Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000509662
Ethics application status
Approved
Date submitted
5/05/2014
Date registered
13/05/2014
Date last updated
13/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Can an exercise programme before surgery improve patient outcomes following hip joint replacement for osteoarthritis?
Scientific title
Can prehabilitation improve patient outcomes following hip joint replacement for osteoarthritis?
Secondary ID [1] 284546 0
Nil known
Universal Trial Number (UTN)
U1111-1154-5504
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip joint osteoarthritis 291810 0
Condition category
Condition code
Musculoskeletal 292172 292172 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 292197 292197 0 0
Physiotherapy
Surgery 292199 292199 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be a multi-modal exercise programme adapted from the exercise therapy protocol used in the Management of Osteoarthritis Trial (Australian New Zealand Clinical Trials Registry ACTRN12608000130369). The programme includes lower limb strengthening (with additional specific exercises that target the hip abductor muscles) and stretching exercises, neuromuscular retraining (focusing on balance) and core stability exercises. The exercises will be delivered in a group setting (lead by a physiotherapist), but will be individually-tailored according to the abilities and impairments of each patient.

The group sessions for each cohort of participants in the Intervention Group (6 in each, 12 in total) will be held twice a week in an exercise laboratory at the School of Physiotherapy, University of Otago. These will run over an 8-week period, and each session will last for approximately an hour. A log will be kept of attendance/completion of the prescribed group exercise sessions.

Participants in the intervention group will also receive an individualised home exercise programme to do on the days they do not attend class, which will take approximately 30 minutes. Participants will also be provided with a calendar log to document adherence to the home exercise programme, use of analgesics and any adverse treatment responses (e.g. such as an increase in hip pain). Any adverse reactions occurring during the exercise classes will also be documented. Those assigned to the Control Group will not receive the intervention but continue with usual care.
Intervention code [1] 289307 0
Treatment: Other
Comparator / control treatment
Control Group (n=12), matched to the Intervention Group for sex and where possible age. Participants will continue to receive usual care offered by healthcare providers (which may include visits to general practitioners, physiotherapists, osteopaths) and will not receive the exercise programme (prehabilitation).
Control group
Active

Outcomes
Primary outcome [1] 292053 0
Western Ontario and McMaster Universities Index (WOMAC)
Timepoint [1] 292053 0
Baseline, following completion of 8-week exercise programme, 3 months post-surgery
Secondary outcome [1] 308080 0
30 Second Chair Stand Test. Straight-back chair, approximately 43cm height. Start position: seated in a position that allows feet to be placed flat on the floor, shoulder-width apart, arms crossed over chest. Participant stands completely up so that hips and knees are fully extended then sits completely back down so that bottom fully touches the seat. Repeat for 30 seconds, count complete number of repetitions.
Timepoint [1] 308080 0
Baseline, following completion of 8 week exercise programme, 3 months post-operative
Secondary outcome [2] 308081 0
40 metre fast-paced walk test. Participant directed to walk as quickly but as safely as possible to the cone, walk around and return. Go around the cone at the start, and then repeat the whole thing. Timed, inclusive of turns, using a stop-watch
Timepoint [2] 308081 0
Baseline, following completion of 8 week exercise programme, 3 months post-operative
Secondary outcome [3] 308082 0
Step-up Test (total time taken to step up onto 20cm high step, 3 repetitions). Test both right and left sides, timed using a stop-watch
Timepoint [3] 308082 0
Baseline, following completion of 8 week exercise programme, 3 months post-operative
Secondary outcome [4] 308083 0
Timed Up and Go. Using a standard chair with armrests (approx. 43cm seat height, 65cm arm rest height). Task: Stand up from sitting, walk 3metres to a mark, turn, walk back and sit down. Timed using a stop-watch.
Timepoint [4] 308083 0
Baseline, following completion of 8 week exercise programme, 3 months post-operative
Secondary outcome [5] 308084 0
Hip Abductor Muscle Strength (maximal isometric strength measured using dynamometer)
Timepoint [5] 308084 0
Baseline, following completion of 8 week exercise programme, 3 months post-operative
Secondary outcome [6] 308085 0
Modified Trendelenburg Test
Timepoint [6] 308085 0
Baseline, following completion of 8 week exercise programme, 3 months post-operative
Secondary outcome [7] 308086 0
Hip abductor muscle volume (gluteus medius and gluteus minimus) calculated using volumes obtained from (i) ultrasound scans and (ii) magnetic resonance imaging. The latter measure will only be performed in those participants included in the Intervention Group.
Timepoint [7] 308086 0
Ultrasound: Baseline, following completion of 8-week exercise programme, 3 months post-operative
Magnetic resonance imaging: Baseline, following completion of 8-week exercise programme

Eligibility
Key inclusion criteria
– Meet the clinical criteria for diagnosis of osteoarthritis of the hip (as defined by the American Academy of Rheumatology)
– Unilateral hip pain
– Surgery scheduled for at least 12 weeks after the time of the referral letter
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
– Previous hip joint replacement surgery (either leg) or surgical procedure to other lower limb joints within the past 6 months
– Patients awaiting bilateral hip joint replacement or surgery due to avascular necrosis of the femoral head
– Rheumatoid arthritis
– Inability to comprehend and complete study assessments and commit to undertaking the prehabilitation programme
– Contraindications to MRI such as any metal in the leg or claustrophobia or inability to lie still for 30 minutes

