The POWER BARIATRIC Trial: Physical Outcomes With Exercise Regimens on BARIATRIC Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Muscle mass (cm3)
研究概览
简要总结
This study aims to determine how different types of exercise regimens (resistance, aerobic, or combined exercise regimens) can be used to minimize muscle loss and mobilize body fat in severely obese patients after bariatric surgery (BS), despite the rapid surgery-induced weight loss. Additionally, the study will examine how changes in the intestinal microbiota following BS act as a mediation factor that alter tissue-specific responses in muscle and adipose tissue. The study will also evaluate the effect of different types of exercise regimens on cardiometabolic markers, endocrine response, and physical function following BS.
Sixty sedentary (regular exercise <1 hour per week) candidates to bariatric surgery at Herzliya Medical Center will be recruited to participate in this six-month-long randomized control study. Participants will be randomly assigned to either one of three exercise regimens intervention groups (aerobic, resistance, or a combined exercise regimen combining aerobic and resistance exercises) or a control group that will receive standard care. Training will be supervised and matched for metabolic equivalent (METs). The intervention will take place at the Sylvan Adams Sports Institute at Tel Aviv University and an online platform.
All measurements will be taken at a presurgical baseline assessment and throughout the study, and will include changes of muscle mass and adipose tissue distribution, measured by a 3-Tesla magnetic resonance imaging (MRI); body composition- will be assessed using multichannel bioelectrical impedance (Seca); Bone mass, will be measured by a Dual-energy X-ray absorptiometry (DEXA); microbiota composition and changes will be evaluated by stool samples that will be subjected to 16S ribosomal ribonucleic acid (16s rRNA) profiling and metagenomics analysis; fasting blood samples will be used to examine endocrine control and cardiometabolic markers; anthropometric measurements to assess surgery results associations with physical activity outcomes and physical function will be assessed by several validated performance assessments, including handgrip, six-minute walk, sit-to-stand, maximum voluntary contraction, and maximal oxygen consumption (VO2max).
详细描述
The primary aim will be to determine how different types of exercise regimens (resistance, aerobic, or combined exercise regimens) can be used to minimize muscle loss and mobilize body fat in severely obese patients after BS, despite the rapid surgery-induced weight loss.
Secondary aims will include: I. To examine the effect of different exercise regimens on the composition and diversity of microbiomes, and their role in mediating muscle mass preservation following BS. II.Evaluate changes in cardiometabolic markers and endocrine response to different exercise regimens and evaluates microbiome mediation of these changes after BS. III.Assess the effect of different exercise regimens on physical function among patients following BS. IV.Clarify the mechanisms of muscle preservation and fat loss involving hormonal response and atrophy related-genes expression.
After baseline measurements (detailed below), participants will be randomized into one of four groups: 1. control group (n=15) that includes routine health care; 2. aerobic exercise training group (n=15), 3. resistance exercise training group (n=15), 4. combined aerobic and resistance exercise training group (n=15). Training sessions will be both in-person and as online exercise supervision. All groups will be supported by a dietitian as part of the routine health care after the bariatric surgery. The dietetic program for all groups will consist of a balanced diet by diet progression guidelines for bariatric patients (XX,ZZ) and the bariatric food pyramid (55). The protein content will be a minimum of 60 gr/protein per day, according to current guidelines (XX,ZZ) . Each training session will increase gradually up to 60 minutes per session, three times a week. Participants will be randomized into 4 groups for 26 weeks of intervention including aerobic, resistance, combined exercise training (aerobic + resistance) and a control group without exercise training.
All exercise training will be matched in metabolic equivalent (METs) and the time of training per week. Participants will begin a two weeks exercise adaptation period at 3-4 postoperative weeks. The activity adaptation plan will consist of 15-20 min. of walking, three times per week, at an intensity of 40-60% of peak oxygen consumption (VO2) or rate of perceived exertion (RPE) 4-6 on the Borg scale for all intervention groups. Following this period, each group will participate in a specific progressive training with the following regimen:
- Aerobic exercise training group, weeks 5-8 after surgery: this training will consist of 30 min. of walking, 3 times per week at an intensity of 60-70% of peak VO2 or RPE 6-7 on Borg scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sedentary participants: regular exercise performed <1 hour per week
- •Candidates for primary bariatric surgery at Herzliya Medical Center in accordance to the National Institutes of Health (NIH) criteria for surgery: (body mass index (BMI) > 40 without coexisting co-morbidities or BMI > 35 with > 1 severe obesity-related comorbidities)
- •Age: 18 to 65 years.
排除标准
- •Severe cardiopulmonary disease (e.g., recent myocardial infarction or unstable angina)
- •Musculoskeletal or neuromuscular impairments that preclude exercise training
- •Cognitive impairments
- •Use of drugs that affect bone or muscle metabolism (mainly steroids)
- •Patients with previous bariatric surgery
结局指标
主要结局
Muscle mass (cm3)
时间窗: At baseline and after 26 weeks of intervention
Changes in thigh muscles volume
Body composition
时间窗: At baseline and after 13 and 26 weeks of intervention
Fat free mass (Kg)
Body composition - fat mass
时间窗: At baseline and after 13 and 26 weeks of intervention
Fat mass (Kg)
次要结局
- Blood measurements - cardiometabolic markers(At baseline and after 13 and 26 weeks of intervention)
- Microbial composition and changes(At baseline and after 13 and 26 weeks of intervention)
- Blood measurements for skeletal muscle metabolism assessment(At baseline and after 13 and 26 weeks of intervention)
- Blood measurements - Inflammatory markers(At baseline and after 13 and 26 weeks of intervention)
- Bone density changes(At baseline and after 13 and 26 weeks of intervention)
- Blood measurements for nutritional status(At baseline and after 13 and 26 weeks of intervention)
- Blood measurements for micronutrients(At baseline and after 13 and 26 weeks of intervention)
- Anthropometric measurements - BMI(At baseline and after 13 and 26 weeks of intervention)
- Blood measurements - Insulin(At baseline and after 13 and 26 weeks of intervention)
- Blood measurements for liver function(At baseline and after 13 and 26 weeks of intervention)
- Blood measurements of adipokines - leptin(At baseline and after 13 and 26 weeks of intervention)
- Blood measurements of adipokines - adiponectin(At baseline and after 13 and 26 weeks of intervention)
- Weight loss percentage outcomes(At baseline and after 13 and 26 weeks of intervention)
- Blood measurements for bone status(At baseline and after 13 and 26 weeks of intervention)
- waist circumference as part of Anthropometric measurements(At baseline and after 13 and 26 weeks of intervention)
- Resting metabolic rate(At baseline and after 13 and 26 weeks of intervention)
研究者
Gepner Yftach
Dr. Gepner Yftach
Tel Aviv University