NCT04737824

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

2 months

First QC Date

January 30, 2021

Last Update Submit

August 30, 2021

Conditions

Outcome Measures

Primary Outcomes (10)

  • Anterior-to-posterior movement of the upper rib cage

    Thoracoabdominal movement was measure through "Qualisys motion capture system".

    Immediate after procedure

  • Anterior-to-posterior movement of the lower rib cage

    Thoracoabdominal movement was measure through "Qualisys motion capture system".

    Immediate after procedure

  • Anterior-to-posterior abdominal movement

    Thoracoabdominal movement was measure through "Qualisys motion capture system".

    Immediate after procedure

  • Medial-to-lateral movement of the upper rib cage

    Thoracoabdominal movement was measure through "Qualisys motion capture system".

    Immediate after procedure

  • Medial-to-lateral movement of the lower rib cage

    Thoracoabdominal movement was measure through "Qualisys motion capture system".

    Immediate after procedure

  • Anterior-to-posterior movement of the upper rib cage

    Thoracoabdominal movement was measure through "Qualisys motion capture system".

    Seven weeks

  • Anterior-to-posterior movement of the lower rib cage

    Thoracoabdominal movement was measure through "Qualisys motion capture system".

    Seven weeks

  • Anterior-to-posterior abdominal movement

    Thoracoabdominal movement was measure through "Qualisys motion capture system".

    Seven weeks

  • Medial-to-lateral movement of the upper rib cage

    Thoracoabdominal movement was measure through "Qualisys motion capture system".

    Seven weeks

  • Medial-to-lateral movement of the lower rib cage

    Thoracoabdominal movement was measure through "Qualisys motion capture system".

    Seven weeks

Study Arms (4)

Experimental group A

EXPERIMENTAL

Participants executed two sets of twelve repetitions of an adaptation of the "balloon-blowing" exercise.

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.

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.

Interventions

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.

Also known as: Motor control exercise A
Experimental group 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.

Also known as: Motor control exercise B
Experimental group B

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola Superior de Saúde - Instituto Politécnico do Porto

Porto, 4200-072, Portugal

Location

Related Publications (3)

  • 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.

    PMID: 21589673BACKGROUND
  • 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.

    PMID: 22134697BACKGROUND
  • 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.

    PMID: 24139017BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 30, 2021

First Posted

February 4, 2021

Study Start

February 1, 2021

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

August 31, 2021

Record last verified: 2021-08

Locations