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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT02047370
Other study ID # DF0046UG
Secondary ID
Status Suspended
Phase N/A
First received January 22, 2014
Last updated December 3, 2015
Start date January 2014
Est. completion date December 2016

Study information

Verified date December 2015
Source Universidad de Granada
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial Summary

Physical therapists have traditionally included various forms of manual therapy among the therapeutic approaches to respiratory conditions. The aim of this study was to evaluate the effect of diaphragmatic stretching technique on pulmonary ventilation, rig bage excursion and spirometric values in patients diagnosed with asthma.


Description:

Asthma is a chronic lung disease involving an inflammation and a narrowing of the airways. Asthma causes wheezing, chest tightness, shortness of breath, and coughing.

A variety of manual therapies are commonly used to treat patients with asthma. There is a need to conduct studies in order to examine the effects of manual therapies on clinically relevant outcomes. Techniques aim to increase movement in the rib cage and the spine to try and improve the working of the lungs and circulation.


Recruitment information / eligibility

Status Suspended
Enrollment 60
Est. completion date December 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Age ranging between 18 and 45 years.

- Diagnosis of asthma.

- No exacerbations during last month.

Exclusion Criteria:

- History of spine surgery.

- Diabetes, neurological or a cardiovascular disease.

- Spine deformities and use of orthopedic devices.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Diaphragm stretching
The therapist stands behind the patient and passes his hands around the thoracic cage, carefully introducing fingers under the costal margins. The patient slightly rounds the trunk in order to relax rectus abdominis. During the exhalation of the patient the therapist grasps the lower ribs and costal margin and eases the hands caudally. This traction was maintained during 5-7 minutes.
Placebo
The same therapist, patient position and duration of the technique, but using disconnected ultrasound

Locations

Country Name City State
Spain Faculty of health Sciences. University of Granada Granada

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Forced vital capacity The amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. It is going to be measured using a spirometer as recommended by the American Thoracic Society. Baseline, 7 days Yes
Secondary Abdominal Kinematics Abdominal kinematic measurements can be used as an evaluative method to quantify possible alterations in abdominal movements. baseline, 7 days Yes
Secondary Airway diffusing capacity The airway diffusion capacity will be measure using the deep breeze device. This is a non-invasive and radiation-free gadget that provides a dynamic image of the lungs, delivering both structural and functional information. baseline, 7 days Yes
Secondary Forced expiratory volume in the first second This is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. It is going to be measured using a spirometer as recommended by the American Thoracic Society. baseline, 7 days Yes
Secondary Rib cage excursion Rib cage excursion can be used as an evaluative method for diaphragmatic breathing excursion to quantify possible alterations in thoracic capacity and chest wall compliance as achieved by all expiratory and inspiratory muscles baseline, 7 days Yes
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