- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01975740
Manual Diaphragm Release Technique Effects On Tidal Volume in Elderly
Manual Diaphragm Release Technique Effects On 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, 52011000
- Federal University of 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: SINGLE_GROUP
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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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Other: Sham manual diaphragm release technique
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
before first session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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Before first session
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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.
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Before first session
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Collaborators and Investigators
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
Terms related to this study
Other Study ID Numbers
- Diaphragm Manual Technique
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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