Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000411549
Ethics application status
Approved
Date submitted
16/03/2024
Date registered
4/04/2024
Date last updated
4/04/2024
Date data sharing statement initially provided
4/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation of the effects of exercise on walking economy in individuals with osteoarthritis of the hip
Scientific title
An investigation of the effects of exercise on walking economy in individuals with osteoarthritis of the hip
Secondary ID [1] 311751 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Osteoarthritis 333247 0
Condition category
Condition code
Physical Medicine / Rehabilitation 329936 329936 0 0
Physiotherapy
Musculoskeletal 330033 330033 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 weeks of neuro motor exercises in a group setting.
The intervention will use a neuro motor exercise program to improve walking economy. Participants assigned to the exercise intervention will be asked to complete a minimum of two group exercise classes per week at either the participating YMCA in Downers Grove, Illinois, or the gym in the School of Kinesiology at the University of Fraser Valley, Chilliwack, British Columbia.
The classes will be open to the public. Similar classes attract approximately 10 - 20 participants. Each class is 45 minutes in duration.
Classes will be taught by qualified group exercise instructors who will be trained in the delivery of the program and how to modify the exercises, in respect to intensity and balance requirements.
The classes are prechoreographed and consist of a warm-up, followed by a squat track, standing core exercises such as woodchops, standing hip exercises with the option to use exercise tubing resistance, lunges track, lying gluteal exercises, lying core exercises and a flexibility track.
The program is an adaptation of a neuromuscular exercise (NEMEX) protocol for a group exercise environment.
Adherence will be monitored via a weekly training diary.
Intervention code [1] 328207 0
Rehabilitation
Comparator / control treatment
Usual care
Participants allocated to the control group will be instructed to continue with their usual care and behaviors. No restrictions will be placed on commencing new management strategies related to hip joint OA during the 12-week intervention.
Control group
Active

Outcomes
Primary outcome [1] 337697 0
Walking economy
Timepoint [1] 337697 0
Baseline, and 12 weeks (at completion of the intervention).
Secondary outcome [1] 432896 0
Cadence
Timepoint [1] 432896 0
Baseline and 12 weeks (at the completion of the intervention)
Secondary outcome [2] 433328 0
Lower Limb Strength
Timepoint [2] 433328 0
Baseline and 12 weeks (at the completion of the intervention)
Secondary outcome [3] 433566 0
Step Length
Timepoint [3] 433566 0
Baseline and 12 weeks (at the completion of the inetrvention)
Secondary outcome [4] 433567 0
Step width
Timepoint [4] 433567 0
Baseline and 12 weeks (at the completion of the intervention)
Secondary outcome [5] 433568 0
Stride duration
Timepoint [5] 433568 0
Baseline and 12 weeks (at the completion of the intervention)
Secondary outcome [6] 433569 0
Stance duration
Timepoint [6] 433569 0
Baseline and 12 weeks (at the completion of the intervention)
Secondary outcome [7] 433570 0
Swing duration
Timepoint [7] 433570 0
Baseline and 12 weeks (at the completion of the intervention)
Secondary outcome [8] 433571 0
Double support duration
Timepoint [8] 433571 0
Baseline and 12 weeks (at the completion of the intervention)

Eligibility
Key inclusion criteria
Osteoarthritis of the hip
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other musculoskeletal lower limb or back conditions requiring assessment or treatment in the last 6 months.
History of hip trauma or surgery on either the affected or unaffected side.
Corticosteroid use (oral or intra-articular) in the past 3 months.
Neurological impairment or condition affecting lower limb function.
Routine use of gait aids, uncontrolled hypertension, or morbid obesity (BMI > 40).
Systemic inflammatory disease (e.g., rheumatoid arthritis).
Chronic respiratory diseases, and cardiac conditions that will restrict the assessment of walking economy, eg chronic bronchitis, chronic obstructive pulmonary disease, heart disease.
Unable to write, read or comprehend English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation based on age, sex and exercise history
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A power analysis was conducted to determine the sample size.
Treatment effects will be calculated via ANOVA

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
1/09/2024
Actual
Date of last data collection
Anticipated
20/12/2024
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment outside Australia
Country [1] 26203 0
United States of America
State/province [1] 26203 0
Illinois
Country [2] 26204 0
Canada
State/province [2] 26204 0
British Colombia

Funding & Sponsors
Funding source category [1] 316083 0
Commercial sector/Industry
Name [1] 316083 0
Les Mills International
Country [1] 316083 0
New Zealand
Funding source category [2] 316084 0
University
Name [2] 316084 0
Auckland University of Technology
Country [2] 316084 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Country
New Zealand
Secondary sponsor category [1] 318250 0
University
Name [1] 318250 0
University of Fraser Valley
Address [1] 318250 0
Country [1] 318250 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314904 0
Auckland University of Technology Ethics Committee
Ethics committee address [1] 314904 0
https://www.aut.ac.nz/research/researchethics
Ethics committee country [1] 314904 0
New Zealand
Date submitted for ethics approval [1] 314904 0
16/10/2023
Approval date [1] 314904 0
13/12/2023
Ethics approval number [1] 314904 0
23/252

Summary
Brief summary
This study will investigate the effects of a 12 week exercise program on walking economy in individuals with osteoarthritis of the hip. It is hypothesized that a 12 week exercise program will improve walking economy in individuals with osteoarthritis of the hip.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133106 0
Mr Bryce Hastings
Address 133106 0
Les Mills International, 363 West Erie Street, Chicago, Illinois 60654
Country 133106 0
United States of America
Phone 133106 0
+1 773 255 3336
Fax 133106 0
Email 133106 0
bryce.hastings@lesmills.com
Contact person for public queries
Name 133107 0
Bryce Hastings
Address 133107 0
Les Mills International, 363 West Erie Street, Chicago, Illinois 60654
Country 133107 0
United States of America
Phone 133107 0
+1 773 255 3336
Fax 133107 0
Email 133107 0
bryce.hastings@lesmills.com
Contact person for scientific queries
Name 133108 0
Bryce Hastings
Address 133108 0
Les Mills International, 363 West Erie Street, Chicago, Illinois 60654
Country 133108 0
United States of America
Phone 133108 0
+1 773 255 3336
Fax 133108 0
Email 133108 0
bryce.hastings@lesmills.com

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.