Exercise to Fight Obesity

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.

Conditions

• Morbid Obesity
• Bariatric Surgery
• Telerehabilitation

Interventions

BEHAVIORAL

Usual Care Group

Participants will receive the standard intervention provided by the healthcare service, which includes recommendations for physical exercise, physical activity, and healthy eating. This intervention is delivered by the Endocrinology and Nutrition Department at Hospital Universitario y Politécnico La Fe and consists of periodic individual follow-ups (at least three in-person visits per year, both pre- and post-bariatric surgery) by specialized medical staff in Endocrinology and licensed Nutrition and Dietetics professionals. Additionally, it includes five preoperative group sessions focusing on various aspects of healthy nutrition, physical exercise, and physical activity.

BEHAVIORAL

Controlled exercise with telerehabilitation

Participants will receive the same standard care as the control group, including the same number of visits with the physician and nutritionist and participation in group sessions. Additionally, they will follow a structured physical exercise program, tailored to individual capabilities, combining aerobic and strength exercises, which will primarily be carried out at home with the assistance of telerehabilitation. Physical exercise will be structured in different phases: prior to surgery (prehabilitation), after surgery (rehabilitation), with maintenance periods in between.

Sponsors & Collaborators

• University of Valencia

  collaborator OTHER

• Universidad Miguel Hernandez de Elche

  collaborator OTHER

• Instituto de Investigacion Sanitaria La Fe

  lead OTHER

Principal Investigators

• Paolo Rossetti, Medicine · IIS La Fe

• Rodrigo Martín · Grupo de investigación Clinimetría y desarrollo tecnológico en ejercicio terapéutico (CLIDET)

• Pilar Masdeu, Medicine · IIS La Fe

• Noemí Moreno · CLIDET

• Ana Belén Crujeiras · Unidad de Epigenómica en el Instituto de Investigación Sanitaria de Santiago (IDIS)

• Maria Dolores Herranz Lopez · Universidad Miguel Hernández

• Adrián Escriche · CLIDET

• Cristina Flor · CLIDET

• Albert Lecube · Sociedad Española para el Estudio de la Obesidad (SEEDO)

• Enrique Roche Collado · Universidad Miguel Hernández

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-19

Primary Completion

2028-12-31

Completion

2029-04-30

Countries

• Spain

Study Locations