Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000461796
Ethics application status
Approved
Date submitted
25/02/2022
Date registered
24/03/2022
Date last updated
30/08/2023
Date data sharing statement initially provided
24/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise and weight loss for hip osteoarthritis: a clinical trial
Scientific title
Effectiveness of a telehealth-delivered clinician-supported exercise and weight loss program (Better Hip) for hip osteoarthritis: a randomised controlled trial
Secondary ID [1] 306284 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip osteoarthritis 325044 0
Obesity 325670 0
Condition category
Condition code
Musculoskeletal 322475 322475 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 322476 322476 0 0
Physiotherapy
Diet and Nutrition 322477 322477 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the intervention group (Better Hip program) will have six individual consultations with a physiotherapist over six months, using the telehealth platform Coviu. The consultations will cover education about osteoarthritis (OA) and discussion of non-drug treatment options, prescription of an individualised home-based strengthening program (to be performed independently three times per week) and physical activity plan, behaviour change support, and facilitation of other self-management strategies. The home-based strengthening program will comprise 5-7 strengthening exercises targeting muscle groups around the hip, and will be prescribed to be performed independently at home 3 times a week commencing at the time of the first physiotherapist consultation and continuing for the duration of the 6-month intervention. Example exercises which may be prescribed as part of the intervention include but are not limited to: prone hip extension against gravity; bridging with progressions including single leg bridging; squats; sit-to-stand; step-ups; seated knee extension; standing/side-lying hip abduction; crab walks; crook-lying hip flexion; and standing/side-lying hip adduction. The intensity for the strengthening exercises will aim for 5-7 out of ten (hard to very hard) on the modified Borg Rating of Perceived Exertion CR-10 scale for strength training. Participants will be instructed that each exercise should be performed slowly and in a controlled manner. Progression will be guided in accordance with American College of Sports Medicine guidelines by adjustments to repetitions, direction, and speed of movements; increasing resistance; and/or changing stance surface.

The physical activity plan will comprise a daily step goal that aims to increase on current activity levels, and that lists individual strategies relevant to the individual that will assist them in meeting that daily step goal. These will be individually prescribed and monitored by the physiotherapist in collaboration with the participant, and monitored by the participant by use of the activity tracker which will be provided to them.

The first consultation with the physiotherapist will be 45 minutes in duration, and subsequent consultations 30 minutes. Participants will receive exercise resistance bands, exercise/activity log sheets and an activity tracker to allow them to track and monitor their physical activity goals, as well as educational resources on OA and exercise designed specifically for the study. Physiotherapists will also advise the participants to download the My Exercise Messages app, which was developed by a team including CIs Bennell and Hinman and is freely available in Apple App Store and Google Play. My Exercise Messages was created to help support people with OA stick to their weekly exercise goals, including exercise prescribed by health professionals. The app sends prompts at least once per week reminding participants to complete their exercise sessions to facilitate adherence to the exercise intervention.

Participants randomised to the intervention group who have a BMI >27 kg/m2 , are aged < 80 years and do not have any conditions that would exclude them from taking part, are also offered six individual consultations with a dietitian over six months to undertake a weight loss program, also over the telehealth platform Coviu. The first consultation with the dietitian will be 45 minutes in duration, and subsequent consultations 30 minutes. The six consultations are recommended to occur in weeks 2, 4, 6, 9-12, 14-17 and 19-23 of the 6-month intervention period, but the precise timing will be negotiated between each participant and their dietitian. This program includes a ketogenic Very Low Energy Diet (VLED) for up to 16 weeks (commenced after the first consultation with the dietitian) followed by transition to a healthy eating plan for weight maintenance. As part of the intervention, participants will be provided with formulated meal replacements of their choice of bars, shakes or soups in a variety of flavours (two per day for a maximum of 16 weeks) to support weight loss, and will be encouraged to lose around 10% of body weight, as this is associated with clinically important improvements in OA pain and function. On the diet, one prepared meal (generally dinner) comprises protein (e.g. white or red meat, fish or seafood, eggs, or tofu) and non-starchy vegetables/salad. A small amount (i.e. 1 tablespoon) of fat/oil is also recommended for this meal to stimulate gallbladder contraction. In total, the diet contains approximately 800 calories (3280 kilojoules) per day. After 16 weeks (or earlier if the participant has reached their weight loss target), participants will be guided to progress to one meal replacement per day for a further 4 weeks (supplied as part of the intervention), to aid the gradual transition to a weight maintenance phase. During the consultations, appropriate weight loss goals will be agreed and a tailored management plan for losing weight developed. Conversations based on motivational interviewing principles and techniques will be used to develop readiness to change (motivation) and confidence to self-manage. Ongoing education, information and advice are key components of the intervention to optimally support weight loss.

