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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
11/08/2024
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
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Scientific title
An investigation of the effects of exercise on walking economy in individuals with osteoarthritis of the hip
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Secondary ID [1]
311751
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hip Osteoarthritis
333247
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Condition category
Condition code
Physical Medicine / Rehabilitation
329936
329936
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0
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Physiotherapy
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Musculoskeletal
330033
330033
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0
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Osteoarthritis
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
328207
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Rehabilitation
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Walking economy
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Assessment method [1]
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Walking VO2
Participants will complete two, 6-minute over ground walking trials as part of a modified Short Physical Performance Battery (SPPB).
After a 5 minute rest period, standing oxygen uptake (VO2) will be measured via a portable gas exchange system (VO2 Master, VO2 Master Health Sensors Inc, Canada) over a 5-minute period.
This will be followed by walking on a treadmill at a comfortable speed for 5 minutes for familiarization with the treadmill. After a further 5 minutes rest, participants will complete 5 minutes of walking at 0.72 m/sec. This speed has been shown to be manageable without being uncomfortably slow.
They will then walk at their preferred gait speed as measured during the SPPB. Oxygen consumption measures for standing and the 2 walking speeds will be averaged for the last 2 minutes of the tests or for 2 minutes once a steady state of oxygen consumption is observed.
The treadmills will be standard gym quality with the make varying in each location.
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Timepoint [1]
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Baseline, and 12 weeks (at completion of the intervention).
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Secondary outcome [1]
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Cadence
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Assessment method [1]
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Data will be collected using OpenCAP via 2 i-phones placed at the rear of the treadmill during the preferred walking speed phase of the treadmill walking economy assessment. Data will be collected via video to measure cadence (steps / minute),
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Timepoint [1]
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Baseline and 12 weeks (at the completion of the intervention)
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Secondary outcome [2]
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Lower Limb Strength
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Assessment method [2]
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Bilateral hip muscle strength of the flexors, extensors, abductors and adductors will be assessed at baseline and 12-weeks using a hand-held dynamometer (Activforce 2 Digital Dynamometer, 66fit NZ). A submaximal test will be used for familiarization followed by 3 maximal tests. Participants will be informed that they can stop any time due to discomfort. Results of the three tests will be recorded and averaged.
An isometric strength test of a mid-thigh pull will be measured at baseline and 12-weeks via a dynamometer attached to a lifting platform (Back-Leg-Chest Dynamometer 3B Scientific USA). . A bar will be held at mid-thigh level and participants will be instructed to “drive your feet into the floor as hard as possible”. 3 readings will be taken with the maximum value recorded.
A wall-sit strength endurance test will be conducted at baseline and 12-weeks. Subjects will be instructed to stand upright with their back against the wall, feet parallel and shoulder-width apart, and hands by their sides. subjects will be instructed to lower their back down the wall until a knee joint angle of 100 degrees flexion is achieved or where they are comfortable. All subjects will be asked to maintain this position until fatigue.
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Timepoint [2]
433328
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Baseline and 12 weeks (at the completion of the intervention)
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Secondary outcome [3]
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Step Length
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Assessment method [3]
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Data will be collected using OpenCAP via 2 i-phones placed at the rear of the treadmill during the preferred walking speed phase of the treadmill walking economy assessment. Data will be collected via video to measure step length (meters)
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Timepoint [3]
433566
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Baseline and 12 weeks (at the completion of the inetrvention)
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Secondary outcome [4]
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Step width
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Assessment method [4]
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Data will be collected using OpenCAP via 2 i-phones placed at the rear of the treadmill during the preferred walking speed phase of the treadmill walking economy assessment. Data will be collected via video to measure step width (meters)
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Timepoint [4]
433567
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Baseline and 12 weeks (at the completion of the intervention)
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Secondary outcome [5]
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Stride duration
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Assessment method [5]
433568
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Data will be collected using OpenCAP via 2 i-phones placed at the rear of the treadmill during the preferred walking speed phase of the treadmill walking economy assessment. Data will be collected via video to measure stride duration (seconds)
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Timepoint [5]
433568
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Baseline and 12 weeks (at the completion of the intervention)
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Secondary outcome [6]
433569
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Stance duration
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Assessment method [6]
433569
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Data will be collected using OpenCAP via 2 i-phones placed at the rear of the treadmill during the preferred walking speed phase of the treadmill walking economy assessment. Data will be collected via video to measure stance duration (seconds).
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Timepoint [6]
433569
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Baseline and 12 weeks (at the completion of the intervention)
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Secondary outcome [7]
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Swing duration
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Assessment method [7]
433570
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Data will be collected using OpenCAP via 2 i-phones placed at the rear of the treadmill during the preferred walking speed phase of the treadmill walking economy assessment. Data will be collected via video to measure swing duration (seconds)
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Timepoint [7]
433570
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Baseline and 12 weeks (at the completion of the intervention)
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Secondary outcome [8]
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Double support duration
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Assessment method [8]
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Data will be collected using OpenCAP via 2 i-phones placed at the rear of the treadmill during the preferred walking speed phase of the treadmill walking economy assessment. Data will be collected via video to measure double support duration (seconds)
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Timepoint [8]
433571
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Baseline and 12 weeks (at the completion of the intervention)
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Eligibility
Key inclusion criteria
Osteoarthritis of the hip
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation based on age, sex and exercise history
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
A power analysis was conducted to determine the sample size.
Treatment effects will be calculated via ANOVA
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
5/08/2024
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Actual
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Date of last participant enrolment
Anticipated
30/06/2025
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Actual
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Date of last data collection
Anticipated
30/09/2025
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Actual
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Sample size
Target
64
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Accrual to date
0
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Final
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Recruitment outside Australia
Country [1]
26203
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United States of America
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State/province [1]
26203
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Illinois
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Country [2]
26204
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Canada
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State/province [2]
26204
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British Colombia
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Funding & Sponsors
Funding source category [1]
316083
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Commercial sector/Industry
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Name [1]
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Les Mills International
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Address [1]
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Country [1]
316083
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New Zealand
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Funding source category [2]
316084
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University
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Name [2]
316084
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Auckland University of Technology
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Address [2]
316084
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Country [2]
316084
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New Zealand
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Primary sponsor type
University
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Name
Auckland University of Technology
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Address
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Country
New Zealand
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Secondary sponsor category [1]
318250
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University
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Name [1]
318250
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University of Fraser Valley
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Address [1]
318250
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Country [1]
318250
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Canada
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
314904
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Auckland University of Technology Ethics Committee
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Ethics committee address [1]
314904
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https://www.aut.ac.nz/research/researchethics
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Ethics committee country [1]
314904
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New Zealand
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Date submitted for ethics approval [1]
314904
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16/10/2023
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Approval date [1]
314904
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13/12/2023
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Ethics approval number [1]
314904
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23/252
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Bryce Hastings
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Address
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Les Mills International, 363 West Erie Street, Chicago, Illinois 60654
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Country
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United States of America
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Phone
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+1 773 255 3336
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Fax
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Email
133106
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[email protected]
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Contact person for public queries
Name
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Bryce Hastings
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Address
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Les Mills International, 363 West Erie Street, Chicago, Illinois 60654
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Country
133107
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United States of America
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Phone
133107
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+1 773 255 3336
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Fax
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Email
133107
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[email protected]
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Contact person for scientific queries
Name
133108
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Bryce Hastings
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Address
133108
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Les Mills International, 363 West Erie Street, Chicago, Illinois 60654
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Country
133108
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United States of America
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Phone
133108
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+1 773 255 3336
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Fax
133108
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Email
133108
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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