Athletic InjuriesNCT04845802
Effects of Inspiratory Muscle Training on Diaphragm Thickness, Respiratory Muscle Strength and Balance in Dancers.
A study testing Inspiratory muscle training(high-IMT group) and Inspiratory muscle training(low-IMT group) in people with Athletic Injuries, run by Istanbul University.
Trial summary
Dance is a performing art form consisting of sports and art intertwined and complex dynamic choreographic figures were handled aesthetically and physically of narrative. Scientific studies are insufficient on dance and health and performance of dancers in the literature although dance is the most used type of art and… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Athletic Injuries
- What is being tested?
- Inspiratory muscle training(high-IMT group) and Inspiratory muscle training(low-IMT group)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Oct 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dancer (for least two years)
- Stable clinical condition (no injury in last 2 months)
Who cannot join
- Documented diagnosis of vestibular, neurological or orthopedic disorders which may affect balance and mobility
- Having of chronic pulmonary disease
Trial locations and contacts
No sites are listed yet.
About this study
Dance is a performing art form consisting of sports and art intertwined and complex dynamic choreographic figures were handled aesthetically and physically of narrative. Scientific studies are insufficient on dance and health and performance of dancers in the literature although dance is the most used type of art and sport in all societies and for all age groups. It is seen that the core stabilization (central forces) of the dancers is insufficient when the current studies were examined, this insufficient stabilization causes biomechanical changes in the trunk, and indirectly affects the lower extremities. Consequently, insufficient stabilization was shown to be caused impairment of force generation and injuries. In addition, lack of core stabilization of dancers may cause impairment in balance and postural control. Therefore, dancers need a good postural control with provided by an effective core stabilization training in order to exhibit a successful and healthy performance. It is shown that inspiratory muscle training (IMT) improves diaphragm strength and diaphragm thickness. Considering the relation between diaphragm muscle forming the upper (ceiling) part of the core area, and balance, IMT may also have an impact on postural control and balance alongside the standard clinical parameters such as respiratory muscle strength and diaphragm thickness in dancers. Thus, the aim of this study was to investigate the effects of inspiratory muscle training on diaphragm thickness, postural stability, balance, respiratory muscle strength in dancers.
- Conditions
- Athletic Injuries
- Being tested
- Inspiratory muscle training(high-IMT group), Inspiratory muscle training(low-IMT group)
- Keywords
- Inspiratory Muscle Training, Diaphragm, Respiratory Muscle Strength, Balance, Dancer
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle training(high-IMT group)Other
Also called [high-IMT group]
A mechanical pressure threshold loading device (POWERbreathe, POWERbreathe International Ltd, UK) will be used for the training. Training intensity will set at 60% of the maximum inspiratory pressure.
Inspiratory muscle training(low-IMT group)Other
Also called [low-IMT group]
Dancers will be perform at a load setting of level 1 (corresponding to ~10% baseline MIP), using the same device as the training group.
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | Dancers in this group will perform inspiratory muscle training for 30 breaths, twice daily [morning: between 7:00 and 13:00 and evening: between 16:00 and 22:00], 7 days per week for 8 weeks, with a breathing frequency of 15 breaths per minute and a duty cycle of 0.5. One exercise session will be supervised in a clinic per week, other sessions will be performed at home in every week during the training. Receives: Other: Inspiratory muscle training(high-IMT group) |
| Sham Group | Sham comparator | Dancers in this group will perform inspiratory muscle training for 30 breaths, twice daily [morning: between 7:00 and 13:00 and evening: between 16:00 and 22:00], 7 days per week for 8 weeks, with a breathing frequency of 15 breaths per minute and a duty cycle of 0.5. One exercise session will be supervised in a clinic per week, other sessions will be performed at home in every week during the training. Receives: Other: Inspiratory muscle training(low-IMT group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of baseline postural stability test score in Biodex Balance System after 8 weeks
The Postural Stability Test evaluates static balance of participants. Postural Stability Test emphasizes a patient's ability to maintain center of balance. The patient's score on this test assesses deviations from center, thus a lower score is more desirable than a higher score.
Measured: Eight weeks
Change of baseline athlete single leg stability score in Biodex Balance System after 8 weeks
The test protocol for the Athlete Single Leg Stability Testing allows clinicians to test athletes against data derived from studies using the Biodex Balance System. The stability level will challenge athletes and provide the data necessary to assess the athlete's single leg postural stability.
Measured: Eight weeks
Change of baseline limits of stability test score in Biodex Balance System after 8 weeks
Limits of stability test evaluates dynamic balance of participants. Biodex balance system measures limits of stability for forward, backward, right and left side movements. It will calculate the maximum distance a person can lean without losing balance.
Measured: Eight weeks
Change of baseline diaphragm thickness after 8 weeks
Two-dimensional B-mode ultrasound will be measure diaphragm thickness at the zone of apposition during inspiration or expiration using the intercostal approach. Diaphragm thickness will be measure as the vertical distance between the pleural and peritoneal layer at both Total Lung Capacity [TLC] and Functional Residual Capacity [FRC]. Measurements will be perform on the right hemidiaphragm with the volunteer in the supine position. All measurements will be perform 3 times and the average value for each calculate.