Additional bespoke resources for those undertaking weight management will include:
• A plastic “portion plate” to help manage meal portion sizes and stick to the ketogenic VLED when preparing meals;
• Another plastic “portion plate” to help manage meal portion sizes when transitioning to the healthy eating diet for weight maintenance;
• A set of digital weight scales for those who don’t have access to some already;
• Educational information about the VLED;
• Ketogenic recipe book;
• Food list pocket guide;
• Workbook with information and templates to track weight, a food diary, tips to find a support person, identifying food triggers, planning for “at risk” situations, overcoming barriers, changing thought patterns, and monitoring hunger levels.

Participant adherence to the intervention will be monitored by reporting number of consultations with physiotherapist +/- dietitian (if eligible), duration of consultations with physiotherapists +/- dietitian, and by self-report of adherence to strengthening exercise program, physical activity plan +/- weight management plan at 6 and 12 months.

The ketogenic VLED will not be used in participants with the following conditions:
i) Type 1 diabetes
ii) Type 2 diabetes requiring insulin or other medication apart from metformin
iii) Warfarin use
iv) Stroke or cardiac event in the previous 6 months
v) Unstable arrhythmia
vi) Fluid intake restriction
vii) Have sought medical intervention for constipation in the past 12 months
Participants with the above conditions, or who are aged over 80 years will be excluded from the dietary intervention, as the trial doesn’t involve direct and ongoing medical supervision. Participants must also be willing to undertake the VLED using the meal replacement products to be eligible for the dietitian consultations.


Intervention code [1] 322713 0
Rehabilitation
Intervention code [2] 322715 0
Lifestyle
Intervention code [3] 322716 0
Behaviour
Comparator / control treatment
Participants in the control group will be provided with web-based information about hip OA and its management via a custom website.
Control group
Active

Outcomes
Primary outcome [1] 330264 0
Self-reported severity of hip pain while walking, scored on an 11-point numeric rating scale (NRS)
Timepoint [1] 330264 0
Baseline, 6 months (primary timepoint) and 12 months post randomisation

Tertiary timepoint: participants will also be contacted at two-years post randomisation for collection of primary and secondary outcomes via an online survey. These results will be reported separately to the main trial results and will occur after analysis of the main trial data and unblinding of the data set.
Primary outcome [2] 330265 0
Self-reported physical function assessed by Western Ontario & McMaster Osteoarthritis Index (WOMAC) physical function sub-scale.
Timepoint [2] 330265 0
Baseline, 6 months (primary timepoint) and 12 months post randomisation

Tertiary timepoint: participants will also be contacted at two-years post randomisation for collection of primary and secondary outcomes via an online survey. These results will be reported separately to the main trial results and will occur after analysis of the main trial data and unblinding of data set.
Secondary outcome [1] 405506 0
Pain subscale of the Hip dysfunction and Osteoarthritis Outcome Score (HOOS)
Timepoint [1] 405506 0
Baseline, 6 and 12 months after randomisation

Tertiary timepoint: participants will also be contacted at two-years post randomisation for collection of primary and secondary outcomes via an online survey. These results will be reported separately to the main trial results and will occur after analysis of the main trial data and unblinding of data set.
Secondary outcome [2] 405507 0
Quality of life subscale of the Hip dysfunction and Osteoarthritis Outcome Score (HOOS)
Timepoint [2] 405507 0
Baseline, 6 and 12 months after randomisation

