HealthyNCT04737824
Immediate and Long-term Effects of an Adaptation of the "Balloon-blowing Exercise"
A study testing An adaptation of the "balloon-blowing" exercise and An adaptation of the "balloon-blowing" exercise for seven weeks, three times a week, at home in people with Healthy, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
Trial summary
Despite the literature evidence that the "balloon-blowing exercise" improves the pulmonary function as a long-term effect, this exercise has not yet been studied or tested experimentally, meaning that there are no specific and measurable results that attest the improvement on thoracoabdominal movement. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- An adaptation of the "balloon-blowing" exercise and An adaptation of the "balloon-blowing" exercise for seven weeks, three times a week, at home
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Feb 2021to 31 Mar 2021
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In the Experimental Group B were admitted individuals that, through the analysis of the training record sheet, had executed 2⁄3 of the programmed sessions.
Who cannot join
- Individuals that had participated in aerobic physical activities of moderate (i.e., at least 30 minutes on five days per week) or vigorous intensity (i.e., at least 20 minutes on three days per week) for more than one year;
- Chronic nonspecific lumbopelvic pain (i.e., recurrent episodes of lumbopelvic pain for a period exceeding three months);
- Flu symptoms or respiratory infection up to one week before data collection;
- History of recent ribs fracture and pain in the last three months;
- Pulmonary or rib cage previous pathologies;
- Length discrepancy of the lower limbs or other postural asymmetries;
Show all 9Show fewer
- History of spinal, gynaecological, or abdominal surgery in the previous year;
- Recurrent muscle/joint pain and history of musculoskeletal injury in the last three months;
- Smoking and/or drinking habits.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Escola Superior de Saúde - Instituto Politécnico do Porto
Porto, 4200-072
About this study
Official title: Immediate and Long-term Effects of an Adaptation of the "Balloon-blowing Exercise" on the Thoracoabdominal Movement in Healthy Students - a Randomized Controlled Trial
Despite the literature evidence that the "balloon-blowing exercise" improves the pulmonary function as a long-term effect, this exercise has not yet been studied or tested experimentally, meaning that there are no specific and measurable results that attest the improvement on thoracoabdominal movement.
- Conditions
- Healthy
- Being tested
- An adaptation of the "balloon-blowing" exercise, An adaptation of the "balloon-blowing" exercise for seven weeks, three times a week, at home
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An adaptation of the "balloon-blowing" exerciseProcedure or surgery
Also called Motor control exercise A
The participants were positioned in supine, on a semi-rigid surface, with the upper limbs placed above the level of the head, at rest. Their feet were also placed at a resting position on a wall and with their hips and knees at 90o of flexion. The cervical was placed in a neutral position and the pelvis was maintained in a posterior pelvic tilt, both structures corrected by the researcher. The participants were asked to contract the adductors, maintaining a bilateral and symmetric pressure between 10 and 15 mmHg on two sphygmomanometers placed between the knees. Also, an isometric contraction of the hamstrings and gluteus was requested. A Threshold®, with a minimum resistance of 5 cmH2O, and they were instructed to close their lips around the mouthpiece, to avoid air leaks. To start the exercise, it was transmitted to the participants to make a maximum inspiration through the nose, for two seconds. Subsequently, a maximum exhalation throughout the threshold was made for three seconds.
An adaptation of the "balloon-blowing" exercise for seven weeks, three times a week, at homeProcedure or surgery
Also called Motor control exercise B
The participants were positioned in supine, on a semi-rigid surface, with the upper limbs placed above the level of the head, at rest. Their feet were also placed at a resting position on a wall and with their hips and knees at 90o of flexion. The cervical was placed in a neutral position and the pelvis was maintained in a posterior pelvic tilt, both structures corrected by the researcher. The participants were asked to contract the adductors, maintaining a bilateral and symmetric pressure between 10 and 15 mmHg on two sphygmomanometers placed between the knees. Also, an isometric contraction of the hamstrings and gluteus was requested. A Threshold®, with a minimum resistance of 5 cmH2O, and they were instructed to close their lips around the mouthpiece, to avoid air leaks. To start the exercise, it was transmitted to the participants to make a maximum inspiration through the nose, for two seconds. Subsequently, a maximum exhalation throughout the threshold was made for three seconds.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group A | Experimental | Participants executed two sets of twelve repetitions of an adaptation of the "balloon-blowing" exercise. Receives: Procedure: An adaptation of the "balloon-blowing" exercise |
| Control group A | No intervention | No intervention was applied. |
| Experimental group B | Experimental | Participants executed two sets of twelve repetitions of an adaptation of the "balloon-blowing" exercise for seven weeks, three times a week, at home. Receives: Procedure: An adaptation of the "balloon-blowing" exercise for seven weeks, three times a week, at home |
| Control group B | No intervention | No intervention was applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior-to-posterior movement of the upper rib cage
Thoracoabdominal movement was measure through "Qualisys motion capture system".