Measured: Eight weeks
Change of baseline maximum inspiratory pressure after 8 weeks
Maximum inspiratory pressure (MIP) will be measure using a hand-held mouth pressure device. Three maximal manoeuvres will perform and the highest value record. Indirect measure of respiratory (inspiratory) muscle strength, expressed in cmH20.
Measured: Eight weeks
Change of baseline maximum expiratory pressure after 8 weeks
Maximum expiratory pressure (MEP) will be measure using a hand-held mouth pressure device. Three maximal manoeuvres will perform and the highest value record. Indirect measure of respiratory (expiratory) muscle strength, expressed in cmH20.
Measured: Eight weeks
Secondary outcomes (2)
Change of baseline biering-sorenson test score after 8 weeks
Measured: Eight weeks
Change of baseline oswestry disability index after 8 weeks
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study startMay 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Athletic InjuriesStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Aksu, Istanbul University
- Investigators
- Sensu Dincer, Dr., Principal investigator, Istanbul University Faculty of Medicine Sports Medicine DepartmentTurker Sahinkaya, Lecturer, Principal investigator, Istanbul University Faculty of Medicine Sports Medicine DepartmentBulent Bayraktar, Prof. Dr., Study director, Istanbul University Faculty of Medicine Sports Medicine Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845802
- Sponsor's protocol ID
- Iuhaksu01
- Status last verified
- Apr 2021
- First submitted
- 12 Apr 2021
- Last updated
- 15 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Patients may not want to share the data with anyone other than the researchers involved in the study.
Publications
Janssens L, McConnell AK, Pijnenburg M, Claeys K, Goossens N, Lysens R, Troosters T, Brumagne S. Inspiratory muscle training affects proprioceptive use and low back pain. Med Sci Sports Exerc. 2015 Jan;47(1):12-9. doi: 10.1249/MSS.0000000000000385.
PubMed 24870567Ferraro FV, Gavin JP, Wainwright T, McConnell A. The effects of 8 weeks of inspiratory muscle training on the balance of healthy older adults: a randomized, double-blind, placebo-controlled study. Physiol Rep. 2019 May;7(9):e14076. doi: 10.14814/phy2.14076.
PubMed 31074198Watson T, Graning J, McPherson S, Carter E, Edwards J, Melcher I, Burgess T. DANCE, BALANCE AND CORE MUSCLE PERFORMANCE MEASURES ARE IMPROVED FOLLOWING A 9-WEEK CORE STABILIZATION TRAINING PROGRAM AMONG COMPETITIVE COLLEGIATE Dancers. Int J Sports Phys Ther. 2017 Feb;12(1):25-41.
PubMed 28217414
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training on Diaphragm Thickness, Respiratory Muscle Strength and Balance in Dancers.
- ClinicalTrials.gov ID
- NCT04845802
- Acronym / sponsor ID
- Iuhaksu01
- Conditions
- Athletic Injuries
- Keywords
- Inspiratory Muscle Training, Diaphragm, Respiratory Muscle Strength, Balance, Dancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 15 Apr 2021 (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.
Dance is a performing art form consisting of sports and art intertwined and complex dynamic choreographic figures were handled aesthetically and physically of narrative. Scientific studies are insufficient on dance and health and performance of dancers in the literature although dance is the most used type of art and sport in all societies and for all age groups. It is seen that the core stabilization (central forces) of the dancers is insufficient when the current studies were examined, this insufficient stabilization causes biomechanical changes in the trunk, and indirectly affects the lower extremities. Consequently, insufficient stabilization was shown to be caused impairment of force generation and injuries. In addition, lack of core stabilization of dancers may cause impairment in balance and postural control. Therefore, dancers need a good postural control with provided by an effective core stabilization training in order to exhibit a successful and healthy performance. It is shown that inspiratory muscle training (IMT) improves diaphragm strength and diaphragm thickness. Considering the relation between diaphragm muscle forming the upper (ceiling) part of the core area, and balance, IMT may also have an impact on postural control and balance alongside the standard clinical parameters such as respiratory muscle strength and diaphragm thickness in dancers. Thus, the aim of this study was to investigate the effects of inspiratory muscle training on diaphragm thickness, postural stability, balance, respiratory muscle strength in dancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Other: Inspiratory muscle training(high-IMT group)Dancers in this group will perform inspiratory muscle training for 30 breaths, twice daily [morning: between 7:00 and 13:00 and evening: between 16:00 and 22:00], 7 days per week for 8 weeks, with a breathing frequency of 15 breaths per minute and a duty cycle of 0.5. One exercise session will be supervised in a clinic per week, other sessions will be performed at home in every week during the training. |
| Sham Group | Sham comparator | Other: Inspiratory muscle training(low-IMT group)Dancers in this group will perform inspiratory muscle training for 30 breaths, twice daily [morning: between 7:00 and 13:00 and evening: between 16:00 and 22:00], 7 days per week for 8 weeks, with a breathing frequency of 15 breaths per minute and a duty cycle of 0.5. One exercise session will be supervised in a clinic per week, other sessions will be performed at home in every week during the training. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Dancer (for least two years)
- Stable clinical condition (no injury in last 2 months)
Key exclusion criteria (2 listed)
- Documented diagnosis of vestibular, neurological or orthopedic disorders which may affect balance and mobility
- Having of chronic pulmonary 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 |
|---|---|---|
| Inspiratory muscle training(high-IMT group)Also: [high-IMT group]A mechanical pressure threshold loading device (POWERbreathe, POWERbreathe International Ltd, UK) will be used for the training. Training intensity will set at 60% of the maximum inspiratory pressure. | Other | Training Group |
| Inspiratory muscle training(low-IMT group)Also: [low-IMT group]Dancers will be perform at a load setting of level 1 (corresponding to ~10% baseline MIP), using the same device as the training group. | Other | Sham Group |
Primary outcome
Change of baseline postural stability test score in Biodex Balance System after 8 weeks
Time frame: Eight weeks
The Postural Stability Test evaluates static balance of participants. Postural Stability Test emphasizes a patient's ability to maintain center of balance. The patient's score on this test assesses deviations from center, thus a lower score is more desirable than a higher score.