Tertiary timepoint: participants will also be contacted at two-years post randomisation for collection of primary and secondary outcomes via an online survey. These results will be reported separately to the main trial results and will occur after analysis of the main trial data and unblinding of data set.
Secondary outcome [3] 405508 0
Function, sports and recreational activities subscale of the Hip dysfunction and Osteoarthritis Outcome Score (HOOS)
Timepoint [3] 405508 0
Baseline, 6 and 12 months after randomisation

Tertiary timepoint: participants will also be contacted at two-years post randomisation for collection of primary and secondary outcomes via an online survey. These results will be reported separately to the main trial results and will occur after analysis of the main trial data and unblinding of data set.
Secondary outcome [4] 405509 0
Self-reported weight
Timepoint [4] 405509 0
Baseline, 6 and 12 months after randomisation

Tertiary timepoint: participants will also be contacted at two-years post randomisation for collection of primary and secondary outcomes via an online survey. These results will be reported separately to the main trial results and will occur after analysis of the main trial data and unblinding of data set.
Secondary outcome [5] 405512 0
Assessment of Quality of Life Instrument (8-dimension)
Timepoint [5] 405512 0
Baseline, 6 and 12 months after randomisation

Tertiary timepoint: participants will also be contacted at two-years post randomisation for collection of primary and secondary outcomes via an online survey. These results will be reported separately to the main trial results and will occur after analysis of the main trial data and unblinding of data set.
Secondary outcome [6] 405513 0
Physical Activity Scale for the Elderly.
Timepoint [6] 405513 0
Baseline, 6 and 12 months after randomisation

Tertiary timepoint: participants will also be contacted at two-years post randomisation for collection of primary and secondary outcomes via an online survey. These results will be reported separately to the main trial results and will occur after analysis of the main trial data and unblinding of data set.
Secondary outcome [7] 405514 0
Global rating of overall change in hip, 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.
Timepoint [7] 405514 0
6 and 12 months after randomisation

Tertiary timepoint: participants will also be contacted at two-years post randomisation for collection of primary and secondary outcomes via an online survey. These results will be reported separately to the main trial results and will occur after analysis of the main trial data and unblinding of data set.
Secondary outcome [8] 405515 0
Self-reported hip replacement procedures on study hip
Timepoint [8] 405515 0
6 and 12 months after randomisation

Tertiary timepoint: participants will also be contacted at two-years post randomisation for collection of primary and secondary outcomes via an online survey. These results will be reported separately to the main trial results and will occur after analysis of the main trial data and unblinding of data set.
Secondary outcome [9] 405516 0
Self-reported willingness to have hip replacement surgery in the near future, scored using a 5-point Likert scale with anchors “definitely not willing” and “definitely willing”.
Timepoint [9] 405516 0
Baseline, 6 and 12 months after randomisation

Tertiary timepoint: participants will also be contacted at two-years post randomisation for collection of primary and secondary outcomes via an online survey. These results will be reported separately to the main trial results and will occur after analysis of the main trial data and unblinding of data set.
Secondary outcome [10] 405517 0
Proportion of participants using oral pain medications for hip pain. Participants will self-report the use of any pain medication, defined as one or more of analgesics (paracetamol combinations) and/or oral non-steroidal anti-inflammatory drugs and/or oral glucocorticoids and/or oral opioids taken at least once a week in the prior month for their hip pain.
Timepoint [10] 405517 0
Baseline, 6 and 12 months after randomisation

Tertiary timepoint: participants will also be contacted at two-years post randomisation for collection of primary and secondary outcomes via an online survey. These results will be reported separately to the main trial results and will occur after analysis of the main trial data and unblinding of data set.

