NCT04845802

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 15, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

April 15, 2021

Status Verified

April 1, 2021

Enrollment Period

4 months

First QC Date

April 12, 2021

Last Update Submit

April 13, 2021

Conditions

Keywords

Inspiratory Muscle TrainingDiaphragmRespiratory Muscle StrengthBalanceDancer

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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.

    Eight weeks

Secondary Outcomes (2)

  • Change of baseline biering-sorenson test score after 8 weeks

    Eight weeks

  • Change of baseline oswestry disability index after 8 weeks

    Eight weeks

Study Arms (2)

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.

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.

Other: Inspiratory muscle training(low-IMT group)

Interventions

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.

Also known as: [high-IMT group]
Training 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.

Also known as: [low-IMT group]
Sham Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dancer (for least two years)
  • Stable clinical condition (no injury in last 2 months)

You may not qualify if:

  • Documented diagnosis of vestibular, neurological or orthopedic disorders which may affect balance and mobility
  • Having of chronic pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 24870567BACKGROUND
  • 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.

    PMID: 31074198BACKGROUND
  • 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.

    PMID: 28217414BACKGROUND

MeSH Terms

Conditions

Athletic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Sensu Dincer, Dr.

    Istanbul University Faculty of Medicine Sports Medicine Department

    PRINCIPAL INVESTIGATOR
  • Turker Sahinkaya, Lecturer

    Istanbul University Faculty of Medicine Sports Medicine Department

    PRINCIPAL INVESTIGATOR
  • Bulent Bayraktar, Prof. Dr.

    Istanbul University Faculty of Medicine Sports Medicine Department

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, MSc Student in Exercise Physiology

Study Record Dates

First Submitted

April 12, 2021

First Posted

April 15, 2021

Study Start

May 1, 2021

Primary Completion

September 1, 2021

Study Completion

October 1, 2021

Last Updated

April 15, 2021

Record last verified: 2021-04