None listed
Conditions
Brief summary
The study aims to determine if exercise during significant weight loss as a result of a very low calorie diet influences cardio-metabolic risk factors to a greater extent than current standard practice and in doing so enhances patient adherence to a healthier lifestyle. Design and Methods 120 pre menopausal females, aged 18 and 50 years will be recruited for this study. Participants will be randomly allocated into either a 12 month exercise intervention (EXER) group or control (standard care ER) group. People will be excluded from the study if they have: (i) muscle or joint problems that limit physical activity, (ii) have type 1 diabetes, (iii) are pregnant or planning to become pregnant in the next 12 months, or are breast feeding, (iv) Unstable cardiac condition. The exercise group will train with an accredited exercise physiologist (AEP) and/or Masters of clinical exercise physiology student three days per week for 6 weeks and slowly reduce in face to face contact over the 12-month period. During the 12-month period participants will increase home based exercise developed in conjunction with the AEP and/or Masters student. The AEP will remain in regular contact with the participants through the use of telecommunication, email and social networking in addition to the supervised training that progressively reduces to fortnightly consultations in the second 6 month period. The intention of this model is to help the participant move from high reliance and contact with the AEP to self-management of their own exercise program, while still receiving ongoing support of the AEP. Training will consist of a variety of aerobic and resistance exercise with a 5 minute warm up followed by 50 minutes of exercise and 5 minutes of cool down at either: Deakin University Burwood campus, BakerIDI, or community based facility. At baseline and at 3, 6 and 12 months, after recruitment participants will undergo the following assessments at Deakin University Burwood and Baker IDI: Dual-energy X-ray absorptiometry (DXA) body composition; fasting blood collection to measure cholesterol, glucose, insulin, markers of bone formation and breakdown; muscle strength tests, aerobic capacity (fitness) test; sit to stand out of a chair, blood pressure over 24 hours, physical activity recordings using an accelerometor, recordings of nerve activity of the leg and testing of the elasticity of the blood vessels using non-invasive methods; and questionnaires to assess quality of life, exercise self efficacy, and rating of musculoskeletal pain.
Interventions
There will be two groups of participants: energy restriction alone (ER) or energy restriction plus exercise intervention groups (EXER). EXER will follow the same energy restricted standard care clinical approach as ER. The exercise intervention will consist of a 12 month exercise program of small group and individual physical activity sessions (all supervised) and also home-based physical activity. The supervised exercise training will consist of the following:
3 x 1 hour supervised exercise ses
There will be two groups of participants: energy restriction alone (ER) or energy restriction plus exercise intervention groups (EXER). EXER will follow the same energy restricted standard care clinical approach as ER. The exercise intervention will consist of a 12 month exercise program of small group and individual physical activity sessions (all supervised) and also home-based physical activity. The supervised exercise training will consist of the following: 3 x 1 hour supervised exercise sessions per week (weeks 1-6) 2 x 1 hour supervised exercise session per week (weeks 7-12) 1 x 1 hour supervised exercise session per week (weeks 13-26) 2 x 1 hour supervised exercise sessions per month (weeks 27-52) The exercise training will consist of both moderate intensity aerobic and strength training using a variety of machines and free weights. Home-based physical activity will be developed around each participant’s access to equipment and facilities. It will predominantly include aerobic based exercise early in the program. Later in the program during the period of infrequent supervised sessions the home based program will be aerobic and resistance exercise as most suited to each participant. It is expected that the participants continue to progress the volume of the home based program during the 12 month intervention. Progression will lead to a minimum target of 200 minutes per week (including supervised sessions). Daily exercise will be encouraged.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Females aged 18-50 years. Premenopausal
Exclusion criteria
Type 1 diabetes, unstable cardiac condition, Significant musculoskeletal complaint that prevents participation in any exercise, Pregnant or planning pregnancy in the 12 months following surgery.
Outcome results
None listed