Exploring the Short-Term Effect of Bariatric Surgery on Muscle Structure And Function; Followed By A Feasibility Assessment Of Exercise Intervention Post Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Assessment of percentage of patients who were compliant with the intervention arm of the study. To be guided by FitBit monitor use.
研究概览
简要总结
The purpose of this project is to assess the effects of bariatric surgery on muscle structure and function as well as investigating the feasibility of undertaking an exercise intervention post-surgery.
详细描述
A single-centre feasibility research programme based at the Royal Derby Hospital centre of the University of Nottingham. This is an exploratory and feasibility study. Muscle structure and function of 12 patients will be assessed before bariatric surgery and at 6 weeks, and then 10 weeks, after surgery. After 6 weeks, participants will be randomised into two groups. Group 1 will undergo a 4 week Resistance Exercise Training (RET). Group 2 will undergo standard care procedure. The total duration of programme we are aiming for is 13-14 weeks prior to bariatric surgery and exercise intervention for 4 weeks after bariatric surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese adults (BMI greater than or equal to 35 kg/m2)
- •Age range 18-70 years old
- •Scheduled for RYGB surgery or sleeve gastrectomy surgery.
- •Ability to give informed consent
排除标准
- •Patients who are not fit or not suitable for RYGB or Sleeve Gastrectomy as per Tier 4 Bariatric Surgery MDT.
- •For those high-risk patients who are fast tracked to surgery, we will exclude patients with a NYHA >3 or 4 heart failure status and those with end stage renal failure.
- •BMI greater than or equal to 60
研究组 & 干预措施
Group 1 Resistance Exercise Therapy Feasibility
One group who have been randomised to receive 4 weeks of Resistance Exercise Therapy to explore the feasibility of introducing such a programme in the bariatric population.
干预措施: Resistance Exercise Therapy (Other)
Group 2 Standard Care
This group have been randomised to receive standard care post surgery.
结局指标
主要结局
Assessment of percentage of patients who were compliant with the intervention arm of the study. To be guided by FitBit monitor use.
时间窗: Total duration of study per participant is expected to be 13 to 14 weeks
This assessment will be measured as percentage of patients who met compliance targets with the intervention arm for the study.
Assessment of percentage of patients who were retained throughout the intervention arm of the study
时间窗: Total duration of study per participant is expected to be 13 to 14 weeks
To be measured as percentage.
Assessment of number of patients who were recruited to the study
时间窗: Total duration of study per participant is expected to be 13 to 14 weeks
This assessment will be measured as a simple numeric value
To assess the effects of bariatric surgery on skeletal muscle ultrasound thickness.
时间窗: Total duration of study per participant is expected to be 13 to 14 weeks
This will be assessed using muscle ultrasound and units (mm)
To assess the effects of bariatric surgery on skeletal muscle cross sectional area (cm2)
时间窗: Total duration of study per participant is expected to be 13 to 14 weeks
This will be assessed using muscle ultrasound
次要结局
- Muscle fatigability (maximum voluntary contractions)(Total duration of study per participant is expected to be 13 to 14 weeks, each assessment for this outcome will take place at the in-person study days.)
- Balance using the Timed Up and Go (TUG) test(Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.)
- Skin fold and body circumference measurements(Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.)
- Hand grip strength(Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.)
- Motor control in force tracking(Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.)
- Skeletal muscle architecture (pennation angle)(Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.)
- Quality of life measurements using IPAQ questionnaire(Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.)
- Fasting glucose(Total duration of study per participant is expected to be 13 to 14 weeks, there will be bloods taken on each in-person study day. Plan is for 3 of these days, screening bloods will be reviewed from the NHS interface.)
- Skeletal muscle architecture (fibre length)(Total duration of study per participant is expected to be 13 to 14 weeks, ultrasounds will be performed at each in-person study day. performed on each in-person study day)
- Balance in Gait and Motion testing(Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.)
- Lean body mass using BIA and D3 creatine(Total duration of study per participant is expected to be 13 to 14 weeks, each participant will be provided with the resources to facilitate these assessments at their in-person study days, urine collections will be returned later..)
- Predicted maximum oxygen consumption (VO2 max) in step box test(Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.)
- insulin resistance (HOMA-IR)(Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.)
- Quality of life measurements using SF-36 questionnaire(Total duration of study per participant is expected to be 13 to 14 weeks, these assessments will be performed at each in-person study day.)