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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Age: 18-65 years

• BMI ≥35 with comorbidities, or ≥40, regardless of comorbidity presence

Locations
Other Locations
Spain
Facultad de Fisioterapia, universidad de Valencia
ACTIVE_NOT_RECRUITING
Valencia
Hospital La Fe
RECRUITING
Valencia
Contact Information
Primary
Paolo Rossetti, Medicine
rossetti_paolo@gva.es
+34608109913
Backup
Pilar Masdeu, Medicine
pilarmasdeu97@gmail.com
+34645741579
Time Frame
Start Date: 2025-05-19
Estimated Completion Date: 2029-04
Participants
Target number of participants: 72
Treatments
Experimental: Guided physical exercise with telerehabilitation
Participants will engage in structured physical exercises, including both aerobic and strength training, guided and monitored by physiotherapists. These exercises will be performed both in person and remotely with the support of telerehabilitation.
Active_comparator: Common physical exercise recommendations given in routine clinical practice
Participants will receive the usual dietary and physical activity recommendations during medical assessments and group sessions.
Related Therapeutic Areas
Sponsors
Collaborators: University of Valencia, Universidad Miguel Hernandez de Elche
Leads: Instituto de Investigacion Sanitaria La Fe

This content was sourced from clinicaltrials.gov