Effects of adding a diet intervention to exercise on hip osteoarthritis pain: protocol for the ECHO randomized controlled trial

• Published in: BMC musculoskeletal disorders 2022-03, Vol.23 (1), p.215-14, Article 215
• Main Authors: Hall, Michelle, Hinman, Rana S, Knox, Gabrielle, Spiers, Libby, Sumithran, Priya, Murphy, Nicholas J, McManus, Fiona, Lamb, Karen E, Cicuittini, Flavia, Hunter, David J, Messier, Stephen P, Bennell, Kim L
• Format: Article
• Language: English
• Subjects: Arthralgia; Care and treatment; Diet therapy; Exercise; Exercise therapy; Exercise Therapy - methods; Hip; Humans; Ketogenic diet; Osteoarthritis; Osteoarthritis, Hip - complications; Osteoarthritis, Hip - diagnostic imaging; Osteoarthritis, Hip - therapy; Osteoarthritis, Knee - therapy; Pain - complications; Pain Measurement - methods; Physical activity; Quality of Life; Randomized Controlled Trials as Topic; Study Protocol; Testing; Treatment Outcome; Weight management
• ISSN: 1471-2474; 1471-2474
• DOI: 10.1186/s12891-022-05128-9

Hip osteoarthritis (OA) is a leading cause of musculoskeletal pain. Exercise is a core recommended treatment. Despite some clinical guidelines also recommending weight loss for hip OA, there is no evidence from randomised controlled trials (RCT) to substantiate these recommendations. This superiority, 2-group, parallel RCT will compare a combined diet and exercise program to an exercise only program, over 6 months. One hundred people with symptomatic and radiographic hip OA will be recruited from the community. Following baseline assessment, participants will be randomly allocated to either, i) diet and exercise or; ii) exercise only. Participants in the diet and exercise group will have six consultations with a dietitian and five consultations with a physiotherapist via videoconferencing over 6 months. The exercise only group will have five consultations with a physiotherapist via videoconferencing over 6 months. The exercise program for both groups will include prescription of strengthening exercise and a physical activity plan, advice about OA management and additional educational resources. The diet intervention includes prescription of a ketogenic very low-calorie diet with meal replacements and educational resources to support weight loss and healthy eating. Primary outcome is self-reported hip pain via an 11-point numeric rating scale (0 = 'no pain' and 10 = 'worst pain possible') at 6 months. Secondary outcomes include self-reported body weight (at 0, 6 and 12 months) and body mass index (at 0, 6 and 12 months), visceral fat (measured using dual energy x-ray absorptiometry at 0 and 6 months), pain, physical function, quality of life (all measured using subscales of the Hip Osteoarthritis Outcome Scale at 0, 6 and 12 months), and change in pain and physical activity (measured using 7-point global rating of change Likert scale at 6 and 12 months). Additional measures include adherence, adverse events and cost-effectiveness. This study will determine whether a diet intervention in addition to exercise provides greater hip pain-relief, compared to exercise alone. Findings will assist clinicians in providing evidence-based advice regarding the effect of a dietary intervention on hip OA pain. ClinicalTrials.gov . Identifier: NCT04825483 . Registered 31st March 2021.