Diaphragm; RelaxationNCT05982210
The Influence of the Diaphragm Muscle and Pain Perception on Lower Limb Neuromuscular Control in Sports Practice.
A study testing Breathing Exercises and Manual Therapy of the Muscle Diaphragm and Ribs Protocol in people with Diaphragm; Relaxation, run by Universitat Internacional de Catalunya at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Diaphragm; Relaxation
- What is being tested?
- Breathing Exercises and Manual Therapy of the Muscle Diaphragm and Ribs Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jul 2023to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
Imma Vergara, +34 637 03 13 54, immavergara@uic.es
About this study
Official title: 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
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.
Read the detailed 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.
- Conditions
- Diaphragm; Relaxation
- Being tested
- Breathing Exercises and Manual Therapy of the Muscle Diaphragm and Ribs Protocol
- Keywords
- Core Stability, Diaphragm Muscle, Rib Cage, Breathing Biomechanics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing Exercises and Manual Therapy of the Muscle Diaphragm and Ribs ProtocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Breathing Exercises and Manual Therapy of the Muscle Diaphragm and Ribs Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0, Week 4 and Week 9
Secondary outcomes (3)
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.
Measured: Week 0, Week 4 and Week 9
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.
Measured: Week 0, Week 4 and Week 9
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.
Measured: Week 0, Week 4 and Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start15 Jul 2023
- Primary completionJun 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragm; RelaxationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imma Vergara Busquets, Universitat Internacional de Catalunya
- Investigators
- María Caridad Bagur, Study director, Universitat Internacional de CatalunyaXantal Borràs, Study director, Universitat de Vic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982210
- Sponsor's protocol ID
- FIS-2022-13
- Status last verified
- Aug 2023
- First submitted
- 29 Jul 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05982210
- Acronym / sponsor ID
- FIS-2022-13
- Conditions
- Diaphragm; Relaxation
- Keywords
- Core Stability, Diaphragm Muscle, Rib Cage, Breathing Biomechanics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The Control Group does not have any interventions applied. |
| Intervention Group | Experimental | Other: Breathing Exercises and Manual Therapy of the Muscle Diaphragm and Ribs ProtocolThe 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing Exercises and Manual Therapy of the Muscle Diaphragm and Ribs ProtocolThe 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. | Other | Intervention Group |
Primary outcome
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.
3 secondary outcomes
Lower Limb Power
Time frame: Week 0, Week 4 and Week 9
Lower Limb Stability
Time frame: Week 0, Week 4 and Week 9
Pain Perception
Time frame: Week 0, Week 4 and Week 9
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María Caridad Bagur study director
Universitat Internacional de Catalunya
Xantal Borràs study director
Universitat de Vic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing Exercises and Manual Therapy of the Muscle Diaphragm and Ribs Protocol in people with Diaphragm; Relaxation, run by Universitat Internacional de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imma Vergara (+34 637 03 13 54, immavergara@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rib Cage Mobility (time frame: Week 0, Week 4 and Week 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.