Measured: Immediate after procedure
Anterior-to-posterior movement of the lower rib cage
Thoracoabdominal movement was measure through "Qualisys motion capture system".
Measured: Immediate after procedure
Anterior-to-posterior abdominal movement
Thoracoabdominal movement was measure through "Qualisys motion capture system".
Measured: Immediate after procedure
Medial-to-lateral movement of the upper rib cage
Thoracoabdominal movement was measure through "Qualisys motion capture system".
Measured: Immediate after procedure
Medial-to-lateral movement of the lower rib cage
Thoracoabdominal movement was measure through "Qualisys motion capture system".
Measured: Immediate after procedure
Anterior-to-posterior movement of the upper rib cage
Thoracoabdominal movement was measure through "Qualisys motion capture system".
Measured: Seven weeks
Anterior-to-posterior movement of the lower rib cage
Thoracoabdominal movement was measure through "Qualisys motion capture system".
Measured: Seven weeks
Anterior-to-posterior abdominal movement
Thoracoabdominal movement was measure through "Qualisys motion capture system".
Measured: Seven weeks
Medial-to-lateral movement of the upper rib cage
Thoracoabdominal movement was measure through "Qualisys motion capture system".
Measured: Seven weeks
Medial-to-lateral movement of the lower rib cage
Thoracoabdominal movement was measure through "Qualisys motion capture system".
Measured: Seven weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start1 Feb 2021
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, António Manuel Soares Mesquita Montes, Escola Superior de Tecnologia da Saúde do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737824
- Sponsor's protocol ID
- ESS-Balloon
- Status last verified
- Aug 2021
- First submitted
- 30 Jan 2021
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Boyle KL, Olinick J, Lewis C. The value of blowing up a balloon. N Am J Sports Phys Ther. 2010 Sep;5(3):179-88.
PubMed 21589673De Troyer A. Respiratory effect of the lower rib displacement produced by the diaphragm. J Appl Physiol (1985). 2012 Feb;112(4):529-34. doi: 10.1152/japplphysiol.01067.2011. Epub 2011 Dec 1.
PubMed 22134697Key J. 'The core': understanding it, and retraining its dysfunction. J Bodyw Mov Ther. 2013 Oct;17(4):541-59. doi: 10.1016/j.jbmt.2013.03.012. Epub 2013 Jun 28.
PubMed 24139017
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate and Long-term Effects of an Adaptation of the "Balloon-blowing Exercise" on the Thoracoabdominal Movement in Healthy Students - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04737824
- Acronym / sponsor ID
- ESS-Balloon
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do PortoUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 4 Feb 2021 (actual)
- 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.
Despite the literature evidence that the "balloon-blowing exercise" improves the pulmonary function as a long-term effect, this exercise has not yet been studied or tested experimentally, meaning that there are no specific and measurable results that attest the improvement on thoracoabdominal movement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental group A | Experimental | Procedure: An adaptation of the "balloon-blowing" exerciseParticipants executed two sets of twelve repetitions of an adaptation of the "balloon-blowing" exercise. |
| Control group A | No intervention | –No intervention was applied. |
| Experimental group B | Experimental | Procedure: An adaptation of the "balloon-blowing" exercise for seven weeks, three times a week, at homeParticipants executed two sets of twelve repetitions of an adaptation of the "balloon-blowing" exercise for seven weeks, three times a week, at home. |
| Control group B | No intervention | –No intervention was applied. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- In the Experimental Group B were admitted individuals that, through the analysis of the training record sheet, had executed 2⁄3 of the programmed sessions.
