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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05982210
Other study ID # FIS-2022-13
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 15, 2023
Est. completion date January 2025

Study information

Verified date August 2023
Source Universitat Internacional de Catalunya
Contact Imma Vergara
Phone +34 637 03 13 54
Email immavergara@uic.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The aim of the study consists on analysing the correlation between rib cabe mobility and neuromuscular control parameters of lower limb, as well as pain perception in young healthy adults sports players. A clinical practice protocol consisting on breathing exercises and manual therapy of the muscle diaphragm and the ribs will be applied twice a week during eight weeks. As a result, could be an increasement of the neuromuscular control parameters, described with the outcome measures of rib cage mobility, lower limb power and stability, and pain perception. If the results stablish correlation between the rib cage mobility and neuromuscular control parameters of lower limb, could be helpful in healthcare and sports science field in order to take in account the diaphragm biomechanics when treating lower limb injuries and facing its prevention.


Recruitment information / eligibility

Status Recruiting
Enrollment 44
Est. completion date January 2025
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Spain Universitat Internacional de Catalunya Sant Cugat Del Vallès Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Lower Limb Power My Jump Lab App is used to asses lower limb power through jump analysis. The device is fixed with a tripod, 50 centimetres away from the floor, focused on the frontal plane of the subject. The subject makes a CounterMovement Jump (CMJ) which is recorded in 240 frames/second. The subject is standing with shoes and knees extended and the hands on the hips. From this position, the subject quickly makes a knee flexion until 90 degrees followed by a quick knee extension before taking a maximum vertical jump.
After de jump is recorded, the take off frame and the landing frame are indicated in the app, and calculates automatically the power of lower limb.
Three repetitions are recorded from each lower limb.
Week 0, Week 4 and Week 9
Secondary Lower Limb Stability The Star Excursion Balance Test (SEBT) is used to assess lower limb stability. Three tape strips are placed on the floor: anterior (A), posteromedial (PM) and posterolateral (PL), leaving 120 degrees angulation between A and PM/PL, and 90 degrees between PM and PL, converging at the 0 mark.
The participant stands in monopodal position with hands on the hips, without shoes or socks. The anterior part of the foot stays in the 0 mark for the A direction, and the heel por PM and PL. The participant slides the free foot through the tape without touching it until reaching the maximum distance, registrated in centimeters. The repetition is failed if the participant touches the floor, move the baseline foot or touches the tape more than once.
Three repetitions will be recorded for each lower limb and for each direction. The length of the lower limb is measured with the distance between the anterosuperior iliaca spine and the external tibial malleolus.
Week 0, Week 4 and Week 9
Secondary Pain Perception The Numeric Rating Scale (NRS) is used to assess pain perception. The NRS is a visual scale composed by 11 different numeric points, within the 0 represents inexistent pain and the 10 represents the maximal pain imaginable.
The subject indicates which number adjusts to the pain intensity experimented related to the lower limb.
Week 0, Week 4 and Week 9
See also
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Recruiting NCT05762913 - Effect of the Diaphragm Release Technique on Sleep Duration and Quality N/A
Active, not recruiting NCT06230289 - Effect of Transversus Abdominis Plane Block on Diaphragm Thickness N/A
Recruiting NCT05197907 - Influence of Manual Relaxation of the Diaphragm on the Tension of the Posterior Superficial Fascia N/A