Effectiveness of Aerobic and Resisted exercise training in post-bariatric subjects on aerobic capacity, body composition, physiological and psychological parameters: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- VO2R, Waist Circumference, 1RM, BMI, Blood Pressure, HbA1C, Becks Depression Inventory, Gastro-intestinal Symptom Rating Scale.
研究概览
简要总结
Obesity is a disease characterized by excess adiposity that is a source of extensive morbidity and mortality due to various weight related complications. It results from low physical activity and sedentary behaviour. BMI ≥ 30kg/m2 defines an individual to be obese. Although, obesity itself is a morbid disease, it also predisposes an obese individual to various pathologies which are Diabetes Mellitus (type 2), Hypertension, Cardiovascular disorders, Respiratory disorders, early degenerative changes of various joints of the body, depression, and many more. Though there are various benefits of bariatric surgery, up till what duration the benefits are lasting is unclear. Also, whether aerobic and resisted exercise plays a vital role in post bariatric patients or not is unclear. Thus, this study aims to identify effectiveness of aerobic exercise and strength training for post bariatric surgery patients on different parameters of body, that is, Aerobic capacity, Body consumption, physiological and psychological aspects.
Random allocation of 120 subjects would be done to control group(n=60) (group A) and experimental group(n=60) (group B). All the parameters will be recorded of all subjects of both groups before undergoing bariatric surgery. Post-surgery after 1-month similar procedure will be done.
Exercise intervention will be initiated for group-B as only after permission from bariatric surgeon. Before beginning the protocol, subject’s;
Aerobic capacity will be assessed using 6MWT.
Strength will be assessed using 1RM
BMI and Waist Circumference will be assessed using measure tape and stadiometer
Skin fold thickness will be assessed using skin fold calliper
HBA1c measurement will be recorded (every 3 months)
Scales – BDI & GSRS
Pre-intervention session and post intervention subject’s vitals will be recorded to ensure optimum recovery after intervention. The intervention protocol will be of minimum 8 weeks and 3days/week. The recording of all parameters will be taken intermittently within intervals of 4 weeks.
After completion of intervention protocol, recording of all the parameters will be continuously taken for 2 months or till deconditioning effects are observed (whichever is first), with 1month interval between recordings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •BMI more than 30 2)Medically stable, undergoing bariatric surgery.
排除标准
- •Moderate to severe illness of any system 2)High risk patient for cardiovascular and neurological system 3)Musculoskeletal pathology 4)Inability to perform the functional tests and interventions.
结局指标
主要结局
VO2R, Waist Circumference, 1RM, BMI, Blood Pressure, HbA1C, Becks Depression Inventory, Gastro-intestinal Symptom Rating Scale.
时间窗: Every 4weeks Interval till subjects show deconditioning effect.
次要结局
- 1)Six-minute walk distance(2)Skinfold thickness)