The Effect of a Preoperative Exercise Programme on Cardiorespiratory Fitness, Resting Metabolic Rate and Autonomic Control in Patients With Severe Obesity Awaiting Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Fitness (VO2 in ml/kg/min)
研究概览
简要总结
The aim of this project is to understand the impact of a four week preoperative exercise programme on fitness and metabolic rate and weight before surgery.
A multi-site randomised trial sponsored by UCL, recruiting patients awaiting bariatric surgery for obesity at University College London Hospital (UCLH), Whittington Health NHS Trust, or Homerton University Hospital NHS Foundation Trust.
The investigators will measure fitness, metabolic rate, body weight/composition and grip strength in all participants, before and after a four-week supervised physical activity intervention. The investigators will also interview participants about their participation in the study in regard to the planning of future studies.
详细描述
The aim of this project is to understand the impact of a structured personalised 4-week exercise programme on resting fitness and metabolic rate in patients awaiting bariatric surgery for obesity. The hypothesis is that patients awaiting bariatric surgery who undertake a preoperative exercise programme will experience attenuated changes in functional capacity (fitness) and metabolic rate compared with usual care (no exercise programme) along with alterations in autonomic control.
The investigators propose a randomised controlled trial that will recruit 48 patients with obesity scheduled for bariatric surgery at UCLH, Whittington Health NHS Trust, and Homerton University Hospital NHS Foundation Trust. Participants will be randomly assigned to either usual care (exercise advice only) or combination exercise intervention group, during a four-week lead up to surgery, on a 1:1 basis.
Participants randomised to the intervention group will participate in 7 physiologist-led exercise sessions online and also be instructed to complete 7 self-led 30-minute exercise sessions over the four-week intervention period. This equates to a total of 14 exercise sessions across the four-week (28 day) intervention. Additionally, participants will be encouraged to be physically active on as many days as possible, in bouts of 10-minutes or more. The programme is designed to meet the National Physical Activity Guidelines of at least 150 minutes of low-moderate or 75 minutes of vigorous PA per week, or a combination of the two.
The investigators will measure physical fitness, metabolic rate, and how the heart responds to hormonal changes (the sympathetic nervous system) in all participants, before and after the four-week study period. The investigators will also interview participants about their participation in the study in regard to the planning of future studies.
Baseline data collection will occur at least six weeks prior to surgery as detailed below. Both groups will be invited to attend follow-up assessment at 4 weeks where they will undergo the same series of tests. The total duration of participation will be approximately 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults, aged 18 and above.
- •Patients enrolled in the UCLH, Homerton or Whittington Hospitals bariatric surgery program with BMI > 30 kg/m2
- •≤5 % variation in body weight over preceding 3 months.
- •Willing and able to comply with the trial protocol.
- •Willing and able to provide written informed consent
- •Male or Female
排除标准
- •Pregnant or lactating mothers.
- •Weight over 180 kg (due to weight restrictions of equipment used).
- •Current use of betablockade.
- •Concurrent participation in other clinical intervention trial.
- •Clinically significant medical co-morbidities (e.g. uncontrolled hypertension, unstable cardiovascular disease) that could place at risk of an adverse response to exercise.
- •History of atrial fibrillation, unstable angina, acute coronary syndrome, congestive heart failure New York Heart Association class III-IV within the preceding 12 months.
研究组 & 干预措施
Online exercise intervention
A four-week preoperative physical activity intervention, involving a combination of supervised and unsupervised (live or pre-recorded), online exercise sessions. These sessions will be designed to meet the National physical activity guidelines (2020) of at least 150 minutes of low-moderate or 75 minutes of vigorous physical activity per week (or a combination of the two). The intervention will involve moderate intensity activities that aim to increase or maintain muscle strength (resistance training) as well as short bouts of vigorous aerobic exercise, using major muscle groups in the lower and upper body.
干预措施: Online exercise intervention (Behavioral)
Control
Usual care
结局指标
主要结局
Fitness (VO2 in ml/kg/min)
时间窗: 4 weeks
VO2 (at anaerobic threshold (AT) and peak exercise) using gas-analysed cardiopulmonary exercise testing.
次要结局
- Maximal grip strength (kg)(4 weeks)
- Participant satisfaction feedback(4 weeks)
- Autonomic control (heart-rate variability)(4 weeks)
- Body composition (%FM, %FFM)(4 weeks)
- Resting metabolic rate (VO2 in ml/kg/min)(4 weeks)
- Body mass (kg)(4 weeks)
- Physical activity patterns(7 days)