None listed
Conditions
Brief summary
There is consistent evidence showing that very low energy diets (VLEDs) reduce weight amongst patients with obstructive sleep apnoea (OSA) and comorbid obesity. This method of obesity reduction although effective, may be accompanied by an associated change in body composition in patients with OSA, notably concurrent loss of muscle mass. Excessive loss of muscle mass may be undesirable because this tissue is responsible for the majority of resting metabolic rate, regulation of core body temperature, preservation of skeletal integrity, and maintenance of function and quality of life as the body ages. Our study has a pragmatic design and patients will attend a commercially available high intensity functional exercise training programme. To date, there have been no randomised trials of naturalistic exercise training that is practical and may promote exercise adherence in patients with OSA. We aim to show that this model of training can protect against the loss of muscle mass, as delivered through a programme that can be readily translated to real world settings. Furthermore, we will confirm whether there is an additive benefit of this model of training in addition to a VLED in reducing OSA severity as compared to dietary induced weight loss only.
Interventions
High intensity functional exercise intervention program for weight loss in overweight and obese patients with obstructive sleep apnoea not treated with continuous positive airway pressure (CPAP). This is a two arm pilot randomised controlled trial. All participants (n=30) will undergo a commercially available very low energy diet (VLED). Participants will be randomised to either participating in the exercise intervention (n=15) or diet alone (n=15). The exercise intervention is a 3 month face-to-face stepped program of increasing high intensity functional exercise at a commercially available exercise facility (F45 gyms). Participants will undertake a combination of high intensity (as measured by activity trackers with heart rate monitoring and the Borg RPE scale) resistance and aerobic-based group classes which last a duration of 45 minutes each. Exercise sessions involve functional motions including but not limited to kicking, punching, rowing, running, pulling, pushing, squatting, lifting, jumping, tossing and twisting. Sessions involve a rotating program of exercises completed at stations. Exercises are performed for approximately 30-45 seconds with a 15 second rest interval between stations. Classes are conducted by trained exercise professionals employed by the exercise company. The level of training of these exercise professionals range from a tertiary diploma through to a University degree. The class schedule is as follows: week 1-2: 2x resistance based classes per week weeks 3-6: 2x resistance based classes, 1x aerobic based class per week weeks 7-8: 2x resistance based classes, 2x aerobic based classes per week weeks 9-12: 2x resistance based classes, 3x aerobic based classes per week The exercise program will be adapted to meet the specific of each participant and appropriate adjustments will be made. Adherence to the exercise program will be assessed through reports from participants and by the data obtained through activity trackers provided to patients. The diet component consists of a 3 month period where participants replace meals with a commercially available very low energy diet product for example bars, soups or shakes from brands such as Tony Ferguson, OptiFast, OptiSlim, KickStart or Formulite. Participants will be provided with the VLED product and will be required to prepare each serving according to manufacturer’s instructions. Individual protein requirements and the number of replacements required for each participant will be determined by a trained physician, dietitian or exercise physiologist as per the participant’s adjusted body weight. Protein needs are 1gm/kg of Adjusted Body Weight. Adjusted body weight is calculated using the following: ((Actual Body Weight - Ideal Body Weight) x 0.5) + IBW = Adjusted Body Weight Actual Body Weight = Current Weight Ideal Body Weight = Weight at BMI 25 The diet schedule is typically as follows: weeks 1-8: 3 x meal replacement bars, soups or shakes daily weeks 9-10: 2 x meal replacement bars, soups or shakes daily and 1 x standard meal weeks 11-12: 1 x meal replacement bar, soup or shake daily and 2 x standard meals Participants are encouraged to purchase, prepare and consume an extra 2 cups of vegetables and a teaspoon of oil daily whilst completing the initial 8 weeks of the diet. Patients who reach their desired body weight prior to completion of the 8 week period will be assessed whether to progress to a maintenance meal plan earlier than the 12 week timepoint. 24 hour food recall assessments will determine the rate of compliance of participants.
Sponsors
Study design
Eligibility
Inclusion criteria
Men aged 18-55 years of age BMI >27kg/m² or waist circumference >102cm if European, >90cm if non-European Willing and medically able to participate in a supervised very low energy diet and exercise programme for a 12-week period Obstructive Sleep Apnoea diagnosed on a PSG with AHI >15 events/hr Willing and able to complete all assessments outlined in the participant information sheet
Exclusion criteria
Any known contraindications to very low energy diet or exercise o History of or current presence of eating disorders - Unstable Cardiovascular Disease including: o aortic aneurysm o Severe left ventricular dysfunction/congestive heart failure o Severe aortic stenosis o Unstable ischemic heart disease including angina o Endocarditis o Pericarditis (acute) - Irreversible respiratory disease that causes exercise limitation - Rapidly progressive or terminal illness - Severe psychosis or behavioural disturbance or cognitive impairment - OSA consistently treated with continuous positive airway pressure or mandibular advancement splint - Severe OSA that in the Physician’s opinion, requires immediate treatment. - Insulin-Dependent Diabetes Mellitus - Uncontrolled Type II Diabetes Mellitus