title: Train High Eat Low for Osteoarthritis study (THE LO study): protocol for a randomized controlled trial.
abstract: BACKGROUND
  Osteoarthritis (OA) is one of the most prevalent chronic conditions among older adults, with the medial tibio-femoral joint being most frequently affected. The knee adduction moment is recognized as a surrogate measure of the medial tibio-femoral compartment joint load and therefore represents a valid intervention target. This article provides the rationale and methodology for THE LO study (Train High, Eat Low for Osteoarthritis), which is a randomized controlled trial that is investigating the effects of a unique, targeted lifestyle intervention in overweight/obese adults with symptomatic medial knee OA.
  
  
  OBJECTIVE
  Compared to a control group given only lifestyle advice, do the effects of the following interventions result in significant reductions in the knee adduction moment: (1) gait retraining; and (2) combined intervention (which involves a combination of three interventions: (a) gait retraining, (b) high-intensity progressive resistance training, and (c) high-protein/low-glycaemic-index energy-restricted diet)? It is hypothesized that the combined intervention group will be superior to the isolated interventions of the high-protein/low-glycaemic-index diet group and the progressive resistance training group. Finally, it is hypothesized that the combined intervention will result in a greater range of improvements in secondary outcomes, including: muscle strength, functional status, body composition, metabolic profile, and psychological wellbeing, compared to any of the isolated interventions or control group.
  
  
  METHODS
  Single-blinded, randomized controlled trial adhering to the CONSORT guidelines on conduct and reporting of non-pharmacological clinical trials.
  
  
  METHODS
  One hundred and twenty-five community-dwelling people are being recruited. Inclusion criteria include: medial knee OA, low physical activity levels, no current resistance training, body mass index ≥ 25kg/m(2) and age ≥ 40 years.
  The participants are stratified by sex and body mass index, and randomized into one of five groups: (1) gait retraining; (2) progressive resistance training; (3) high-protein/low-glycaemic-index energy-restricted diet (25 to 30% of energy from protein, 45% of energy from carbohydrates, < 30% of energy from fat, and glycaemic index diet value < 50); (4) a combination of these three active interventions; or (5) a lifestyle-advice control group. All participants receive weekly telephone checks for health status, adverse events and optimisation of compliance.
  
  
  METHODS
  Outcomes are measured at baseline, 6 and 12 months. The primary outcome is the peak knee adduction moment during the early stance phase of gait. The secondary outcome measures are both structural (radiological), with longitudinal reduction in medial minimal joint space width at 12 months, and clinical, including: change in body mass index; joint pain, stiffness and function; body composition; muscle strength; physical performance/mobility; nutritional intake; habitual physical activity and sedentary behaviour; sleep quality; psychological wellbeing and quality of life.
  
  
  CONCLUSIONS
  THE LO study will provide the first direct comparison of the long-term benefits of gait retraining, progressive resistance training and a high-protein/low-glycaemic-index energy-restricted diet, separately and in combination, on joint load, radiographic progression, symptoms, and associated co-morbidities in overweight/obese adults with OA of the knee.
authors: Exercise, Health and Performance Faculty Research Group & Charles Perkins Centre.
authors: Yareni
authors: Y
authors: Guerrero
authors: Exercise, Health and Performance Faculty Research Group & Charles Perkins Centre.
authors: Najeebullah
authors: N
authors: Soomro
authors: Exercise, Health and Performance Faculty Research Group & Charles Perkins Centre.
authors: Guy
authors: G
authors: Wilson
authors: Exercise, Health and Performance Faculty Research Group & Charles Perkins Centre.
authors: Yian
authors: Y
authors: Dam
authors: Exercise, Health and Performance Faculty Research Group & Charles Perkins Centre.
authors: Jacinda
authors: J
authors: Meiklejohn
authors: Exercise, Health and Performance Faculty Research Group & Charles Perkins Centre.
authors: Kylie
authors: K
authors: Simpson
authors: Exercise, Health and Performance Faculty Research Group & Charles Perkins Centre.
authors: Richard
authors: R
authors: Smith
authors: School of Molecular Bioscience and Charles Perkins Centre.
authors: Jennie
authors: J
authors: Brand-Miller
authors: Discipline of Physiotherapy, Arthritis and Musculoskeletal Research Group, Faculty of Health Sciences, The University of Sydney, Lidcombe.
authors: Milena
authors: M
authors: Simic
authors: Exercise, Health and Performance Faculty Research Group & Charles Perkins Centre; School of Molecular Bioscience and Charles Perkins Centre.
authors: Helen
authors: H
authors: O'Connor
authors: Exercise, Health and Performance Faculty Research Group & Charles Perkins Centre.
authors: Yorgi
authors: Y
authors: Mavros
authors: School of Medicine, University of Western Sydney (Campbelltown Campus), Campbelltown.
authors: Nasim
authors: N
authors: Foroughi
authors: Department of Rheumatology, Concord Repatriation Hospital, Concord.
authors: Tat
authors: T
authors: Poon
authors: Exercise, Health and Performance Faculty Research Group & Charles Perkins Centre.
authors: Kate
authors: K
authors: Bradshaw
authors: Northern Clinical School, Royal North Shore Hospital, The University of Sydney.
authors: Lyn
authors: L
authors: March
authors: Exercise, Health and Performance Faculty Research Group & Charles Perkins Centre; Department of Kinesiology, Faculty of Kinesiology and Rehabilitation Sciences, KU Leuven, Leuven, Belgium.
authors: Benedicte
authors: B
authors: Vanwanseele
authors: Institute of Anatomy, Paracelsus Medical University Salzburg & Nuremberg, Salzburg, Austria.
authors: Felix
authors: F
authors: Eckstein
authors: Discipline of Physiotherapy, Arthritis and Musculoskeletal Research Group, Faculty of Health Sciences, The University of Sydney, Lidcombe.
authors: Marlene
authors: M
authors: Fransen
authors: Universidade Federal de São Carlos, Departamento de Educação Física e Motricidade Humana, São Carlos, São Paulo, Brasil.
authors: Joao
authors: J
authors: Bergamasco
authors: Department of Rheumatology, Concord Repatriation Hospital, Concord.
authors: Ananthila
authors: A
authors: Anandacoomarasamy
authors: Exercise, Health and Performance Faculty Research Group & Charles Perkins Centre; Sydney Medical School, The University of Sydney, Camperdown, Australia; Hebrew SeniorLife Boston, and Jean Mayer USDA Human Nutrition Research Centre on Aging at Tufts University, Boston, USA.
authors: Maria Fiatarone
authors: MF
authors: Singh
mesh_terms: D000328:Adult; D000368:Aged; D002985:Clinical Protocols; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D005684:Gait; D006801:Humans; D007719:Knee Joint / Q000503:physiopathology; D008019:Life Style; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications / Q000628:therapy*; D020370:Osteoarthritis, Knee / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D010147:Pain Measurement; D011788:Quality of Life; D012107:Research Design; D016037:Single-Blind Method; D016896:Treatment Outcome