Supervised Exercise Following Bariatric Surgery in the Treatment of Severe/Morbid Obesity: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Percent total weight loss (%TWL) [Biospace Co., InBody 270, USA]
研究概览
简要总结
Severe/morbid obesity is an international public health issue that importantly increases the risk of cardiovascular events and cardiovascular and all-cause mortality. Likewise, severe/morbid obesity increases the risk of illness, reduces quality of life, and raises health-care costs. Bariatric surgery is the election method for the treatment of severe/morbid obesity, resulting in significant weight loss and remission of comorbidities. However, a relatively large proportion of bariatric patients regain weight and continue to be at high risk for cardiovascular disease and premature mortality. A healthy lifestyle following bariatric surgery is essential for optimizing and maintaining weight loss. Observational studies suggest that physical activity following bariatric surgery might be associated with additional weight loss and more effective weigh loss maintenance over time. However, very little experimental evidence exists regarding the effects of supervised exercise on obesity-related outcomes in this specific population.
The aim of the EFIBAR (Ejercicio FÍsico tras cirugía BARiátrica) randomized controlled trial is to determine the effects of a 16-week supervised concurrent (aerobic and strength) exercise intervention program, on weight loss (primary outcome), body composition, cardiometabolic risk, physical fitness and quality of life (secondary outcomes) in patients with severe/morbid obesity following bariatric surgery.
According to the study aims the investigators pursue the following hypothesis: Supervised exercise will result in larger weight loss than control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigators, study coordinators, outcome assessors, and clinical staff will be blinded to the group allocation.
Participants and providers of the exercise delivery will not be blinded to the group allocation.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To comply with local bariatric surgery criteria:
- •Patients with BMI ≥ 40 kg/m2 (or 35 kg/m2 with comorbidities).
- •Acceptable surgical risk (defined by the approval of anesthetist).
- •Obesity maintained for over 5 years.
- •Failure of previous treatments.
- •To sign informed consent for surgical treatment.
- •Not to present contraindications for supervised physical exercise.
- •To reside in the city of Almeria (Spain) or willingness/predisposition to attend the training sessions 3 times a week during 16 weeks
排除标准
- •Severe psychiatric or neurological disorders such as schizophrenia, epilepsia, Alzheimer, Parkinson, personality disorders, eating behaviour disorders, untreated depression or suicidal tendencies.
- •Adrenal or thyroid pathology that might cause obesity.
- •Uncontrolled addiction to alcohol or drugs.
研究组 & 干预措施
Exercise
Usual care PLUS concurrent (aerobic and strength) supervised exercise program of 16 weeks (3 sessions/week, 60 min/session, progressively increasing in volume and intensity). The program will be conducted by certified Exercise Science professionals.
干预措施: Exercise (Other)
Control
Usual care routinely delivered after bariatric surgery, based on national (Spanish) and international recommendations, focused on nutritional status monitoring and diet/physical activity counseling.
结局指标
主要结局
Percent total weight loss (%TWL) [Biospace Co., InBody 270, USA]
时间窗: Changes from baseline to 4-month and 1-year follow-up
%TWL = \[(pre-surgery weight - post-surgery weight) / (pre-surgery weight)\] x 100
次要结局
- Blood markers of glucose metabolism: HOMA-IR(Changes from baseline to 4-month and 1-year follow-up)
- Blood markers of glucose metabolism: insulin(Changes from baseline to 4-month and 1-year follow-up)
- Plasma concentrations of inflammatory markers(Changes from baseline to 4-month and 1-year follow-up)
- Plasma concentrations of liver metabolism enzymes(Changes from baseline to 4-month and 1-year follow-up)
- Cost-utility analysis (CUA)(From baseline to 1-year follow-up)
- Brachial and central blood pressures (mmHg)(Changes from baseline to 4-month and 1-year follow-up)
- Body composition: body fat(Changes from baseline to 4-month and 1-year follow-up)
- Body composition: fat-free mass(Changes from baseline to 4-month and 1-year follow-up)
- Blood markers of glucose metabolism: glucose(Changes from baseline to 4-month and 1-year follow-up)
- Body composition: fat-free mass index(Changes from baseline to 4-month and 1-year follow-up)
- Lipid profile assessed from blood sample(Changes from baseline to 4-month and 1-year follow-up)
- Body composition: central body fat(Changes from baseline to 4-month and 1-year follow-up)
- Arterial stiffness(Changes from baseline to 4-month and 1-year follow-up)
- Health-related physical fitness: upper body muscular strength(Changes from baseline to 4-month and and 1-year follow-up)
- Health-related physical fitness: upper body flexibility(Changes from baseline to 4-month and and 1-year follow-up)
- Health-Related Quality of Life (HRQoL): SF-36(Changes from baseline to 4-month and 1-year follow-up)
- Plasma levels of Vitamin D(Changes from baseline to 4-month and 1-year follow-up)
- Heart rate variability (HRV)(Changes from baseline to 4-month and 1-year follow-up)
- Health-Related Quality of Life (HRQoL): EQ-5D-3L(Changes from baseline to 4-month and 1-year follow-up)
- Symptomatology and function of hip / knee osteoarthritis: Pain(Changes from baseline to 4-month and 1-year follow-up)
- Blood markers of glucose metabolism: glycated hemoglobin HbA1c(Changes from baseline to 4-month and 1-year follow-up)
- Health-related physical fitness: cardiorespiratory fitness(Changes from baseline to 4-month and and 1-year follow-up)
- Health-related physical fitness: lower body muscular strength(Changes from baseline to 4-month and and 1-year follow-up)
- Objectively-measured physical activity(Changes from baseline to 4-month and 1-year follow-up)
- Symptomatology and function of hip / knee osteoarthritis: Stiffness(Changes from baseline to 4-month and 1-year follow-up)
- Symptomatology and function of hip / knee osteoarthritis: Function(Changes from baseline to 4-month and 1-year follow-up)
- Depression, anxiety and stress(Changes from baseline to 4-month and 1-year follow-up)
- Emotional, psychological and social well-being(Changes from baseline to 4-month and 1-year follow-up)
- Cost-effectiveness analysis (CEA)(From baseline to 1-year follow-up)
研究者
Enrique García Artero
Principal Investigator
Universidad de Almeria