Article Text
Abstract
Objectives To determine if physiotherapists can deliver a clinically effective very low energy diet (VLED) supplementary to exercise in people with knee osteoarthritis (OA) and overweight or obesity.
Methods 88 participants with knee OA and body mass index (BMI) >27 kg/m2 were randomised to either intervention (n=42: VLED including two daily meal replacement products supplementary to control) or control (n=46: exercise). Both interventions were delivered by unblinded physiotherapists via six videoconference sessions over 6 months. The primary outcome was the percentage change in body weight at 6 months, measured by a blinded assessor. Secondary outcomes included BMI, waist circumference, waist-to-hip ratio, self-reported measures of pain, function, satisfaction and perceived global change, and physical performance tests.
Results The intervention group lost a mean (SD) of 8.1% (5.2) body weight compared with 1.0% (3.2) in the control group (mean (95% CI) between-group difference 7.2% (95% CI 5.1 to 9.3), p<0.001), with significantly lower BMI and waist circumference compared with control group at follow-up. 76% of participants in the intervention group achieved ≥5% body weight loss and 37% acheived ≥10%, compared with 12% and 0%, respectively, in the control group. More participants in the intervention group (27/38 (71.1%)) reported global knee improvement than in the control group (20/42 (47.6%)) (p=0.02). There were no between-group differences in any other secondary outcomes. No serious adverse events were reported.
Conclusion A VLED delivered by physiotherapists achieved clinically relevant weight loss and was safe for people with knee OA who were overweight or obese. The results have potential implications for future service models of care for OA and obesity.
Trial registration number NIH, US National Library of Medicine, Clinicaltrials.gov NCT04733053 (1 February 2021).
- Osteoarthritis
- Weight loss
- Randomized Controlled Trial
- Physical Therapy
Data availability statement
Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. The datasets used and/or analysed during the current trial will be made available from the corresponding author on reasonable request.
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Data availability statement
Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. The datasets used and/or analysed during the current trial will be made available from the corresponding author on reasonable request.
Footnotes
X @HinmanRana
Contributors KLB and KA obtained funding for the trial; KA, KLB and RSH designed the trial with input from SJ, PS, JGQ, JPr, MAH, NEF and EG. SJ, KA and KLB developed the training modules, and SJ conducted the mock patient training, audited the practice patient training and provided training feedback to physiotherapists. SJ and JP coordinated the trial. PL, ADS and KLB prepared the statistical analysis plan blinded, and PL performed statistical analyses with guidance from ADS. KA and KLB wrote the draft of this paper and all authors edited and approved the final version. KB is the guarantor and accepts full responsibility for the finished work and/or the conduct of the study, had access to the data and controlled the decision to publish.
Funding National Health and Medical Research Council (NHMRC) Program Grant #1091302 and Investigator Grant (#1174431), Physiotherapy Research Fund Project Grant PG18-004 and University of Melbourne Early Career Researcher Grant 2019. RSH is supported by a National Health & Medical Research Council Senior Research Fellowship (#1154217). KLB is supported by a National Health and Medical Research Council Investigator Grant (#1174431). NEF is supported by a National Health and Medical Research Council Investigator Grant (#2018182).
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.
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