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Trial registered on ANZCTR


Registration number
ACTRN12619001297112
Ethics application status
Approved
Date submitted
27/08/2019
Date registered
20/09/2019
Date last updated
20/09/2019
Date data sharing statement initially provided
20/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise for hip osteoarthritis symptoms: the PHOENIX study
Scientific title
Exercise for hip osteoarthritis related pain and physical dysfunction: the PHOENIX study
Secondary ID [1] 298231 0
Nil known
Universal Trial Number (UTN)
U1111-1235-2431
Trial acronym
PHOENIX (People with Hip Osteoarthritis - EffectiveNess of Informed eXercise RCT)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip osteoarthritis 312830 0
Condition category
Condition code
Musculoskeletal 311328 311328 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 312675 312675 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomised controlled trial will compare two exercise interventions for management of hip osteoarthritis.

Both interventions will include 9 individual in clinic physiotherapist consultations (first consultation up to 1 hours and up to 30 minutes thereafter) and a home exercise program over the same 12 week period. Physiotherapy consultations are expected to occur at weeks 1,2,3,4,5,6,8,10 and 12. The purpose of the physiotherapy consultations are to deliver, monitor and progress participants through the interventions described below.

The two interventions are:
i) lower-limb muscle strengthening exercises
ii) lower-limb muscle strengthening (exactly as in intervention described above) and aerobic physical activity

i) The lower-limb muscle strengthening exercise program will included up to 6 exercises including a hip extensor exercise, a hip flexor exercise, a hip adductor exercise, a hip abductor exercise and 1-2 functional exercises (i.e. squat). The intensity for the strengthening exercise will aim to be “very hard” (i.e. 7 out of 10) on the modified Borg Rating of Perceived Exertion CR-10 scale for muscle strengthening. Strengthening exercises will take approximately 20 minutes to complete and participants will be asked to complete these 3 times per week at home.

ii) In addition to the strengthening program exactly as described above, participants will receive an aerobic physical activity program. Physiotherapists will facilitate participants to build up to engage in 150 minutes of moderate intensity aerobic physical activity per week. Physiotherapist will guide participants to self-manage their aerobic physical activity at an intensity equivalent to at least “somewhat” (i.e. 13 out of 20) on the Borg Rating of Perceived exercise and corresponding heart rate on their wearable activity monitor. Types of aerobic physical activity will be negotiated between the physiotherapist and participant, and may include any type of activity, acceptable to, and feasible for the participant. Participants will be encouraged to incorporate aerobic physical activity into their daily lives and guided to gradually increase their aerobic physical activity at moderate intensity by at least 10 minutes block per week over the 3-month supervised intervention period until 150 minutes of at least moderate intensity exercise per week, in bouts of at least 10 minutes.

Participants will be provided with all the related exercise equipment including: elastic bands, ankle-cuff weights, exercise mat and a wearable activity monitor. The initial 3 months will be followed by a continuation of the exercise intervention independently for a further 6 months.
Intervention code [1] 314475 0
Treatment: Other
Comparator / control treatment
We are comparing the effects of the two exercise groups described under "intervention".
Control group
Active

Outcomes
Primary outcome [1] 320060 0
Severity of Overall Hip Pain

Scored on an 11-point numerical rating scale for average overall hip pain in the last week. Ranges from 0 to 10; where 0=no pain and 10=worst pain possible.
Timepoint [1] 320060 0
Baseline, 3 and 9 months after randomisation
Primary outcome [2] 320660 0
Physical Function Subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

Scored using 17 questions regarding hip function in the last 48 hours, using Likert response options ranging from None to Extreme. Total score ranges from 0 to 68; higher scores indicate worse function.
Timepoint [2] 320660 0
Baseline, 3 and 9 months after randomisation
Secondary outcome [1] 370399 0
Global Improvement in hip pain

