Impact of a Structured Physical Exercise Program on Body Composition in Morbid Obesity: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- Fat mass percentage
研究概览
简要总结
This clinical trial aims to determinate whether a structured exercise program, supported by telerehabilitation, can help individuals with severe obesity who are going to undergo bariatric surgery.
The main objective of this study is whether a structured exercise program, including both supervised and home-based workouts, leads to greater body fat loss and improved strength compared to usual care. Furthermore, it also aims to evaluate other potentially affected aspects, such as body composition and functionality, quality of life, cardiovascular fitness, and various genetic and metabolic factors.
This study is a randomized clinical trial with two groups:
- The intervention group will follow a structured exercise program both pre- and post- surgery.
- The control group will receive standard care, including nutritional counseling and general health advice.
The study will include 72 adults with severe obesity (36 men and 36 women), all of whom will be randomly assigned to either the intervention or control group.
Participants in the exercise group will follow these steps:
- Before Surgery (Prehabilitation): A 26-week program with aerobic and strength exercises, done in-person or remotely 2-4 times per week.
- Pre-Surgery Maintenance: A flexible period before surgery where participants continue exercising on their own.
- After Surgery (Rehabilitation): A 20-week program focused on recovery and strength.
- Post-Surgery Maintenance: A long-term, self-guided phase to maintain progress.
Participants in the exercise group will also receive the same care as the control group, including nutrition counseling and medical checkups.
To evaluate participant progress, a series of measurements will be carried out, including:
- BMI and body composition
- Physical function assessed through isometric strength tests and other measures such as the Sit-to-Stand test and the 6-Minute Walk Test
- Quality of life and lifestyle assessed using validated questionnaires
- Daily physical activity measured with pedometers
- Metabolic and genetic analysis from blood samples
If proven effective, this program could help establish structured exercise with telerehabilitation as a standard component of obesity care. The results may support the integration of exercise programs into clinical practice, leading to improved long-term outcomes for individuals with severe obesity undergoing bariatric surgery. Additionally, insights into genetic and metabolic factors may contribute to the development of personalized treatment strategies.
详细描述
INTRODUCTION Severe obesity represents a growing public health challenge in Spain, with a marked increase in prevalence and significant implications for morbidity, mortality, and healthcare expenditure. In 2022, nearly 400,000 individuals were affected by class III obesity, reflecting an increase of more than 200% since the 1990s. This condition is strongly associated with serious comorbidities, including cardiovascular disease, type 2 diabetes, and certain cancers, and is linked to a substantial reduction in life expectancy. From an economic perspective, overweight and obesity are estimated to account for approximately 10% of national healthcare costs, with severe obesity contributing significantly through both direct medical expenses and indirect costs related to productivity loss.
Conventional treatment strategies, such as dietary interventions and physical activity (PA), offer limited long-term effectiveness in individuals with severe obesity. Although physical exercise (PE)-a structured form of PA-has shown benefits beyond weight reduction, including improvements in body composition and cardiorespiratory fitness, the majority of participants find it difficult to sustain behavioral changes over time. Furthermore, the degree of weight loss required in this population frequently exceeds what lifestyle interventions alone can achieve.
Bariatric surgery has emerged as an effective alternative, providing substantial short-term weight reduction and improvement in obesity-related comorbidities. However, it is not without limitations, including the loss of lean body mass and the risk of long-term weight regain, particularly in the absence of adequate PA following surgery. Recent studies have shown that postoperative PE programs may improve these outcomes, although the evidence on the benefits of preoperative exercise (prehabilitation) remains limited.
In this context, telerehabilitation appears to be a promising strategy for enhancing accessibility, adherence, and continuity of care. Remote supervision of structured exercise programs, supported by wearable technologies such as activity trackers, may help overcome common barriers and increase participant engagement. Additionally, the substantial variability in individual responses to obesity treatment highlights the need for personalized interventions. Genetic, metabolic, and epigenetic factors likely contribute to treatment resistance in certain individuals, and the identification of predictive biomarkers may help guide more effective and individualized obesity management strategies.
