Laparoscopic adjustable gastric banding in severely obese adolescents: a randomized trial.
Paul E O'Brien, Susan M Sawyer, Cheryl Laurie...
https://pubmed.ncbi.nlm.nih.gov/20145228Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06934681
Impact of a Structured Physical Exercise Program on Body Composition in Morbid Obesity: A Randomized Controlled Trial
Led by Instituto de Investigacion Sanitaria La Fe · Updated on 2025-06-04
72
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
Sponsors
I
Instituto de Investigacion Sanitaria La Fe
Lead Sponsor
U
University of Valencia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether a structured exercise program supported by telerehabilitation can help adults with severe obesity who are preparing for bariatric surgery. The study aims to determine if this program, which includes supervised and home-based workouts, leads to greater body fat loss and improved lower-limb strength compared to usual care. It also examines effects on body composition, physical function, quality of life, cardiovascular fitness, and genetic and metabolic factors in this population. Participants are randomly assigned to one of two groups: the intervention group follows a structured exercise program before and after surgery, while the control group receives standard care including nutritional counseling and general health advice. The exercise program includes a 26-week prehabilitation phase with aerobic and strength exercises done in person or remotely 2-4 times per week, a flexible pre-surgery maintenance period, a 20-week post-surgery rehabilitation phase focused on recovery and strength, and a long-term self-guided maintenance phase. Both groups receive medical checkups and nutrition counseling. Throughout the study, participants undergo various assessments including measurements of BMI, body composition, physical function tests like the Sit-to-Stand and 6-Minute Walk Test, quality of life questionnaires, daily physical activity tracked by pedometers, and blood tests for metabolic and genetic analysis. Researchers monitor adherence to exercise sessions and evaluate primary outcomes such as fat mass percentage and lower-limb strength at multiple time points before and after surgery. The study also includes a substudy focused solely on postoperative rehabilitation and maintenance.
CONDITIONS
Brief Title
Exercise to Fight Obesity
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Body mass index (BMI) of 35 or higher with comorbidities, or 40 or higher regardless of comorbidities
You will not qualify if you...
- Participation in a structured physical exercise program within the past 6 months
- Musculoskeletal or systemic diseases preventing participation in physical exercise
- Uncontrolled hypertension
- Uncontrolled diabetes with severe complications such as neuropathy, diabetic foot, or proliferative retinopathy
- Uncontrolled or unstable cardiovascular disease, including recent heart attack, angina, heart failure, or peripheral artery disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Prehabilitation
Duration - Up to 6 months before surgery
Participants engage in a structured physical exercise program combining aerobic and strength training, performed both in person and remotely with telerehabilitation support, prior to bariatric surgery. This program is tailored to individual capabilities and aims to reduce fat percentage and improve lower-limb strength.
Regular in-person and remote exercise sessions with periodic assessments
Bariatric Surgery and Immediate Post-operative Care
Duration - Surgery day and immediate recovery period
Participants undergo bariatric surgery followed by immediate post-operative care as part of their obesity treatment.
1 hospitalization period including surgery and immediate recovery
Postoperative Rehabilitation and Maintenance
Duration - Up to 12 months after surgery
Participants follow a rehabilitation and maintenance physical exercise program combining supervised and home-based sessions supported by telerehabilitation after surgery to improve physical function, cardiovascular capacity, and quality of life.
Multiple visits including in-person and remote sessions over 12 months
Follow-up Assessments
Duration - Up to 1 year after surgery
Participants undergo follow-up assessments to monitor body composition, physical function, and quality of life at several time points after surgery.
Assessments at perioperative, 6 months post-surgery, and 12 months post-surgery visits
Trial Site Locations
Total: 2 locations
1
Facultad de Fisioterapia, universidad de Valencia
Valencia, Valencia, Spain, 46010
Active, Not Recruiting
2
Hospital La Fe
Valencia, Valencia, Spain, 46026
Actively Recruiting
Loading map...
Research Team
P
Paolo Rossetti, Medicine
P
Pilar Masdeu, Medicine
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
The disease burden associated with overweight and obesity.
A Must, J Spadano, E H Coakley...
https://pubmed.ncbi.nlm.nih.gov/10546691Impact of Exercise on Body Composition and Cardiometabolic Risk Factors in Patients Awaiting Bariatric Surgery.
A Marc-Hernández, J Ruiz-Tovar, A Aracil...
https://pubmed.ncbi.nlm.nih.gov/31313237The clinical effectiveness and cost-effectiveness of long-term weight management schemes for adults: a systematic review.
E Loveman, G K Frampton, J Shepherd...
https://pubmed.ncbi.nlm.nih.gov/21247515Association of visceral adiposity index with sarcopenia based on NHANES data.
Jianzhao Li, Yuning Lin, Haitang Deng...
https://pubmed.ncbi.nlm.nih.gov/39256533Comparison of DXA and water measurements of body fat following gastric bypass surgery and a physiological model of body water, fat, and muscle composition.
David G Levitt, Lauren M Beckman, Jennifer R Mager...
https://pubmed.ncbi.nlm.nih.gov/20558754Weight recidivism post-bariatric surgery: a systematic review.
Shahzeer Karmali, Balpreet Brar, Xinzhe Shi...
https://pubmed.ncbi.nlm.nih.gov/23996349Healthy weight loss maintenance with exercise, GLP-1 receptor agonist, or both combined followed by one year without treatment: a post-treatment analysis of a randomised placebo-controlled trial.
Simon Birk Kjær Jensen, Martin Bæk Blond, Rasmus Michael Sandsdal...
https://pubmed.ncbi.nlm.nih.gov/38544798Preoperative Physical Activity Level and Exercise Prescription in Adults With Obesity: The Effect on Post-Bariatric Surgery Outcomes.
Georges Jabbour, Rony Ibrahim, Nicola Bragazzi
https://pubmed.ncbi.nlm.nih.gov/35874538Effects of supervised resistance training on fitness and functional strength in patients succeeding bariatric surgery.
Corey J Huck
https://pubmed.ncbi.nlm.nih.gov/25226310