Scored using a 7-point global rating of change Likert scale with response options ranging from “much worse” to “much better” when compared to baseline. Participants indicating they are “moderately better” or “much better” will be classified as improved. All other respondents will be classified as not improved.
Timepoint [1] 370399 0
3 and 9 months after randomisation
Secondary outcome [2] 370400 0
Quality of Life (AQOL-6D)

Scored using the 20-item Assessment of Quality of Life II Instrument (AQOL) 6D version, which covers the topics of Independent Living, Relationships, Mental Health, Coping, Pain and Senses to come up with one overall value representing quality of life. Total score ranges from -0.04 to 1.00; higher scores indicate better quality of life.
Timepoint [2] 370400 0
Baseline, 3 and 9 months after randomisation
Secondary outcome [3] 372397 0
Overall hip pain during walking

Scored on an 11-point numerical rating scale (NRS) for average hip pain during walking in the last week. Scores range from 0 to 10; where 0=no pain and 10=worst pain possible.
Timepoint [3] 372397 0
Baseline, 3 and 9 months after randomisation
Secondary outcome [4] 372404 0
Hip Extensor Strength

Maximum voluntary isometric strength will be assessed using dynamometer with participants in supine. Mean torque over 2 maximal efforts will be recorded (Nm/kg). Higher score indicates greater strength.
Timepoint [4] 372404 0
Baseline and 3 months after randomisation
Secondary outcome [5] 372405 0
Knee Extensor Strength

Maximum voluntary isometric strength will be assessed using an isokinetic dynamometer with the knee at 60 degree knee flexion. Peak torque over 3 maximal efforts will be recorded (Nm/kg). Higher score indicates greater strength.
Timepoint [5] 372405 0
Baseline and 3 months after randomisation
Secondary outcome [6] 372406 0
Hip Abductor Strength

Maximum voluntary isometric strength will be assessed using dynamometer with participants in supine. Mean torque over 2 maximal efforts lasting 3 seconds will be recorded (Nm/kg). Higher score indicates greater strength.
Timepoint [6] 372406 0
Baseline and 3 months after randomisation
Secondary outcome [7] 372407 0
30 Second Chair Sit to Stand Test

Number of chair stands completed in 30 secs will be recorded. Higher score indicates better function.
Timepoint [7] 372407 0
Baseline and 3 months after randomisation
Secondary outcome [8] 372408 0
40 Meter Fast Pace Walk Test

Time to taken to walk 4 x 10 m quickly but safely (m/s). Higher speed indicates better function.
Timepoint [8] 372408 0
Baseline and 3 months after randomisation
Secondary outcome [9] 372409 0
6-Step Stair Climb Test

Time take to ascend and descend a flight of 6 stairs as quickly as possible. Use of handrail is permitted if needed. Shorter time indicates better function.
Timepoint [9] 372409 0
Baseline and 3 months after randomisation
Secondary outcome [10] 372410 0
Cardiorespiratory Fitness

This will be assessed as submaximal oxygen consumption using a graded incremental exercise protocol on a cycle ergometer. Participants will start at 1W/kg and increase 0.5W/body mass (kg). Test will terminate when respiratory quotient is >1.00, or equal to ~75% of max heart rate. Oxygen consumption in ml per min relative to body mass will reported. Higher values indicate greater cardiorespiratory fitness.
Timepoint [10] 372410 0
Baseline and 3 months after randomisation
Secondary outcome [11] 374258 0
Pain Subcale of the WOMAC

Pain will be assessed using the 5-item pain subscale of the WOMAC respectively, with Likert response options ranging None to Extreme; higher scores indicate worse pain.
Timepoint [11] 374258 0
Baseline, 3 and 9 months after randomisation
Secondary outcome [12] 374259 0
Patient-specific functional scale

Participants will be asked to indicate up to five activities that performance was limited in the previous week and rate these on a 11-point NRS ranging from 0-10, where 0 indicates ‘unable to perform’ and 10 indicates ‘able to perform at prior level’. Total score will be sum of the activity divided by number of activities, higher scores indicating better function.
Timepoint [12] 374259 0
Baseline, 3 months and 9 months after randomisation
Secondary outcome [13] 374829 0
Global Improvement in physical function