Key exclusion criteria (9 listed)
- Individuals that had participated in aerobic physical activities of moderate (i.e., at least 30 minutes on five days per week) or vigorous intensity (i.e., at least 20 minutes on three days per week) for more than one year;
- Chronic nonspecific lumbopelvic pain (i.e., recurrent episodes of lumbopelvic pain for a period exceeding three months);
- Flu symptoms or respiratory infection up to one week before data collection;
- History of recent ribs fracture and pain in the last three months;
- Pulmonary or rib cage previous pathologies;
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 |
|---|---|---|
| An adaptation of the "balloon-blowing" exerciseAlso: Motor control exercise AThe participants were positioned in supine, on a semi-rigid surface, with the upper limbs placed above the level of the head, at rest. Their feet were also placed at a resting position on a wall and with their hips and knees at 90o of flexion. The cervical was placed in a neutral position and the pelvis was maintained in a posterior pelvic tilt, both structures corrected by the researcher. The participants were asked to contract the adductors, maintaining a bilateral and symmetric pressure between 10 and 15 mmHg on two sphygmomanometers placed between the knees. Also, an isometric contraction of the hamstrings and gluteus was requested. A Threshold®, with a minimum resistance of 5 cmH2O, and they were instructed to close their lips around the mouthpiece, to avoid air leaks. To start the exercise, it was transmitted to the participants to make a maximum inspiration through the nose, for two seconds. Subsequently, a maximum exhalation throughout the threshold was made for three seconds. | Procedure or surgery | Experimental group A |
| An adaptation of the "balloon-blowing" exercise for seven weeks, three times a week, at homeAlso: Motor control exercise BThe participants were positioned in supine, on a semi-rigid surface, with the upper limbs placed above the level of the head, at rest. Their feet were also placed at a resting position on a wall and with their hips and knees at 90o of flexion. The cervical was placed in a neutral position and the pelvis was maintained in a posterior pelvic tilt, both structures corrected by the researcher. The participants were asked to contract the adductors, maintaining a bilateral and symmetric pressure between 10 and 15 mmHg on two sphygmomanometers placed between the knees. Also, an isometric contraction of the hamstrings and gluteus was requested. A Threshold®, with a minimum resistance of 5 cmH2O, and they were instructed to close their lips around the mouthpiece, to avoid air leaks. To start the exercise, it was transmitted to the participants to make a maximum inspiration through the nose, for two seconds. Subsequently, a maximum exhalation throughout the threshold was made for three seconds. | Procedure or surgery | Experimental group B |
Primary outcome
Anterior-to-posterior movement of the upper rib cage
Time frame: Immediate after procedure
Thoracoabdominal movement was measure through "Qualisys motion capture system".
Anterior-to-posterior movement of the lower rib cage
Time frame: Immediate after procedure
Thoracoabdominal movement was measure through "Qualisys motion capture system".
Anterior-to-posterior abdominal movement
Time frame: Immediate after procedure
Thoracoabdominal movement was measure through "Qualisys motion capture system".
Medial-to-lateral movement of the upper rib cage
Time frame: Immediate after procedure
Thoracoabdominal movement was measure through "Qualisys motion capture system".
Medial-to-lateral movement of the lower rib cage
Time frame: Immediate after procedure
Thoracoabdominal movement was measure through "Qualisys motion capture system".
Anterior-to-posterior movement of the upper rib cage
Time frame: Seven weeks
Thoracoabdominal movement was measure through "Qualisys motion capture system".
Anterior-to-posterior movement of the lower rib cage
Time frame: Seven weeks
Thoracoabdominal movement was measure through "Qualisys motion capture system".
Anterior-to-posterior abdominal movement
Time frame: Seven weeks
Thoracoabdominal movement was measure through "Qualisys motion capture system".
Medial-to-lateral movement of the upper rib cage
Time frame: Seven weeks
Thoracoabdominal movement was measure through "Qualisys motion capture system".
Medial-to-lateral movement of the lower rib cage
Time frame: Seven weeks
Thoracoabdominal movement was measure through "Qualisys motion capture system".
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 31 Aug 2021.
- Background: PubMed 21589673Boyle KL, Olinick J, Lewis C. The value of blowing up a balloon. N Am J Sports Phys Ther. 2010 Sep;5(3):179-88.
- Background: PubMed 22134697De Troyer A. Respiratory effect of the lower rib displacement produced by the diaphragm. J Appl Physiol (1985). 2012 Feb;112(4):529-34. doi: 10.1152/japplphysiol.01067.2011. Epub 2011 Dec 1.
- Background: PubMed 24139017Key J. 'The core': understanding it, and retraining its dysfunction. J Bodyw Mov Ther. 2013 Oct;17(4):541-59. doi: 10.1016/j.jbmt.2013.03.012. Epub 2013 Jun 28.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An adaptation of the "balloon-blowing" exercise and An adaptation of the "balloon-blowing" exercise for seven weeks, three times a week, at home in people with Healthy, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
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 1 inclusion and 9 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 31 Aug 2021. 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 Portugal. 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.
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?
Anterior-to-posterior movement of the upper rib cage (time frame: Immediate after procedure). The study lists 10 primary outcomes in all. 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 NCT04737824, which also lists 3 linked publications.
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 31 Aug 2021.