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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Portugal
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group A
Participants executed two sets of twelve repetitions of an adaptation of the "balloon-blowing" exercise.
Procedure: 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:
  • Motor control exercise A
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.
Procedure: 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:
  • Motor control exercise B
No Intervention: Control group B
No intervention was applied.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Escola Superior de Tecnologia da Saúde do Porto

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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