| NCT ID | NCT06934681 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto de Investigacion Sanitaria La Fe |
| Condition | Morbid Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2025-05-19 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2025-05-19 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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: 1. Before Surgery (Prehabilitation): A 26-week program with aerobic and strength exercises, done in-person or remotely 2-4 times per week. 2. Pre-Surgery Maintenance: A flexible period before surgery where participants continue exercising on their own. 3. After Surgery (Rehabilitation): A 20-week program focused on recovery and strength. 4. 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.
Eligibility Criteria
Inclusion Criteria: * Age: 18-65 years * BMI ≥35 with comorbidities, or ≥40, regardless of comorbidity presence Exclusion Criteria: * 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)
Contact & Investigator
Paolo Rossetti, Medicine
PRINCIPAL INVESTIGATOR
IIS La Fe
Frequently Asked Questions
Who can join the NCT06934681 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Morbid Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06934681 currently recruiting?
Yes, NCT06934681 is actively recruiting participants. Contact the research team at rossetti_paolo@gva.es for enrollment information.
Where is the NCT06934681 trial being conducted?
This trial is being conducted at Valencia, Spain, Valencia, Spain.
Who is sponsoring the NCT06934681 clinical trial?
NCT06934681 is sponsored by Instituto de Investigacion Sanitaria La Fe. The principal investigator is Paolo Rossetti, Medicine at IIS La Fe. The trial plans to enroll 72 participants.
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