NCT05982210

Brief Summary

Core stability is maintained mainly by muscle function of abdominal and lumbar region, including the diaphragm muscle. It is known that exists a connection between trunk's muscle activity and the movement of lower limb and lower limb and low back injuries are related to core alterations. Thus, a randomized clinical trial is planned to analyze the effectiveness of an exercises and manual therapy of the diaphragm and ribs program designed, aiming to analyze the correlation between rib cage mobility and lower limb neuromuscular control in young healthy subjects.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

August 8, 2023

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

July 29, 2023

Last Update Submit

August 4, 2023

Conditions

Keywords

Core StabilityDiaphragm MuscleRib CageBreathing Biomechanics

Outcome Measures

Primary Outcomes (1)

  • Rib Cage Mobility

    The the rib cage mobility is assessed using a measuring tape. The measuring tape assess the diameter of the rib cage between a maximal inspiration and maximal expiration. Two anatomical marks are described: the superior mark is formed by the third intercostal space, de clavicular line and spinous apophysis of the thoracic vertebra number five; and the inferior mark is formed by xiphoid process and the spinous apophysis of the thoracic vertebra number ten. The subjects stand with the hands on the head and the evaluator mantains the measuring tape around the rib cage of the subject. The subject inhales by the nose expanding the lungs and exhales by the mouth until the lungs are empty. The measures are taken three times, at the beginning of each inspiratory and expiratory cycle. The repetition is failed if the subject makes an apnea or cough.

    Week 0, Week 4 and Week 9

Secondary Outcomes (3)

  • Lower Limb Power

    Week 0, Week 4 and Week 9

  • Lower Limb Stability

    Week 0, Week 4 and Week 9

  • Pain Perception

    Week 0, Week 4 and Week 9

Study Arms (2)

Control Group

NO INTERVENTION

The Control Group does not have any interventions applied.

Intervention Group

EXPERIMENTAL

The Intervention Group will take part in the experimental process. A clinical practice protocol about breathing exercises and diaphragm and ribs manual therapy will be applied, in a total duration of 15 minutes, twice a week during eight weeks.

Other: Breathing Exercises and Manual Therapy of the Muscle Diaphragm and Ribs Protocol

Interventions

The intervention consists on applying a protocol based on five different exercises, compound by breathing exercises and manual therapy of the muscle diaphragm and the ribs, applied by a physiotherapist.

Intervention Group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Physical Activity Practice: at least 150-300min of moderate activity or 75-100min of intense aerobic activity, twice a week.
  • Physical activity or sports practice involve mostly lower limb muscles activation.
  • Core Stability exercises least twice a week. Includes at least 3 of the 6 exercises listed: bridge exercises, standard plank, lateral plank, superman exercise, mountain climber and plank variations.

You may not qualify if:

  • Musculoskeletal injury currently or in the past 6 months.
  • Abdominal or thoracic surgery.
  • Nervous System disease.
  • Hiatal Hernia or visceral disease.
  • Pelvic floor alterations or disease.
  • Breathing restrictions: disease or infection, asthma, anxiety or other non controlled alterations.
  • Treatment of the diaphragm muscle the past 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

RECRUITING

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • María Caridad Bagur

    Universitat Internacional de Catalunya

    STUDY DIRECTOR
  • Xantal Borràs

    Universitat de Vic

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

July 29, 2023

First Posted

August 8, 2023

Study Start

July 15, 2023

Primary Completion

June 1, 2024

Study Completion

January 1, 2025

Last Updated

August 8, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations