Diaphragm MobilityPhase 1NCT00997737
Diaphragm Activity During Incentive Spirometry and Diaphragmatic Breathing
A Phase 1 study testing DB, VI and FI in people with Diaphragm Mobility and Breathing Exercises, run by Hospital Sirio-Libanes at 1 site in Brazil.
Trial summary
The objective of the present study is to evaluate diaphragm activity during three breathing exercises: diaphragmatic breathing (DB), flow-oriented (Triflo II)incentive spirometry and volume-oriented (Voldyne) incentive spirometry. Seventeen healthy subjects will be studied (8 man and 9 woman). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Diaphragm Mobility, Breathing Exercises, Incentive Spirometry
- What is being tested?
- DB, VI and FI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2009to May 2010
- Phase
- Phase 1
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being 18 to 40 years old
- Having a normal body mass index
- Being a non-smoker
- Not knowing the DB and the IS techniques
- Reporting the absence of respiratory diseases.
Who cannot join
- Presenting alteration in respiratory function detected by functional analysis of lung volume and capacity
- Inability to understand or perform the procedure.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Ensino e Pesquisa do Hospital Sírio Libanês
São Paulo, São Paulo, 01308-050
About this study
Official title: Diaphragm Mobility During Respiratory Exercises With Incentive Spirometry in Healthy Individuals
The objective of the present study is to evaluate diaphragm activity during three breathing exercises: diaphragmatic breathing (DB), flow-oriented (Triflo II)incentive spirometry and volume-oriented (Voldyne) incentive spirometry.
Seventeen healthy subjects will be studied (8 man and 9 woman).
Read the detailed description
Right diaphragmatic mobility will be evaluated by determining the craniocaudal displacement of the left branch of the portal vein using a B-mode ultrasound device (Logic 500, Pro Series®; General ElectricMedical Systems, Milwaukee, WI, USA). The ultrasound technician will use a 3.5 MHz convex transducer positioned in the right subcostal region, with the incidence angle perpendicular to the craniocaudal axis, in the direction of the inferior vena cava. Next, an intraparenchymal portal branch will be identified in the field of vision and its position will be traced with the curser during the forced inspiration and expiration. The craniocaudal displacement of these points will be considered to be the amount of right diaphragmatic mobility.
- Being tested
- DB, VI and FI
- Keywords
- incentive spirometry, diaphragm mobility, ultrasound, diaphragmatic breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DB, VI and FIDevice
Also called diaphragmatic exercice, incentive spirometry
Two modalities of respiratory exercises based on deep and slow inspirations will be used: DB and IS. During DB, the researcher will place one hand slightly below the lower ribs in the abdominal region of the subject and the subject will be instructed to perform inspirations up to the maximum level of volume avoiding rib cage displacement; this recommendation will also be valid for exercises using incentive spirometers. IS will be executed using two different devices: Triflo II and Voldyne.
| Study group | Role | What they receive |
|---|---|---|
| DB, VI and FV | Experimental | Breathing exercises Receives: Device: DB, VI and FI |
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasound evaluation of the diaphragm mobility
Measured: six - eight months
Secondary outcomes (1)
pulmonary function test
Measured: six - eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diaphragm MobilityStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Investigators
- Wellington P Yamaguti, Master, Principal investigator, Hospital Sirio-Libanes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997737
- Sponsor's protocol ID
- HSL2008/26
- Status last verified
- Oct 2009
- First submitted
- 15 Oct 2009
- Last updated
- 28 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yamaguti WP, Sakamoto ET, Panazzolo D, Peixoto Cda C, Cerri GG, Albuquerque AL. Diaphragmatic mobility in healthy subjects during incentive spirometry with a flow-oriented device and with a volume-oriented device. J Bras Pneumol. 2010 Nov-Dec;36(6):738-45. doi: 10.1590/s1806-37132010000600011. English, Portuguese.
PubMed 21225177
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diaphragm Mobility During Respiratory Exercises With Incentive Spirometry in Healthy Individuals
- ClinicalTrials.gov ID
- NCT00997737
- Acronym / sponsor ID
- HSL2008/26
- Keywords
- incentive spirometry, diaphragm mobility, ultrasound, diaphragmatic breathing
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 19 Oct 2009 (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.
The objective of the present study is to evaluate diaphragm activity during three breathing exercises: diaphragmatic breathing (DB), flow-oriented (Triflo II)incentive spirometry and volume-oriented (Voldyne) incentive spirometry.
Seventeen healthy subjects will be studied (8 man and 9 woman).
Detailed description
Right diaphragmatic mobility will be evaluated by determining the craniocaudal displacement of the left branch of the portal vein using a B-mode ultrasound device (Logic 500, Pro Series®; General ElectricMedical Systems, Milwaukee, WI, USA). The ultrasound technician will use a 3.5 MHz convex transducer positioned in the right subcostal region, with the incidence angle perpendicular to the craniocaudal axis, in the direction of the inferior vena cava. Next, an intraparenchymal portal branch will be identified in the field of vision and its position will be traced with the curser during the forced inspiration and expiration. The craniocaudal displacement of these points will be considered to be the amount of right diaphragmatic mobility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DB, VI and FV | Experimental | Device: DB, VI and FIBreathing exercises |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Being 18 to 40 years old
- Having a normal body mass index
- Being a non-smoker
- Not knowing the DB and the IS techniques
- Reporting the absence of respiratory diseases.
Key exclusion criteria (2 listed)
- Presenting alteration in respiratory function detected by functional analysis of lung volume and capacity
- Inability to understand or perform the procedure.
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 |
|---|---|---|
| DB, VI and FIAlso: diaphragmatic exercice, incentive spirometryTwo modalities of respiratory exercises based on deep and slow inspirations will be used: DB and IS. During DB, the researcher will place one hand slightly below the lower ribs in the abdominal region of the subject and the subject will be instructed to perform inspirations up to the maximum level of volume avoiding rib cage displacement; this recommendation will also be valid for exercises using incentive spirometers. IS will be executed using two different devices: Triflo II and Voldyne. | Device | DB, VI and FV |
Primary outcome
ultrasound evaluation of the diaphragm mobility
Time frame: six - eight months
1 secondary outcome
pulmonary function test
Time frame: six - eight months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2010.
- Derived from this study: PubMed 21225177Yamaguti WP, Sakamoto ET, Panazzolo D, Peixoto Cda C, Cerri GG, Albuquerque AL. Diaphragmatic mobility in healthy subjects during incentive spirometry with a flow-oriented device and with a volume-oriented device. J Bras Pneumol. 2010 Nov-Dec;36(6):738-45. doi: 10.1590/s1806-37132010000600011. English, Portuguese.
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Healthy Volunteers
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.
Wellington P Yamaguti, Master principal investigator
Hospital Sirio-Libanes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DB, VI and FI in people with Diaphragm Mobility and Breathing Exercises, run by Hospital Sirio-Libanes at 1 site in Brazil.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 28 May 2010. 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 Brazil. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ultrasound evaluation of the diaphragm mobility (time frame: six - eight months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00997737, which also lists 1 linked publication.
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 28 May 2010.