Effects of Physical Activity Counseling After Bariatric Surgery on the Level of Activity and Anthropometric Measures
试验速览
- 阶段
- 不适用
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- MET's of Self-reported physical activity
研究概览
简要总结
This study will examine whether providing physical activity counseling and guidance to patients post bariatric surgery, along with long-term personal follow-up for six months after the surgery, may increase the level of physical activity, and it's effect on anthropometric and functional measures.
详细描述
Bariatric surgery is considered to be most effective in treating morbid obesity for patients with BMI≥40 or BMI≥35 with comorbidity for obesity.
postoperative weight loss following any type of bariatric surgery is largely dependent on the extent to which patients can make and sustain changes in their eating habits and activity level. Adopting physical activity habits can help to optimize outcomes after bariatric surgery, such as contributing to the rate of weight loss after the surgery and maintain lean body mass.
In order to successfully implement a behavioral change regarding the adaptation of healthy lifestyle habits in obese patients, it is vital to promote physical activity counseling after the surgery, and to find an effective intervention that can support habitual physical activity.
The aim of this trial is to examine the effect physical activity counseling after bariatric surgery on the amount and intensity of activity performed, quality of life, anthropometric and functional measures during the first year after surgery.
Up to eighty Participants will be recruited for the trial, and will be randomly assigned to one of the two study arms (Control, Intervention). The intervention group will receive physical activity counseling and guidelines for the following six months after the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ≥ 40 kg/m2 or 35 kg/m2 with comorbidities
- •18 to 50 Years old
- •Patient is suitable according to the pre-operative evaluation standards to undergo Bariatric surgery
- •Speaks Hebrew/Arabic fluently
排除标准
- •Cognitive decline or severe psychiatric or mental illness
- •Patient undergone bariatric surgery in the past
- •Pregnancy or Breastfeeding
- •Orthopedic disease that limits training and mobility (such as severe arthritis, injury or fractures)
- •Heart disease with a risk to exercise (heart failure, severe aortic stenosis, uncontrolled arrhythmia, and acute coronary syndrome)
- •Moderate /severe lung disease or COPD with FEV1 / FVC <70% on a pulmonary function test
结局指标
主要结局
MET's of Self-reported physical activity
时间窗: 1 year post-surgery
Physical activity score in MET's from self-reported International Physical Activity Questionnaire (IPAQ-sf). Score will be categorized to low, moderate and high intensity level of physical activity.
Average daily Step count
时间窗: 1 year post-surgery
Average daily step count of the last 7 days before each visit
次要结局
- Changes in BMI(Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery)
- Changes in Handgrip strength test (Kg)(Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery)
- sit to stand test(Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery)
- Changes in Health-related Quality of life assessed by SF-36 Questionnaire(Change from Baseline at up to 26 weeks (end of the intervention phase))
- changes in Self-efficacy assessed by (SSE)- Self-efficacy for physical exercise scale(Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery)
- Changes in Muscle Mass(Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery)
- six min walk test(Change from Baseline at up to 26 weeks (end of the intervention phase))
- Change in glucose and HbA1c levels(Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery)
- Change in total cholesterol, HDL and LDL levels(Change from Baseline at up to 26 weeks (end of the intervention phase) and 1 year post-surgery)
研究者
Ram Elazary
Head Bariatric surgeon Hadassah Ein Kerem
Hadassah Medical Organization