- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04845802
Effects of Inspiratory Muscle Training on Diaphragm Thickness, Respiratory Muscle Strength and Balance in Dancers.
April 13, 2021 updated by: Hakan Aksu, Istanbul University
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 Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hakan Aksu
- Phone Number: +90 5332165106
- Email: fizyoterapistha@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Dancer (for least two years)
- Stable clinical condition (no injury in last 2 months)
Exclusion Criteria:
- Documented diagnosis of vestibular, neurological or orthopedic disorders which may affect balance and mobility
- Having of chronic pulmonary disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Training 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.
|
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 Names:
|
Sham Comparator: Sham 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.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Eight weeks
|
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.
|
Eight weeks
|
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.
|
Eight weeks
|
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.
|
Eight weeks
|
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.
|
Eight weeks
|
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.
|
Eight weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of baseline biering-sorenson test score after 8 weeks
Time Frame: Eight weeks
|
Eight weeks
|
Change of baseline oswestry disability index after 8 weeks
Time Frame: Eight weeks
|
Eight weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sensu Dincer, Dr., Istanbul University Faculty of Medicine Sports Medicine Department
- Principal Investigator: Turker Sahinkaya, Lecturer, Istanbul University Faculty of Medicine Sports Medicine Department
- Study Director: Bulent Bayraktar, Prof. Dr., Istanbul University Faculty of Medicine Sports Medicine Department
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ferraro 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.
- 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.
- Watson 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2021
Primary Completion (Anticipated)
September 1, 2021
Study Completion (Anticipated)
October 1, 2021
Study Registration Dates
First Submitted
April 12, 2021
First Submitted That Met QC Criteria
April 13, 2021
First Posted (Actual)
April 15, 2021
Study Record Updates
Last Update Posted (Actual)
April 15, 2021
Last Update Submitted That Met QC Criteria
April 13, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Iuhaksu01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Patients may not want to share the data with anyone other than the researchers involved in the study.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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