Exercise and weight loss for hip osteoarthritis: a clinical trial

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.