Status:
COMPLETED
Effects of a Physiotherapist-delivered Dietary Weight Loss Program in People with Knee OA Who Have Overweight/obesity
Lead Sponsor:
University of Melbourne
Conditions:
Knee Osteoarthritis
Overweight and Obesity
Eligibility:
All Genders
45-80 years
Phase:
NA
Brief Summary
The aim of this randomized controlled trial is to evaluate the effects of a physiotherapist-delivered dietary weight loss program on clinical outcomes among people with knee osteoarthritis (OA) who ha...
Detailed Description
Clinical guidelines for the management of knee OA recommend exercise as a core treatment for all patients as well as losing weight for those patients who also have overweight/obesity. However, health ...
Eligibility Criteria
Inclusion
- Meet the National Institute for Health and Care Excellence \[47\] clinical criteria for OA: age≥45 years; activity-related knee joint pain; morning knee stiffness ≤ 30 mins
- report history of knee pain ≥ 3 months
- report knee pain on most days of the past month
- report a minimum knee pain score of 4 on an 11-point numeric rating scale during walking over the previous week
- body mass index (BMI) \>27 kg/m2
- those using hypertensive medication must be willing to have their blood pressure checked (this can be self-monitoring, at a pharmacist or at a GP) if they feel light-headed or dizzy at any point during the study
- able to give informed consent and to participate fully in the interventions and assessment procedures
Exclusion
- weight \>150 kgs (due to the added complexities of additional nutritional requirements for individuals above this weight)
- inability to speak English
- on waiting list for/planning knee/hip surgery or bariatric surgery in next 6 months
- arthroplasty on affected knee
- recent knee surgery on affected knee (past 6 months);
- self-reported inflammatory arthritis (e.g. rheumatoid arthritis)
- weight loss of \> 2 kg over the previous 3 months
- already actively trying to lose weight by any of the following mechanisms:using meal replacements for weight loss; being a member of a slimming club (e.g. weight watchers); receiving support from another health care professional for weight loss; using any drugs prescribed to aid in weight loss; using structured meal programs for weight loss such as 'Lite n' Easy'
- unwilling to continue current dietary patterns if randomized to exercise only group
- unable to undertake ketogenic VLCD for medical reasons including self-reported: diagnosis of Type 1 diabetes;Type 2 diabetes requiring insulin or other medication apart from metformin; Warfarin use; stroke or cardiac event in previous 6 months; unstable cardiovascular conditions; fluid intake restrictions; renal (kidney) problems (unless clearance is obtained from a general practitioner (GP), including GP confirmation that estimated glomerular filtration rate \>30 mL/min/1.73m2); any neurological condition affecting lower limbs; vegan dietary requirements due to complexity of delivering a nutritionally complete diet within the ketogenic diet regime
Key Trial Info
Start Date :
October 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04733053
Start Date
October 29 2021
End Date
May 1 2023
Last Update
December 9 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Melbourne
Melbourne, Victoria, Australia, 3010