Scored using a 7-point global rating of change Likert scale with response options ranging from “much worse” to “much better” when compared to baseline. Participants indicating they are “moderately better” or “much better” will be classified as improved. All other respondents will be classified as not improved.
Timepoint [13] 374829 0
3 and 9 months after randomisation
Secondary outcome [14] 374830 0
Global Improvement in overall change

Scored using a 7-point global rating of change Likert scale with response options ranging from “much worse” to “much better” when compared to baseline. Participants indicating they are “moderately better” or “much better” will be classified as improved. All other respondents will be classified as not improved.
Timepoint [14] 374830 0
3 and 9 months after randomisation
Secondary outcome [15] 374831 0
Stiffness Subcale of the WOMAC

Movement stiffness will be assessed using the 2-item stiffness subscale of the WOMAC, with Likert response options ranging None to Extreme; higher scores indicate worse stiffness
Timepoint [15] 374831 0
Baseline, 3 and 9 months after randomisation

Eligibility
Key inclusion criteria
Participants aged 50 years or older will be eligible for the study if they meet the following inclusion criteria:
i. American College of Rheumatology criteria for clinical diagnosis for hip osteoarthritis that is – hip pain in combination with either 1) hip internal rotation greater than or equal to 15 degrees, pain present on internal rotation of the hip, morning stiffness of the hip less than or equal to 60 minutes; or 2) hip internal rotation less than 15 degrees and hip flexion equal to or less than 115 degrees
ii. Report history of hip pain for longer than 3 months;
iii. Report hip pain on most days of the past month;
iv. Report an average overall pain score of at least 4 on an 11-point numeric rating scale over the previous week;
v. Pass the American College of Sports Medicine Exercise Pre-participation Health Screening Questionnaire; or if anyone who fails this pre-exercise questionnaire, general practitioner clearance must be obtained to participate in this study (see Phoenix Exercise Clearance GP letter)
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Unable or unwilling to comply with study protocol;
ii. Inability to speak English;
iii. On waiting list or planning back/lower limb surgery in the next 12 months;
iv. Previous hip replacement in the affected hip;
v. Any hip surgery in the past 6 months;
vi. Currently taking corticosteroids or have done so in the past 3 months;
vii. Any hip injections in the past 3 months or planned hip injections in next 9 months;
viii. Any other joint or muscle problem, such as back, other hip, knees, ankles or feet, which is worse than hip pain on affected side
ix. Participating in strengthening exercises at least three times per week and/or engaging in 150 minutes of moderate aerobic physical activity per week within past 6 months;
x. Performed exercise prescribed by health professional specifically for the hip or lower back in the past 6 months;
xi. Hip pain symptoms associated with extra-articular or lumbar pathology
xii. Self-reported inflammatory arthritis;
xiii. Any neurological condition affecting lower limb and ability to exercise safely;
xiv. Any unstable or uncontrolled cardiovascular condition;
xv. Pregnancy or planned pregnancy.

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)
A researcher not involved in recruitment, enrolment or collection of outcome measures, will allocate participants to a group. This researcher will access the randomisation schedule which will be concealed in a password protected database (REDCap)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be prepared by the biostatistician (permuted block sizes 6 to 12) stratified according to therapist (to control for therapist variation). The schedule will be stored on a password-protected website (REDCap) maintained by a researcher not involved in either participant recruitment or administration of primary/secondary outcome measures.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Primary endpoints of the trial are between-group differences in change in average overall hip pain intensity and change in physical function (Western Ontario and McMaster Universities Osteoarthritis Index) at 3 months. In OA trials, the minimum clinically important difference is a change in pain of 1.8 units (out of 10) and change physical function of 6 units (out of 68). Based on our recently completed RCT in hip OA, we assume a between-participant standard deviation of 2.2 for pain and 13 units for physical function and a baseline to follow-up correlation of 0.46 for pain and 0.40 for physical function. To achieve 90% power and 5% significance level we require 83 participants per group. Allowing for a 15% loss to follow-up rate (informed by previous hip OA trials), we aim to randomise a total of 196 participants.