OBJECTIVES:
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Eligible participants who consent to participate will be randomly assigned to either the standard care group or a physical exercise (PE) program incorporating telerehabilitation. Randomization will be performed using permuted blocks of six participants to ensure balanced allocation and concealment. The randomization sequence will be generated by an independent researcher not involved in participant recruitment or group assignment, and will be concealed in sequentially numbered, opaque, and sealed envelopes.
After the baseline assessment, study personnel will open the next envelope in the sequence, and the assigned intervention will commence immediately. To preserve methodological rigor, both the evaluators conducting participant assessments and the researchers performing data analyses will remain blinded to group allocation throughout the study.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-65 years
- •BMI ≥35 with comorbidities, or ≥40, regardless of comorbidity presence
排除标准
- •Participation in a structured physical exercise program within the past 6 months
- •Presence of musculoskeletal or systemic diseases that prevent participation in a physical exercise program
- •Uncontrolled hypertension
- •Uncontrolled diabetes, particularly in the presence of severe complications (neuropathy and/or diabetic foot, proliferative retinopathy)
- •Uncontrolled or unstable cardiovascular disease (acute myocardial infarction within the past year, angina, heart failure, peripheral artery disease)
结局指标
主要结局
Fat mass percentage
时间窗: Baseline, 6 months, perioperative, 6 moths after and 1 year after
The percentage of fat mass relative to the patient's total body mass, measured using bioelectrical impedance analysis (BIA).
Lower limb strength
时间窗: Baseline, 6 months, perioperative, 6 moths after and 1 year after
Measured by the 5 repetitions Sit-To-Stand test (5STS)
次要结局
- Weight(Baseline, 6 months, perioperative, 6 moths after and 1 year after)
- Height(Baseline)
- Waist circumference(Baseline, 6 months, perioperative, 6 moths after and 1 year after)
- Skeletal muscle mass(Baseline, 6 months, perioperative, 6 moths after and 1 year after)
- Lean body mass(Baseline, 6 months, perioperative, 6 moths after and 1 year after)
- Visceral fat area(Baseline, 6 months, perioperative, 6 moths after and 1 year after)
- Blood preasure(Baseline, 6 months, perioperative, 6 moths after and 1 year after)
- Isometric muscle strength(Baseline, 6 months, perioperative, 6 moths after and 1 year after)
- 6 minutes walking test (6MWT)(Baseline, 6 months, perioperative, 6 moths after and 1 year after)
- Short Performance Physical Battery (SPPB)(Baseline, 6 months, perioperative, 6 moths after and 1 year after)
- VO2max/VO2 peak(Baseline, 6 months, perioperative, 6 moths after and 1 year after)
- Steps per day(Baseline, 6 months, perioperative, 6 moths after and 1 year after)
- International Physical Activity Questionnaire (IPAQ):(Baseline, 6 months, perioperative, 6 moths after and 1 year after)
- International Sedentary Assessment Tool (ISAT)(Baseline, 6 months, perioperative, 6 moths after and 1 year after)
- Short Form-36 Health Survey (SF-36)(Baseline, 6 months, perioperative, 6 moths after and 1 year after)
- Impact of Weight on Quality of Life (IWQOL)(Baseline, 6 months, perioperative, 6 moths after and 1 year after)
- Bariatric Analysis and Reporting Outcome System (BAROS)(6 months post-surgery and one year post-surgery.)
- Number of participants with abnormal laboratory tests results(Baseline, 6 months, perioperative, 6 moths after and 1 year after)
- Number of participants with genetic alterations(Baseline (Stored in a biobank for analysis if funding is obtained))
研究者
Paolo Rossetti
Clinical Researcher
Instituto de Investigacion Sanitaria La Fe