Impact of a Perioperative Physical Exercise and Respiratory Physiotherapy Program on the Patient Undergoing Bariatric Surgery

NCT ID: NCT06987903

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-07
• Study Completion Date: 2026-09-07

Brief Summary

The goal of this clinical trial is to see the impact of a physical exercise programme and respiratory physiotherapy before and after bariatric surgery in obese patients. The main questions it aims to answer are:

Could it help to avoid decompensation of underlying diseases? Could it reduce the risks associated with the intervention and the number of adverse effects during the postoperative period? Could it reduce the number of patients and encourage early discharge? How does exercise affect epigenetics in obese patients undergoing bariatric surgery? Can we correlate epigenectic markers obtained from tissue obtained by invasive procedures such as fat or muscle to those obtained by non-invasive methods such as blood and saliva samples? How does exercise affect the hepatic tissue in obese patients undergoing bariatric surgery? And are the any predictive markers in pre-exercise samples that can correlate with the evolution of liver diseases such asl NALFD or NASH?

Researchers will compare one group of subjects performing the exercise programme and respiratory physiotherapy and anoher group performing the normal activities of routine clinical practice.

Participants, who are on the surgical waiting list for bariatric surgery, will be assigned to one of the two groups. Participants in group 2 will follow the normal procedure before and after surgery. Participants in group 1 will be asked to do a exercise programme and respiratory physiotherapy before and after surgery.

Conditions

Bariatric Surgery and Physical Activity; Obesity/Therapy; Bariatric Surgery Complications; Bariatric Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Arm 1

Specific pre- and post-operative physical exercise and respiratory physiotherapy programme.

Group Type: EXPERIMENTAL

Pre- and post-operative physical exercise programme

Intervention Type: PROCEDURE

Pre- and post-operative physical exercise programme during 4 weeks before bariatric surgery and during 8 weeks after bariatric surgery for arm 1 participants.

A program will be designed according to the needs and preferences of the individual and will include:

Aerobic exercise: Activities that mobilize large muscle groups for prolonged periods of time.Walking, running at a slow or moderate pace (especially on a treadmill), cycling, cycloergometer, etc. In addition, due to the characteristics of the patients, the recommended exercises will be of low impact.

Strength exercise: Exercises of large muscle groups with intensities adapted to patients using body weight or elastic bands of different resistances.

Flexibility exercise: Stretching exercises will be included during the warm-up and cool-down of each exercise session of the program.

Pre- and post-operative respiratory physiotherapy

Intervention Type: PROCEDURE

Pre- and post-operative respiratory physiotherapy during 4 weeks before bariatric surgery and during 8 weeks after bariatric surgery for arm 1 participants.

Breathing exercises:

Abdomino-diaphragmatic respiratory control exercises, costo-diaphragmatic respiratory control exercises, costo-diaphragmatic breathing control exercises, exercises with costal expansion and arm elevation and breathing exercises with pursed lips in different positions.

Incentive spirometry:

Incentive spirometry with the performance of slow, deep breaths in a volumetric incentive device.

Arm 2

Usual pre- and post-operative procedure without a specific exercise programme.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pre- and post-operative physical exercise programme

Pre- and post-operative physical exercise programme during 4 weeks before bariatric surgery and during 8 weeks after bariatric surgery for arm 1 participants.

A program will be designed according to the needs and preferences of the individual and will include:

Aerobic exercise: Activities that mobilize large muscle groups for prolonged periods of time.Walking, running at a slow or moderate pace (especially on a treadmill), cycling, cycloergometer, etc. In addition, due to the characteristics of the patients, the recommended exercises will be of low impact.

Strength exercise: Exercises of large muscle groups with intensities adapted to patients using body weight or elastic bands of different resistances.

Flexibility exercise: Stretching exercises will be included during the warm-up and cool-down of each exercise session of the program.

Intervention Type: PROCEDURE

Pre- and post-operative respiratory physiotherapy

Pre- and post-operative respiratory physiotherapy during 4 weeks before bariatric surgery and during 8 weeks after bariatric surgery for arm 1 participants.

Breathing exercises:

Abdomino-diaphragmatic respiratory control exercises, costo-diaphragmatic respiratory control exercises, costo-diaphragmatic breathing control exercises, exercises with costal expansion and arm elevation and breathing exercises with pursed lips in different positions.

Incentive spirometry:

Incentive spirometry with the performance of slow, deep breaths in a volumetric incentive device.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients undergoing bariatric surgery at the General and Digestive Surgery Department of the Álvaro Cunqueiro Hospital in Vigo.
• Be over 18 and under 69 years old.
• Sign the informed consent to participate in the study.

Exclusion Criteria

• Patient's refusal to enter the study.
• Inability to comprehend participation in a study.
• Urgent interventions.
• Patients undergoing combined surgery with another surgical service.
• Patients who cannot read and write or are dependent on a legal representative.
• Patients on treatment for diabetes with GLP-1 agonists (glucagon-like peptide type 1 agonists) and/or SGLT2 inhibitors (sodium-glucose cotransporter type 2 inhibitors) whose dose is not stable in the last 3 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacin Biomedica Galicia Sur

OTHER

Sponsor Role: lead

Responsible Party

Marta López Otero

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Marta López Otero, MD

Role: primary

Marta.Lopez.Otero@sergas.es

+34

Other Identifiers

CAPS-OB

Identifier Type: -

Identifier Source: org_study_id