventions

Sham manual diaphragm release techniqueOTHER

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).

Control group
The manual diaphragm release techniqueOTHER

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

Age60 Years - 68 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Pernambuco

Recife, Pernambuco, 5000, Brazil

Location

Related Publications (2)

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

    PMID: 14533277RESULT

  • 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.

    PMID: 22134697RESULT

Study Officials

  • Taciano Rocha, Msc

    Universidade Federal de Pernambuco

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 25, 2013

First Posted

September 30, 2013

Study Start

January 1, 2011

Primary Completion

January 1, 2011

Study Completion

December 1, 2011

Last Updated

September 30, 2013

Record last verified: 2012-12

Locations

BR(1)