Train High Eat Low for Osteoarthritis: THE LO Study

Not Applicable

Recruiting

• Conditions: Osteoarthritis; Overweight/Obese; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Diet and Nutrition - Obesity; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12612000501842
• Lead Sponsor: niversity of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

The following inclusion criteria enable the volunteer to participate in the THE LO Study:
- Primary osteoarthritis of at least one knee
- BMI >27.5 kg/m2
- Aged 40 years or more

Criteria used to make OA diagnosis:
- Knee pain
- +ve at least 1 of 3:
- Age > 50 years
- Stiffness < 30 minutes
- Crepitus
- +ve Osteophytes
- +ve Xray diagnosis (or other previous scans)

Exclusion Criteria

The following conditions permanently exclude the subject from participation in the THE LO STUDY:
- Unstable aortic aneurysm
- Rapidly progressive or terminal illness
- Severe left ventricular dysfunction/end stage congestive heart failure
- Severe aortic stenosis
- Secondary osteoarthritis (traumatic or post-surgical), rheumatic disease, gouty or septic arthritis, Paget's disease, pseudogout, major congenital abnormalities, hemachromatosis, Wilson's disease and other rare forms of arthritis)
- Previous or anticipated (within 6-12 months) joint replacement operation
- Severe psychosis or behavioural disturbance or cognitive impairment
- Surgery to any structure (cartilage, bone, tendons, ligaments, muscle) in or around the knee joint

The following conditions require medical intervention or re-evaluation prior to participation in THE LO Study:
- Abnormal resting ECG
- Angina (unstable)
- Arrhythmias or heart block (uncontrolled)
- Breathing problem or motion disorder
- Cardiac surgery (within last 6 months)
- Cataract extraction (within last month)
- CHF (uncontrolled)
- Cognitive impairment (mild-moderate)
- COPD / CAL (uncontrolled)
- Diabetes (uncontrolled, eg. HbA1c > 10%)
- Deep venous thrombosis (acute)
- Endocarditis
- Fracture (recent or delayed union)
- Haemorrhoids (severe)
- Hernia (unrepaired or symptomatic; abdominal or inguinal)
- Hypertension (uncontrolled; arterial or pulmonary)
- Knee joint injury within the past 6 months
- Knee Injections (e.g. Corticosteroids – cortisone); no more than 2 in the last 5 years, and only one in the last 6 months.
- Myocardial infarction (acute; within last 6 months)
- Neurological disease (rapidly progressive or unstable)
- Pericarditis (acute)
- Pulmonary embolism or infarction (acute)
- Retinopathy, recently treated, unstable
- Severe functional limitation (unable to walk unaided by a person)

Study & Design

• Study Type: Interventional
• Study Design: Not specified