AsthmaNCT02047370
Manual Therapy in Patients With Asthma
A study testing Diaphragm stretching in people with Asthma, run by Universidad de Granada at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Asthma
- What is being tested?
- Diaphragm stretching
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ranging between 18 and 45 years.
- Diagnosis of asthma.
- No exacerbations during last month.
Who cannot join
- History of spine surgery.
- Diabetes, neurological or a cardiovascular disease.
- Spine deformities and use of orthopedic devices.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of health Sciences. University of Granada
Granada, Spain, 18071
About this study
Official title: Effects of Manual Therapy in Patients With Asthma
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Diaphragm stretching, Placebo
- Keywords
- stretching, diaphragm, asthma, manual therapy
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragm stretchingOther
Also called Manual therapy
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.
PlaceboOther
Also called Disconnected ultrasound.
The same therapist, patient position and duration of the technique, but using disconnected ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Diaphragm stretching | Experimental | 30 Patients with asthma are included in this group. They will receive a diaphragm stretching technique Receives: Other: Diaphragm stretching |
| Placebo group | Placebo comparator | Ultrasound disconnected in same position and with the same duration. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 7 days
Secondary outcomes (4)
Abdominal Kinematics
Abdominal kinematic measurements can be used as an evaluative method to quantify possible alterations in abdominal movements.
Measured: baseline, 7 days
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.
Measured: baseline, 7 days
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.
Measured: baseline, 7 days
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
Measured: baseline, 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: The sample size was not completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
- Investigators
- Marie Carmen Valenza, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047370
- Sponsor's protocol ID
- DF0046UG
- Status last verified
- Dec 2015
- First submitted
- 22 Jan 2014
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Manual Therapy in Patients With Asthma
- ClinicalTrials.gov ID
- NCT02047370
- Acronym / sponsor ID
- DF0046UG
- Conditions
- Asthma
- Keywords
- stretching, diaphragm, asthma, manual therapy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The sample size was not completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diaphragm stretching | Experimental | Other: Diaphragm stretching30 Patients with asthma are included in this group. They will receive a diaphragm stretching technique |
| Placebo group | Placebo comparator | Other: PlaceboUltrasound disconnected in same position and with the same duration. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age ranging between 18 and 45 years.
- Diagnosis of asthma.
- No exacerbations during last month.
Key exclusion criteria (3 listed)
- History of spine surgery.
- Diabetes, neurological or a cardiovascular disease.
- Spine deformities and use of orthopedic devices.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragm stretchingAlso: Manual therapyThe 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. | Other | Diaphragm stretching |
| PlaceboAlso: Disconnected ultrasound.The same therapist, patient position and duration of the technique, but using disconnected ultrasound | Other | Placebo group |
Primary outcome
Forced vital capacity
Time frame: Baseline, 7 days
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.
4 secondary outcomes
Abdominal Kinematics
Time frame: baseline, 7 days
Airway diffusing capacity
Time frame: baseline, 7 days
Forced expiratory volume in the first second
Time frame: baseline, 7 days
Rib cage excursion
Time frame: baseline, 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Carmen Valenza, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diaphragm stretching in people with Asthma, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 4 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced vital capacity (time frame: Baseline, 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2015; AzTrials last refreshed its copy on 4 Nov 2026.