Change of baseline athlete single leg stability score in Biodex Balance System after 8 weeks
Time frame: Eight weeks
The test protocol for the Athlete Single Leg Stability Testing allows clinicians to test athletes against data derived from studies using the Biodex Balance System. The stability level will challenge athletes and provide the data necessary to assess the athlete's single leg postural stability.
Change of baseline limits of stability test score in Biodex Balance System after 8 weeks
Time frame: Eight weeks
Limits of stability test evaluates dynamic balance of participants. Biodex balance system measures limits of stability for forward, backward, right and left side movements. It will calculate the maximum distance a person can lean without losing balance.
Change of baseline diaphragm thickness after 8 weeks
Time frame: Eight weeks
Two-dimensional B-mode ultrasound will be measure diaphragm thickness at the zone of apposition during inspiration or expiration using the intercostal approach. Diaphragm thickness will be measure as the vertical distance between the pleural and peritoneal layer at both Total Lung Capacity [TLC] and Functional Residual Capacity [FRC]. Measurements will be perform on the right hemidiaphragm with the volunteer in the supine position. All measurements will be perform 3 times and the average value for each calculate.
Change of baseline maximum inspiratory pressure after 8 weeks
Time frame: Eight weeks
Maximum inspiratory pressure (MIP) will be measure using a hand-held mouth pressure device. Three maximal manoeuvres will perform and the highest value record. Indirect measure of respiratory (inspiratory) muscle strength, expressed in cmH20.
Change of baseline maximum expiratory pressure after 8 weeks
Time frame: Eight weeks
Maximum expiratory pressure (MEP) will be measure using a hand-held mouth pressure device. Three maximal manoeuvres will perform and the highest value record. Indirect measure of respiratory (expiratory) muscle strength, expressed in cmH20.
2 secondary outcomes
Change of baseline biering-sorenson test score after 8 weeks
Time frame: Eight weeks
Change of baseline oswestry disability index after 8 weeks
Time frame: Eight weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Background: PubMed 24870567Janssens L, McConnell AK, Pijnenburg M, Claeys K, Goossens N, Lysens R, Troosters T, Brumagne S. Inspiratory muscle training affects proprioceptive use and low back pain. Med Sci Sports Exerc. 2015 Jan;47(1):12-9. doi: 10.1249/MSS.0000000000000385.
- Background: PubMed 31074198Ferraro FV, Gavin JP, Wainwright T, McConnell A. The effects of 8 weeks of inspiratory muscle training on the balance of healthy older adults: a randomized, double-blind, placebo-controlled study. Physiol Rep. 2019 May;7(9):e14076. doi: 10.14814/phy2.14076.
- Background: PubMed 28217414Watson T, Graning J, McPherson S, Carter E, Edwards J, Melcher I, Burgess T. DANCE, BALANCE AND CORE MUSCLE PERFORMANCE MEASURES ARE IMPROVED FOLLOWING A 9-WEEK CORE STABILIZATION TRAINING PROGRAM AMONG COMPETITIVE COLLEGIATE Dancers. Int J Sports Phys Ther. 2017 Feb;12(1):25-41.
- Individual participant dataSharing planned: Undecided. Patients may not want to share the data with anyone other than the researchers involved in the study.
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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.
Sensu Dincer, Dr. principal investigator
Istanbul University Faculty of Medicine Sports Medicine Department
Turker Sahinkaya, Lecturer principal investigator
Istanbul University Faculty of Medicine Sports Medicine Department
Bulent Bayraktar, Prof. Dr. study director
Istanbul University Faculty of Medicine Sports Medicine Department
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training(high-IMT group) and Inspiratory muscle training(low-IMT group) in people with Athletic Injuries, run by Istanbul University.
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 2 inclusion and 2 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 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Hakan Aksu (5332165106 ext. +90, fizyoterapistha@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of baseline postural stability test score in Biodex Balance System after 8 weeks (time frame: Eight weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04845802, which also lists 3 linked publications.
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 15 Apr 2021.