Exercise to Fight Obesity

NCT06934681 | Recruiting

• 1 other identifier: 2024-1010-1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief 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:
• Before Surgery (Prehabilitation): A 26-week program with aerobic and strength exercises, done in-person or remotely 2-4 times per week.
• Pre-Surgery Maintenance: A flexible period before surgery where participants continue exercising on their own.
• After Surgery (Rehabilitation): A 20-week program focused on recovery and strength.
• Post-Surgery Maintenance: A long-term, self-guided phase to maintain progress.
• 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

Keywords

Bariatric surgery; Physical Exercise; Telerehabilitation; Prehabilitation; Rehabilitation; Body composition; Morbid obesity; Functional capacity

Outcome Measures

Primary Outcomes (2)

• Fat mass percentage

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

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

• Lower limb strength

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

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

Secondary Outcomes (19)

• Weight

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

• Height

  Baseline

• Waist circumference

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

• Skeletal muscle mass

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

• Lean body mass

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

Study Arms (2)

Guided physical exercise with telerehabilitation

EXPERIMENTAL

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.

Behavioral: Controlled exercise with telerehabilitation

Common physical exercise recommendations given in routine clinical practice

ACTIVE COMPARATOR

Participants will receive the usual dietary and physical activity recommendations during medical assessments and group sessions.

Behavioral: Usual Care Group

Interventions

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.

Common physical exercise recommendations given in routine clinical practice

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.

Guided physical exercise with telerehabilitation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)
• Uncontrolled or unstable cardiovascular disease (acute myocardial infarction within the past year, angina, heart failure, peripheral artery disease)

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead
• University of Valencia: collaborator
• Universidad Miguel Hernandez de Elche: collaborator

Study Sites (2)

Facultad de Fisioterapia, universidad de Valencia

Valencia, Valencia, 46010, Spain

ACTIVE NOT RECRUITING

Hospital La Fe

Valencia, Valencia, 46026, Spain

RECRUITING

Related Publications (28)

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MeSH Terms

Conditions

Obesity, Morbid; Motor Activity

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Paolo Rossetti, Medicine

  IIS La Fe

  PRINCIPAL INVESTIGATOR

• Rodrigo Martín

  Grupo de investigación Clinimetría y desarrollo tecnológico en ejercicio terapéutico (CLIDET)

  STUDY DIRECTOR

• Pilar Masdeu, Medicine

  IIS La Fe

  STUDY CHAIR

• Noemí Moreno

  CLIDET

  STUDY CHAIR

• Ana Belén Crujeiras

  Unidad de Epigenómica en el Instituto de Investigación Sanitaria de Santiago (IDIS)

  STUDY CHAIR

• Maria Dolores Herranz Lopez

  Universidad Miguel Hernández

  STUDY CHAIR

• Adrián Escriche

  CLIDET

  STUDY CHAIR

• Cristina Flor

  CLIDET

  STUDY CHAIR

• Albert Lecube

  Sociedad Española para el Estudio de la Obesidad (SEEDO)

  STUDY CHAIR

• Enrique Roche Collado

  Universidad Miguel Hernández

  STUDY CHAIR

Central Study Contacts

Paolo Rossetti, Medicine

CONTACT

+34608109913; rossetti_paolo@gva.es

Pilar Masdeu, Medicine

CONTACT

+34645741579; pilarmasdeu97@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Eligible participants who consent to participate will be randomly assigned to either the standard care group or a physical exercise (PE) program incorporating telerehabilitation. Randomization will be performed using permuted blocks of six participants to ensure balanced allocation and concealment. The randomization sequence will be generated by an independent researcher not involved in participant recruitment or group assignment, and will be concealed in sequentially numbered, opaque, and sealed envelopes. After the baseline assessment, study personnel will open the next envelope in the sequence, and the assigned intervention will commence immediately. To preserve methodological rigor, both the evaluators conducting participant assessments and the researchers performing data analyses will remain blinded to group allocation throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Researcher

Model Details: This is a randomized, pragmatic, superiority clinical trial with two parallel groups (1:1 ratio), conducted with participants diagnosed with obesity who are eligible for bariatric surgery (BS). Eligible participants who consent to participate will be randomly assigned to either a structured physical exercise (PE) program consisting of supervised strength training with a physiotherapist and telerehabilitation-based strength and aerobic sessions combined with physical activity (PA) promotion, or to the standard care protocol currently implemented at the hospital, which includes general guidance on physical activity, exercise, and nutrition. Both groups will receive the same nutritional intervention.

Study Record Dates

• First Submitted: March 30, 2025
• First Posted: April 18, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)