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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05687955




Registration number
NCT05687955
Ethics application status
Date submitted
4/01/2023
Date registered
18/01/2023

Titles & IDs
Public title
Exercise Rehabilitation for Hip-related Pain and Dysfunction in Student Circus Arts Performers
Scientific title
Exercise Rehabilitation for Hip-related Pain and Dysfunction in Full Time Student Circus Arts Performers: a Pilot Trial
Secondary ID [1] 0 0
SwinburneUT
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Dysplasia 0 0
Femoro Acetabular Impingement 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Hip Exercise Program

Experimental: Hip Exercise Program - A 12-week strength exercise protocol has been specifically designed to focus on hip rehabilitation appropriate for circus performance.


Other interventions: Hip Exercise Program
The exercise intervention is being implemented 3 times per week. Two sessions can be completed at home by the participant, and one session per week will be attended by a physiotherapist that will monitor exercise technique and progress the exercise program for each participant. The exercise protocol has been specifically designed to focus on hip rehabilitation appropriate for circus performance. The exercise program will involve hip strength exercises in the sagittal, coronal and transverse planes using weights and elastic bands (Theraband). It will also include trunk strength and postural correction exercises to address swayback posture which is a common clinical presentation in those with hip dysplasia.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Copenhagen Hip and Groin Outcome Score (HAGOS)
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
The Copenhagen Hip and Groin Outcome Score (HAGOS)
Timepoint [2] 0 0
3-months
Primary outcome [3] 0 0
The Copenhagen Hip and Groin Outcome Score (HAGOS)
Timepoint [3] 0 0
6-months
Primary outcome [4] 0 0
The Copenhagen Hip and Groin Outcome Score (HAGOS)
Timepoint [4] 0 0
9-months
Primary outcome [5] 0 0
International Hip Outcome Tool (iHOT-12)
Timepoint [5] 0 0
Baseline
Primary outcome [6] 0 0
International Hip Outcome Tool (iHOT-12)
Timepoint [6] 0 0
3-months
Primary outcome [7] 0 0
International Hip Outcome Tool (iHOT-12)
Timepoint [7] 0 0
6-months
Primary outcome [8] 0 0
International Hip Outcome Tool (iHOT-12)
Timepoint [8] 0 0
9-months
Primary outcome [9] 0 0
European Quality of life questionnaire (EQ-5D-5L)
Timepoint [9] 0 0
Baseline
Primary outcome [10] 0 0
European Quality of life questionnaire (EQ-5D-5L)
Timepoint [10] 0 0
3-months
Primary outcome [11] 0 0
European Quality of life questionnaire (EQ-5D-5L)
Timepoint [11] 0 0
6-months
Primary outcome [12] 0 0
European Quality of life questionnaire (EQ-5D-5L)
Timepoint [12] 0 0
9-months
Primary outcome [13] 0 0
Tampa Scale of Kinesiophobia (TSK)
Timepoint [13] 0 0
Baseline
Primary outcome [14] 0 0
Tampa Scale of Kinesiophobia (TSK)
Timepoint [14] 0 0
3-months
Primary outcome [15] 0 0
Tampa Scale of Kinesiophobia (TSK)
Timepoint [15] 0 0
6-months
Primary outcome [16] 0 0
Tampa Scale of Kinesiophobia (TSK)
Timepoint [16] 0 0
9-months
Primary outcome [17] 0 0
Hip Strength assessment
Timepoint [17] 0 0
Baseline
Primary outcome [18] 0 0
Hip Strength assessment
Timepoint [18] 0 0
9-months
Primary outcome [19] 0 0
Hip Range of Motion
Timepoint [19] 0 0
Baseline
Primary outcome [20] 0 0
Hip Range of Motion
Timepoint [20] 0 0
9-months
Secondary outcome [1] 0 0
Functional movement screen Y-balance test
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
Functional movement screen Y-balance test
Timepoint [2] 0 0
9-months
Secondary outcome [3] 0 0
Single leg Hop for distance
Timepoint [3] 0 0
Baseline
Secondary outcome [4] 0 0
Single leg Hop for distance
Timepoint [4] 0 0
9-months
Secondary outcome [5] 0 0
Trunk Muscle Endurance Test
Timepoint [5] 0 0
Baseline
Secondary outcome [6] 0 0
Trunk Muscle Endurance Test
Timepoint [6] 0 0
9-months
Secondary outcome [7] 0 0
One leg rise test
Timepoint [7] 0 0
Baseline
Secondary outcome [8] 0 0
One leg rise test
Timepoint [8] 0 0
9-months

Eligibility
Key inclusion criteria
* 3-month history hip/groin pain +/- symptoms including clicking, giving way, locking, or catching, one or more of a positive
* positive FADIR pain provocation test
* positive HEER test (hip extension and external rotation)
* positive prone instability test
* imaging to support a pathological hip (e.g., CAM morphology, hip dysplasia)
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* OA degree >1 on classification of Tönnis
* Centre Edge-angle <10 degrees
* Legg-Calvé-Perthes or epiphysiolysis
* history of hip joint surgery or significant hip trauma (fracture +/- dislocation)
* neurologic motor deficit (lower limb power, strength or reflex deficit)
* hip pain from a lumbar origin (positive passive straight leg raise, combined lumbar extension and rotation)
* connective tissue disorder (e.g., Ehlers-danlos or Marfan syndrome)
* pregnancy or breastfeeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/03/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Swinburne University of Technology - Hawthorn
Recruitment postcode(s) [1] 0 0
3122 - Hawthorn

Funding & Sponsors
Primary sponsor type
Other
Name
Swinburne University of Technology
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Institute of Circus Arts
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05687955