Eligibility
Key inclusion criteria
Participants will be eligible for the study if they meet the following inclusion criteria:
i) National Institute for Health and Care Excellence clinical criteria for OA
i. age 45 years or older;
ii. activity-related hip joint pain;
iii. no morning hip stiffness, or morning hip stiffness less than 30 mins
ii) report hip pain on most days for 3 months or more;
iii) report overall average hip pain while walking in the past week more than or equal to 4 on an 11-point numerical rating scale (NRS; 0 = no pain, 10 = worst pain possible);
iv) access to a computer/laptop/tablet with internet connection and a webcam for videoconferencing consultations;
v) own a smartphone (for pairing with activity tracker);
vi) willing and able to participate in video consultations for physiotherapy and dietitian appointments;
vii) member of Medibank private with a level of cover that includes arthroplasty surgery; and
viii) able to give informed consent and to participate in the interventions and assessment procedures.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) inability to speak or read English;
ii) on waiting list for/planning knee/hip surgery in next 6 months;
iii) previous arthroplasty on affected hip;
iv) recent hip surgery (past 6 months);
v) doing regular leg strengthening exercise (at least once per week) each week for the past 6 weeks;
vi) weight loss of >2 kg over the previous 3 months;
vii) current active weight loss intervention
viii) planned bariatric surgery in next 6 months;
ix) pregnancy or planned pregnancy;
x) self-reported inflammatory arthritis (e.g. rheumatoid arthritis);
xi) any neurological condition affecting lower limbs;
xii) any unstable/uncontrolled cardiovascular condition;
xiii) history of fall/s (past 12 months) and no GP clearance to participate;
xiv) house-bound due to immobility and no GP clearance to participate; and/or
xv) fail the Exercise and Sports Science Australia stage 1 pre-exercise screening questions and no GP clearance to participate.


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)
The person who will determine if a potential participant is eligible for inclusion in the trial will be unaware, when this decision is made, to which group the participant will be allocated. The randomisation schedule will be concealed in a password protected computer database. A member of the research team will maintain and access the schedule and reveal allocation to the Trial Coordinator as each participant requires randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be prepared by the biostatistician (permuted random block sizes) stratified by participant BMI (>27 kg/m2 and less than or equal to 27 kg/m2).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Two-arm, parallel-design, superiority pragmatic randomised controlled trial (RCT).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size Estimation: We aim to detect the minimal clinically important difference (MCID) over 6 months on the co-primary outcomes of change in pain (NRS) and physical function (WOMAC). The MCID in OA trials is a 1.8-unit pain change and 6-unit function change. The sample size calculation accounts for potential clustering by physiotherapists in the Better Hip arm. Based on our previous research, we assume a conservative between-participant standard deviation of 2 pain units and 11 function units, correlations between baseline and 6-month scores of 0.25 for pain and 0.4 for function, an intra-cluster correlation of 0.05 and 5 physiotherapists treating participants. With these parameters, we need 90 participants per arm to achieve 80% power to detect the MCID in function at a 0.025 significance level (due to two co-primary outcomes). This gives >99% power to detect the MCID in pain. Allowing for 15% attrition, we will recruit 106 people per arm (in total n=212).

Statistical Analysis Plan: We will use intention-to-treat analyses. A Statistical Analysis Plan will be written and published on the CHESM website prior to data analysis commencing. The main trial analysis will occur after the collection of all outcomes at the 12 month timepoint. Participants will also be contacted at two-years post randomisation for collection of primary and secondary outcomes via an online survey. These results will be reported separately to the main trial results and will occur after analysis of the main trial data and unblinding of data set.