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited from the waiting list of the Orthopaedic Department, Dunedin Public Hospital. After patients reach a priority threshold for hip joint replacement surgery, they are contacted by a Clinical Nurse Specialist (CNS) to commence screening procedures prior to surgery. On successful completion of screening and associated management, patients are then given certainty their surgery will be performed within the next 4-5 months. If the patient agrees the CNS will pass the contact details of the patient onto one of the investigators who will then post out the information sheet. After receiving the information and having had time to consider participation, each patient will be telephoned to ask if she/he would like to take part and meets the eligibility criteria (verbal consent). If she/he agrees, an appointment time will be made whereby written informed consent will be obtained prior to undertaking the functional assessment and imaging. Following surgery, information regarding the surgical approach used for each participant will be provided to the researchers. Participants in the Intervention Group will be recruited first, followed by those in the Control Group (matched for age and sex where possible).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
No randomisation. Participants in the Control Group will be matched where possible for age and sex to those participants in the Intervention Group
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
The outcome assessor will be blinded to progress with the intervention, but will be aware of who is assigned to the Intervention and Control groups due to the design of the study.

Potential participants on the waiting list for hip joint replacement surgery will be consecutively assigned to the Intervention Group if eligible. Participants in the Control Group will be matched where possible for age and sex to those in the Intervention Group, and recruited consecutively from the waiting list.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size: Case control study involving 24 participants (intervention group, n=12; control group, n=12). We have consulted with Mr Andrew Gray, Department of Preventive and Social Medicine, University of Otago regarding study design, sample size and statistical analyses. In determining the sample size of this pilot study we have considered factors such as cost (MRI and ultrasound scanning), and the timely performance of the clinical assessments before and after completing the 8-week
group exercise programme and post-operatively.

One-way repeated measures ANOVA will be used to compare group means for WOMAC, functional test scores and muscle strength at each time point. The estimate of variance will be used to calculate the required sample size for a future RCT. Additionally a student t-test will be used to compare muscle strength of the symptomatic hip with the contralateral side.

Muscle volumes will be compared for each imaging method, pre- and post-intervention as previously described (Flack et al 2012, Surg Radiol Anat 34: 847-55). Volumes obtained from MRI and ultrasound will also be compared using a one-way ANOVA. The reliability of ultrasound will also be established using a subset of patients (n=4) who will come twice (within a few days of each other) for a repeat examination.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/05/2014
Actual
Date of last participant enrolment
Anticipated
30/06/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 6030 0
New Zealand
State/province [1] 6030 0
Otago

Funding & Sponsors
Funding source category [1] 289172 0
Charities/Societies/Foundations
Name [1] 289172 0
Otago Medical Research Foundation (Jack Thomson Arthritis Fund) Inc
Country [1] 289172 0
New Zealand
Primary sponsor type
Individual
Name
Professor Neil Gemmell
Address
Head of Department
Department of Anatomy
University of Otago
PO Box 913
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 287841 0
None
Name [1] 287841 0
Address [1] 287841 0
Country [1] 287841 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290949 0
Health and Disability Ethics Commitees
Ethics committee address [1] 290949 0
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington 6145
Ethics committee country [1] 290949 0
New Zealand
Date submitted for ethics approval [1] 290949 0
Approval date [1] 290949 0
17/04/2014
Ethics approval number [1] 290949 0
14/STH/34

Summary
Brief summary
Osteoarthritis of the hip is a common chronic condition that affects the health and wellbeing of New Zealanders with approximately 7000 people undergoing hip joint replacement per year. This pilot study will examine the feasibility and effectiveness of implementing an exercise programme for patients awaiting hip replacement (prehabilitation). It will also investigate whether ultrasound can be used as a reliable tool to assess hip muscle volume, a modifiable parameter with potential as an outcome measure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48122 0
Dr Stephanie Woodley
Address 48122 0
Department of Anatomy
University of Otago
PO Box 913
Dunedin 9054
Country 48122 0
New Zealand
Phone 48122 0
+64 3 4797353
Fax 48122 0
Email 48122 0
[email protected]
Contact person for public queries
Name 48123 0
Dr Stephanie Woodley
Address 48123 0
Department of Anatomy
University of Otago
PO Box 913
Dunedin 9054
Country 48123 0
New Zealand
Phone 48123 0
+64 3 4797343
Fax 48123 0
Email 48123 0
[email protected]
Contact person for scientific queries
Name 48124 0
Dr Stephanie Woodley
Address 48124 0
Department of Anatomy
University of Otago
PO Box 913
Dunedin 9054
Country 48124 0
New Zealand
Phone 48124 0
+64 3 4797353
Fax 48124 0
Email 48124 0
[email protected]

No information has been provided regarding IPD availability


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
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