Exercise to Fight Obesity

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorInstituto de Investigacion Sanitaria La Fe

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age: 18-65 years

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Usual Care Group

    Behavioral

    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.

  • Controlled exercise with telerehabilitation

    Behavioral

    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.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Guided physical exercise with telerehabilitationExperimental treatment 1 intervention
Group B: Common physical exercise recommendations given in routine clinical practiceActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Fat mass percentage

The percentage of fat mass relative to the patient's total body mass, measured using bioelectrical impedance analysis (BIA).

Time frame
Baseline, 6 months, perioperative, 6 moths after and 1 year after
2

Lower limb strength

Measured by the 5 repetitions Sit-To-Stand test (5STS)

Time frame
Baseline, 6 months, perioperative, 6 moths after and 1 year after

Secondary outcomes

1

Weight

Measured with BIA machine. Units: kilograms

Time frame
Baseline, 6 months, perioperative, 6 moths after and 1 year after
2

Height

Measured using a stadiometer permanently fixed to a wall to minimize variability between patients. Units: meters

Time frame
Baseline
3

Waist circumference

Measured with a non-elastic tape measure. Units: centimeters

Time frame
Baseline, 6 months, perioperative, 6 moths after and 1 year after
4

Skeletal muscle mass

Measured using bioelectrical impedance analysis (BIA).

Time frame
Baseline, 6 months, perioperative, 6 moths after and 1 year after

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Instituto de Investigacion Sanitaria La Fe

Lead sponsor

University of Valencia

Collaborator

Universidad Miguel Hernandez de Elche

Collaborator