- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01953185
MANUAL DIAPHRAGM RELEASE TECHNIQUE INCREASES TIDAL VOLUME IN ELDERLY
MANUAL DIAPHRAGM RELEASE TECHNIQUE INCREASES TIDAL VOLUME AND UPPER RIB CAGE CONTRIBUTION DURING QUIET BREATHING IN ELDERLY: A RANDOMIZED CONTROLLED TRIAL
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pernambuco
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Recife, Pernambuco, Brazil, 5000
- Universidade Federal de Pernambuco
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Control group
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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).
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Experimental: Manual diaphragm release technique
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Compartmental chest wall volume
Time Frame: 1 day
|
1 day
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pulmonary function
Time Frame: 1 day
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1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Taciano Rocha, Msc, Universidade Federal de Pernambuco
Publications and helpful links
General Publications
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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