- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05982210
The Influence of the Diaphragm Muscle and Pain Perception on Lower Limb Neuromuscular Control in Sports Practice.
The Influence of the Diaphragm Muscle and Pain Perception on Lower Limb Neuromuscular Control Parameters in Sports Practice: Application of Breathing Exercises and Manual Therapy of the Diaphragm Muscle and Ribs Protocol
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imma Vergara
- Phone Number: +34 637 03 13 54
- Email: immavergara@uic.es
Study Locations
-
-
Barcelona
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Sant Cugat Del Vallès, Barcelona, Spain, 08195
- Recruiting
- Universitat Internacional de Catalunya
-
Contact:
- Imma Vergara
- Phone Number: +34 637 03 13 54
- Email: immavergara@uic.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
The Control Group does not have any interventions applied.
|
|
|
Experimental: Intervention Group
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rib Cage Mobility
Time Frame: Week 0, Week 4 and Week 9
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lower Limb Power
Time Frame: Week 0, Week 4 and Week 9
|
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
|
|
Lower Limb Stability
Time Frame: Week 0, Week 4 and Week 9
|
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
|
|
Pain Perception
Time Frame: Week 0, Week 4 and Week 9
|
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
|
Collaborators and Investigators
Investigators
- Study Director: María Caridad Bagur, Universitat Internacional de Catalunya
- Study Director: Xantal Borràs, Universitat de Vic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FIS-2022-13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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