Main trial analysis (post 12-month timepoint): For co-primary outcomes and other secondary continuous outcomes, mean differences in change over time between groups will be estimated via linear mixed-effects models, with random effects for participants and physiotherapist. Models will be adjusted for baseline outcomes and BMI (>27 kg/m2 and less than or equal to 27 kg/m2). Terms for time and treatment will be included, and their interaction. To aid clinical interpretation, the primary outcomes will also each be dichotomized into those who do and do not achieve the minimal clinically important difference (MCID) in improvement in pain (1.8 NRS units) and function (6 WOMAC units). Counts and percentages of participants achieving the MCID in improvement in pain and function will be reported in each treatment group at 6 and 12 months. For binary outcomes (clinically-relevant improvement, global change, participants using any oral pain medication at least once per week, willingness to have hip replacement surgery), logistic mixed effects models will be fitted adjusted for baseline where able and BMI (>27 kg/m2 and less than or equal to 27 kg/m2) with random effects for participant and physiotherapist, with effects summarised using risk differences and 95% confidence intervals. Analysis of moderation of the treatment effect by pre-specified potential moderators (baseline willingness to have surgery, BMI) on the two co-primary outcomes will be assessed by including interactions between moderators and the treatment group in the regression models.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/06/2022
Actual
7/07/2022
Date of last participant enrolment
Anticipated
28/06/2024
Actual
Date of last data collection
Anticipated
28/06/2026
Actual
Sample size
Target
212
Accrual to date
106
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310632 0
Government body
Name [1] 310632 0
Australian Government Department of Health: Medical Research Future Fund
Country [1] 310632 0
Australia
Funding source category [2] 310634 0
Commercial sector/Industry
Name [2] 310634 0
Medibank Private Limited
Country [2] 310634 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Office of Research, Ethics and Integrity
Research, Innovation & Commercialisation
Level 5, Alan Gilbert Building, 161 Barry Street, Carlton
University of Melbourne VIC 3010
Country
Australia
Secondary sponsor category [1] 311844 0
None
Name [1] 311844 0
Address [1] 311844 0
Country [1] 311844 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310234 0
The University of Melbourne Science, Technology, Engineering, Mathematics and Medicine 2 Human Research Ethics Committee
Ethics committee address [1] 310234 0
Office of Research Ethics and Integrity
Research, Innovation & Commercialisation
Level 5, Alan Gilbert Building, 161 Barry Street, Carlton
The University of Melbourne, Victoria 3010 Australia
Ethics committee country [1] 310234 0
Australia
Date submitted for ethics approval [1] 310234 0
08/12/2021
Approval date [1] 310234 0
23/02/2022
Ethics approval number [1] 310234 0
2022-22498-25615-3

Summary
Brief summary
We are conducting a clinical trial to evaluate the effectiveness of a telehealth-delivered clinician-supported program (Better Hip) which will comprise education, strengthening exercise, physical activity, self management strategies and if needed, dietary intervention for weight loss, for people with hip osteoarthritis. We will evaluate the effectiveness of the Better Hip program on pain and physical function at 6 and 12 months.

The two different treatment groups in this study are:
1. Website (information) group: access to a website with information about hip osteoarthritis and how to manage the condition; or
2. Better Hip group: 6 video consultations with a physiotherapist for information and prescription of an exercise program. Additionally, for those with a BMI > 27 kg/m2 who are aged under 80 years: 6 video consultations with a dietitian for prescription of a dietary weight loss program over 6 months, comprising a ketogenic very low energy diet followed by guidance to transition to healthy eating for weight maintenance.

Primary and secondary outcomes will be collected via online survey at baseline, 6 and 12 months. A further online survey for follow-up of primary and secondary outcomes will be also conducted at 2 years post randomisation. These results will be reported separately to the main trial results and will occur after analysis of the main trial data.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116946 0
Prof Kim Bennell
Address 116946 0
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
Level 7, Alan Gilbert Building, 161 Barry Street
The University of Melbourne VIC 3010
Country 116946 0
Australia
Phone 116946 0
+61 3 8344 4135
Fax 116946 0
Email 116946 0
k.bennell@unimelb.edu.au
Contact person for public queries
Name 116947 0
Ms Bridget Graham
Address 116947 0
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
Level 7, Alan Gilbert Building, 161 Barry Street
The University of Melbourne VIC 3010
Country 116947 0
Australia
Phone 116947 0
+61 3 8344 0061
Fax 116947 0
Email 116947 0
bjgraham@unimelb.edu.au
Contact person for scientific queries
Name 116948 0
Prof Kim Bennell
Address 116948 0
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
Level 7, Alan Gilbert Building, 161 Barry Street
The University of Melbourne VIC 3010
Country 116948 0
Australia
Phone 116948 0
+61 3 8344 4135
Fax 116948 0
Email 116948 0
k.bennell@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


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.