None listed
Conditions
Brief summary
This study aims to compare the effectiveness of two scalable interventions (Exercise; Exercise plus Weight Management) to each other, and to an information-only control group, for overweight/obese people with clinically diagnosed knee osteoarthritis (OA) on the primary outcomes of knee pain and function at 6 months. The Exercise group will receive six consultations with a physiotherapist via videoconferencing over six months, including prescription of an exercise and physical activity plan, education and advice about common management strategies, and provision of educational material. The Exercise plus Weight Management group will receive six physiotherapist consultations in addition to six consultations with a dietitian via videoconferencing over six months, which will include a weight management program. We will recruit 415 Medibank Private members from around Australia who have clinical knee OA and are overweight/obese. The primary outcomes are self-reported pain and function. A range of secondary outcomes will also be assessed including weight, physical activity, health-related quality of life, global rating of change, mood, satisfaction with care, appointments with orthopaedic surgeons, knee surgery procedures and willingness to undergo surgery. Outcomes will be measured at baseline, 6 months and 12 months. A health economic analysis will be conducted alongside the trial.
Interventions
This trial has two intervention groups:
The "Exercise" intervention consists of education about osteoarthritis, advice on treatment options and decision support, structured exercise and physical activity plans, behaviour change support, and other self-management strategies including pain coping skills training activities. Participants will have 6 consultations with a physiotherapist via videoconferencing (approximately weeks 1, 3, 7, 11, 16, and 21 of the 24-week intervention), which will be ap
This trial has two intervention groups: The "Exercise" intervention consists of education about osteoarthritis, advice on treatment options and decision support, structured exercise and physical activity plans, behaviour change support, and other self-management strategies including pain coping skills training activities. Participants will have 6 consultations with a physiotherapist via videoconferencing (approximately weeks 1, 3, 7, 11, 16, and 21 of the 24-week intervention), which will be approximately 45 minutes in duration (initial consultation) and 20 minutes in duration (subsequent consultations). During consultations, the physiotherapist will formulate appropriate goals and a tailored management plan involving a structured strengthening exercise program (e.g. quadriceps/hamstring/calf strengthening exercises) and physical activity plan (e.g. daily step goals) and provide verbal education and advice about practical self-management strategies. Management plans will be tailored according to exercise/knee pain history, functional ability, and personal goals. Custom-developed educational resources (e.g. information sheets) about osteoarthritis, treatment options, exercise and physical activity, and other self-management strategies will be provided to the participant in hard copy (mailed in a resource folder) and on a study website. Participants will have access to the study website from enrolment to the completion of their 12-month follow-up questionnaire. Participants will also receive exercise resistance bands, exercise/activity log sheets and a Fitbit to allow them to track and monitor their physical activity goals. Intervention fidelity will be assessed by audit of recordings of a sample of consultations throughout the intervention. The "Exercise plus weight management" intervention aims to provide active weight management support in addition to the services as per the "Exercise" group intervention described above. It includes all of the elements described for the Exercise intervention and, in addition, includes access to 6 dietitian consultations via videoconferencing over 6 months, plus a weight management program, plus educational materials to support weight loss. The weight management program includes a weight loss phase (using a very low energy/ketogenic diet where 2 meals per day are replaced with Optifast products, with the aim being to lose >10% of body weight), a transition phase (moving to one meal replacement per day) and a weight maintenance phase (healthy eating with no meal replacements). The duration of the weight loss phase will be individual and will depend on the amount of weight needed to lose and adherence to the program. The duration of the transition phase will be approximately 2 weeks, and the weight maintenance phase is intended to be life-long. Dietitians will formulate a weight management plan with their participant during their initial consultation (approximately 45 minutes duration) and will review progress in follow-up consultations (approximately 20 minutes duration). The timing of all 6 dietitian consultations will be negotiated between the dietitian and participant, depending on individual needs and progress. Participants will initially be mailed a sample of meal replacement products (shakes, soups and bars of different flavours) so that they can determine their preference for flavour/type of product. Each of the meal replacement products are approximately 840-990 kilojoules (201-235 calories) per serving. Participants will also be mailed a resource folder containing information about the weight management program and additional resources to help support weight loss (e.g. information sheets about identifying/changing eating habits). Most weight management resources will be custom-developed specifically for the study, however some readily available resources will also be included (e.g. fact sheets from the Baker Heart and Diabetes Institute and the Australian Healthy Food Guide). These resources will also be provided on the study website, which participants will have access to from enrolment to completion of their 12-month follow-up questionnaire. Intervention fidelity will be assessed by audit of recordings of a sample of consultations throughout the intervention.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Our selection criteria are consistent with a clinical diagnosis of osteoarthritis from both the National Institute for Health and Care Excellence (NICE) and the Australian Clinical Care Standard for reaching diagnosis of knee osteoarthritis). Specific inclusion criteria are: 1. Aged between 45 and 80 years 2. Reports activity-related knee joint pain 3. Reports morning knee stiffness less than or equal to 30 minutes; 4. History of knee pain on most days for 3 months or more; 5. Overall average knee pain in past week self-rated as 4 or more out of 10 on an 11-point numeric rating scale; 6. Body mass index (BMI) greater than or equal to 28 kg/m2 and < 41 kg/m2; 7. Member of Medibank Private with a level of cover that includes arthroplasty surgery; 8. Able to give informed consent and to participate fully in the interventions and assessment procedures; 9. Willing to follow advice for self-management, participate in exercise/physical activity and/or participate in the weight loss program if part of their treatment program; and 10. Have the ability to regularly weigh themselves (e.g. have access to a set of bathroom scales).
Exclusion criteria
1. Booked for knee surgery on either knee; 2. Have had all eligible knee joints replaced (i.e. bilateral replacements or unilateral replacement with non-operated knee pain < 4 out of 10); 3. Recent knee surgery within the past 6 months; 4. Unable to speak English or unable read English; 5. Self-reported diagnosis of rheumatoid arthritis or other inflammatory arthritis; 6. Other medical condition or upcoming medical procedures that in the opinion of the research staff and/or investigators would preclude participation; 7. Unable to use/access telephone and internet; 8. For those identified as at risk from the pre-exercise and falls screening, GP does not give clearance; 9. Used low-calorie meal replacement products (e.g. Optifast /Optislim) for weight loss in previous 6 months; 10. Currently, or during the past 6 months, undertaking regular strengthening exercise for the knee or; 11. Unable to undertake Very Low Energy/ketogenic diet for medical reasons including: a. Self-reported diagnosis of Type 1 diabetes b. Self-reported Type 2 diabetes requiring insulin or other medication apart from metformin c. Self-reported warfarin use d. Stroke or cardiac event in previous 6 months e. Unstable heart condition f. Fluid intake restriction.
Outcome results
None listed