Manual Therapy in Patients With Asthma
Primary Purpose
Asthma
Status
Suspended
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Diaphragm stretching
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring stretching, diaphragm, asthma, manual therapy
Eligibility Criteria
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.
Sites / Locations
- Faculty of health Sciences. University of Granada
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Diaphragm stretching
Placebo group
Arm Description
30 Patients with asthma are included in this group. They will receive a diaphragm stretching technique
Ultrasound disconnected in same position and with the same duration.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Abdominal Kinematics
Abdominal kinematic measurements can be used as an evaluative method to quantify possible alterations in abdominal movements.
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.
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.
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
Full Information
NCT ID
NCT02047370
First Posted
January 22, 2014
Last Updated
December 3, 2015
Sponsor
Universidad de Granada
1. Study Identification
Unique Protocol Identification Number
NCT02047370
Brief Title
Manual Therapy in Patients With Asthma
Official Title
Effects of Manual Therapy in Patients With Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Suspended
Why Stopped
The sample size was not completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
stretching, diaphragm, asthma, manual therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diaphragm stretching
Arm Type
Experimental
Arm Description
30 Patients with asthma are included in this group. They will receive a diaphragm stretching technique
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Ultrasound disconnected in same position and with the same duration.
Intervention Type
Other
Intervention Name(s)
Diaphragm stretching
Other Intervention Name(s)
Manual therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Disconnected ultrasound.
Intervention Description
The same therapist, patient position and duration of the technique, but using disconnected ultrasound
Primary Outcome Measure Information:
Title
Forced vital capacity
Description
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.
Time Frame
Baseline, 7 days
Secondary Outcome Measure Information:
Title
Abdominal Kinematics
Description
Abdominal kinematic measurements can be used as an evaluative method to quantify possible alterations in abdominal movements.
Time Frame
baseline, 7 days
Title
Airway diffusing capacity
Description
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.
Time Frame
baseline, 7 days
Title
Forced expiratory volume in the first second
Description
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.
Time Frame
baseline, 7 days
Title
Rib cage excursion
Description
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
Time Frame
baseline, 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Carmen Valenza, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of health Sciences. University of Granada
City
Granada
ZIP/Postal Code
18071
Country
Spain
12. IPD Sharing Statement
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Manual Therapy in Patients With Asthma
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