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

NCT06987903 | Recruiting

• 1 other identifier: CAPS-OB
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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

Keywords

Bariatric surgery; Obesity; Respiratory physiotherapy; Exercise programme

Outcome Measures

Primary Outcomes (3)

• Total weight loss

  \[(Preoperative weight - Weight at 8 weeks post-operative) / Preoperative weight\]\*100

  From enrollment to the end of intervention at 8 weeks

• Waist circumference

  Waist circumference measured in cm

  From enrollment to the end of intervention at 8 weeks

• Sex (at birth)

  Once at the inclusion

Secondary Outcomes (67)

• Comorbidities

  4 weeks before bariatric surgery

• Age

  4 weeks before bariatric surgery

• Concomitant medication

  4 weeks before bariatric surgery

• Active smoking

  4 weeks before bariatric surgery

• Alcohol consumption

  4 weeks before bariatric surgery

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Procedure: Pre- and post-operative physical exercise programme; Procedure: Pre- and post-operative respiratory physiotherapy

Arm 2

NO INTERVENTION

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

Interventions

Pre- and post-operative physical exercise programme 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.

Arm 1

Pre- and post-operative respiratory physiotherapy 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 1

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacin Biomedica Galicia Sur: lead

Study Sites (1)

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

RECRUITING

MeSH Terms

Conditions

Motor Activity; Obesity

Interventions

Lead

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: May 23, 2025
• Study Start: May 7, 2025
• Primary Completion: May 7, 2026
• Study Completion (Estimated): September 7, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)