- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04737824
Immediate and Long-term Effects of an Adaptation of the "Balloon-blowing Exercise"
August 30, 2021 updated by: António Manuel Soares Mesquita Montes, Escola Superior de Tecnologia da Saúde do Porto
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Porto, Portugal, 4200-072
- Escola Superior de Saúde - Instituto Politécnico do Porto
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
The target population consisted of healthy physiotherapy students from School of Health - Polytechnic of Porto, who volunteered to participate in study.
Inclusion criteria:
- 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.
Exclusion criteria:
- 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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group A
Participants executed two sets of twelve repetitions of an adaptation of the "balloon-blowing" exercise.
|
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.
Other Names:
|
|
No Intervention: Control group A
No intervention was applied.
|
|
|
Experimental: Experimental group B
Participants executed two sets of twelve repetitions of an adaptation of the "balloon-blowing" exercise for seven weeks, three times a week, at home.
|
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.
Other Names:
|
|
No Intervention: Control group B
No intervention was applied.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anterior-to-posterior movement of the upper rib cage
Time Frame: Immediate after procedure
|
Thoracoabdominal movement was measure through "Qualisys motion capture system".
|
Immediate after procedure
|
|
Anterior-to-posterior movement of the lower rib cage
Time Frame: Immediate after procedure
|
Thoracoabdominal movement was measure through "Qualisys motion capture system".
|
Immediate after procedure
|
|
Anterior-to-posterior abdominal movement
Time Frame: Immediate after procedure
|
Thoracoabdominal movement was measure through "Qualisys motion capture system".
|
Immediate after procedure
|
|
Medial-to-lateral movement of the upper rib cage
Time Frame: Immediate after procedure
|
Thoracoabdominal movement was measure through "Qualisys motion capture system".
|
Immediate after procedure
|
|
Medial-to-lateral movement of the lower rib cage
Time Frame: Immediate after procedure
|
Thoracoabdominal movement was measure through "Qualisys motion capture system".
|
Immediate after procedure
|
|
Anterior-to-posterior movement of the upper rib cage
Time Frame: Seven weeks
|
Thoracoabdominal movement was measure through "Qualisys motion capture system".
|
Seven weeks
|
|
Anterior-to-posterior movement of the lower rib cage
Time Frame: Seven weeks
|
Thoracoabdominal movement was measure through "Qualisys motion capture system".
|
Seven weeks
|
|
Anterior-to-posterior abdominal movement
Time Frame: Seven weeks
|
Thoracoabdominal movement was measure through "Qualisys motion capture system".
|
Seven weeks
|
|
Medial-to-lateral movement of the upper rib cage
Time Frame: Seven weeks
|
Thoracoabdominal movement was measure through "Qualisys motion capture system".
|
Seven weeks
|
|
Medial-to-lateral movement of the lower rib cage
Time Frame: Seven weeks
|
Thoracoabdominal movement was measure through "Qualisys motion capture system".
|
Seven weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Key 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.
- 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.
- De 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2021
Primary Completion (Actual)
March 31, 2021
Study Completion (Actual)
March 31, 2021
Study Registration Dates
First Submitted
January 30, 2021
First Submitted That Met QC Criteria
January 30, 2021
First Posted (Actual)
February 4, 2021
Study Record Updates
Last Update Posted (Actual)
August 31, 2021
Last Update Submitted That Met QC Criteria
August 30, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- ESS-Balloon
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
University of Vermont Medical CenterAvocado Nutrition CenterRecruitingHealthy | Healthy Volunteers | Healthy Subjects | Healthy Volunteer | Healthy Adult | Healthy Volunteers Only | Healthy Male and Female Subjects | Healthy Non-smokersUnited States
-
Dragonfly TherapeuticsRecruitingHealthy | Healthy Participants | Healthy Adult Females | Volunteer | Healthy Adult MaleAustralia
-
University of PalermoCompletedHealthy | Healthy Volunteers | Healthy Subjects | Healthy Participants | Static Stretching | Stretch | StretchingItaly
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Umm Al-Qura UniversityActive, not recruitingHealthy | Healthy Participants | Healthy Adult | Healthy Women | Healthy Adult Females | Healthy Adult Participants | Healthy Young Adults | Healthy Adult Female Participants | Healthy Adult Male | Poor Sleep Quality | Healthy (Controls) | Poor Sleeping Quality | Healthy Adult Male Subjects | Health Adult SubjectsSaudi Arabia
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
University of PalermoCompletedHealthy Participants | Healthy Adult Participants | Healthy Young AdultsItaly
-
University Hospital, Strasbourg, FranceICube LaboratoryNot yet recruitingHealthy | Healthy AdultFrance
-
Beijing Tide Pharmaceutical Co., LtdRecruitingHealthy | Healthy ParticipantsChina
Clinical Trials on An adaptation of the "balloon-blowing" exercise
-
Chulalongkorn UniversityCompleted
-
Florida International UniversityRecruitingHIV Infection PrimaryUnited States
-
Foundation University IslamabadRecruiting
-
National Taiwan University HospitalNational Taiwan Normal UniversityCompletedElderly | Exercise TrainingTaiwan
-
Hospices Civils de LyonCompleted
-
Hospital Galdakao-UsansoloCarlos III Health InstituteCompleted
-
University of Illinois at ChicagoRecruitingDepression | Fatigue | Chronic Pain | Acute PainUnited States
-
Universitaire Ziekenhuizen KU LeuvenCompletedPulmonary Vascular DiseaseBelgium
-
State University of New York - Downstate Medical...National Institute of Mental Health (NIMH); Yale UniversityEnrolling by invitationHIV I InfectionUnited States
-
Akdeniz UniversityCompletedSleep Deprivation | Healthy Lifestyle | Psychosocial AdjustmentTurkey (Türkiye)