A biostatistician will analyse the data in a blinded manner. Main comparative analyses between-group will be performed using intention-to-treat. Multiple imputation will be used to account for missing data if >5% of data are missing. For the primary hypothesis, difference in mean change in pain and function (baseline minus follow-up) will be compared between groups using linear regression models adjusting for baseline values, with random effects to account for clustering by therapist. Similar analyses will be conducted for continuous secondary outcomes. Perceived ratings of change will be compared using a logistic regression model with random effect for therapist. A sensitivity analysis will estimate treatment effects assuming full adherence, using a two-stage least squares approach. Effect of patient characteristics on outcomes will be explored by including relevant terms in the models. Standard diagnostic plots will verify model assumptions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 27152 0
3010 - University Of Melbourne

Funding & Sponsors
Funding source category [1] 302769 0
Government body
Name [1] 302769 0
National Health and Medical Research Council
Address [1] 302769 0
GPO Box 1412
Canberra ACT 2601
Country [1] 302769 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
School of Health Sciences
Level 7, Alan Gilbert Building
University of Melbourne VIC 3010
Country
Australia
Secondary sponsor category [1] 302830 0
None
Name [1] 302830 0
Address [1] 302830 0
Country [1] 302830 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303366 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 303366 0
Research Ethics & Integrity
The University of Melbourne
Level 1, 21 Bedford St,
North Melbourne VIC 3051
Ethics committee country [1] 303366 0
Australia
Date submitted for ethics approval [1] 303366 0
29/04/2019
Approval date [1] 303366 0
07/06/2019
Ethics approval number [1] 303366 0
1953795.2

Summary
Brief summary
Hip osteoarthritis is major public health problem with significant personal, social and economic burden. Exercise is central to self-management., but little is known what type of exercise is best. Our primary aim is to evaluate whether people with hip osteoarthritis respond differently to two types of exercise interventions i) lower-limb muscle strengthening and ii) lower limb muscle strengthening with aerobic physical activity.

People with hip osteoarthritis will be randomly allocated into one of two different 9-month home exercise programs. Over the first 12 weeks participant will attend 9 in clinic physiotherapist appointments. The physiotherapist will prescribe a home exercise program following the exercise protocol assigned to the participant. Primary outcomes are overall hip pain and physical function measured at 12 weeks.

The findings of this study will help determine which of the two exercise program are best for people with hip osteoarthritis and will guide clinicians in providing appropriate evidence-based advice for patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93422 0
Dr Michelle Hall
Address 93422 0
Level 7, Alan Gilbert Building
161 Barry Street
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
School of Health Sciences
University of Melbourne VIC 3010
Country 93422 0
Australia
Phone 93422 0
+61 3 8344 0556
Fax 93422 0
Email 93422 0
halm@unimelb.edu.au
Contact person for public queries
Name 93423 0
Ms Gabby Knox
Address 93423 0
Level 7, Alan Gilbert Building
161 Barry Street
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
School of Health Sciences
University of Melbourne VIC 3010
Country 93423 0
Australia
Phone 93423 0
+61 3 8344 0556
Fax 93423 0
Email 93423 0
gabby.knox@unimelb.edu.au
Contact person for scientific queries
Name 93424 0
Dr Michelle Hall
Address 93424 0
Level 7, Alan Gilbert Building
161 Barry Street
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
School of Health Sciences
University of Melbourne VIC 3010
Country 93424 0
Australia
Phone 93424 0
+61 3 8344 0556
Fax 93424 0
Email 93424 0
halm@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have not planned to share individual participant data at this stage.
What supporting documents are/will be available?
No other documents available
Summary results
No Results