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NCT06934681Recruiting

Exercise to Fight Obesity

Impact of a Structured Physical Exercise Program on Body Composition in Morbid Obesity: A Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 4 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
72 (estimated)
First submitted
30 Mar 2025
Start date
19 May 2025
Primary completion date
Dec 2028
Lead sponsor
Instituto de Investigacion Sanitaria La Fe
Diseases
Obesity
NCT number
NCT06934681

What you commit to

  • Study type: Interventional
  • Planned participants: 72
  • From 19 May 2025 to the primary completion date, Dec 2028
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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)

Other

  • Participation in a structured physical exercise program within the past 6 months

Who the study is looking for

  • Age: 18-65 years
  • BMI ≥35 with comorbidities, or ≥40, regardless of comorbidity presence

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital La Fe
Coordinator of this site? Confirm its status
ValenciaSpainRecruiting
Facultad de Fisioterapia, universidad de Valencia
Coordinator of this site? Confirm its status
ValenciaSpainActive, not recruiting

This page is information, not medical advice. Discuss any trial with your doctor.