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Impact of a Perioperative Physical Exercise and Respiratory Physiotherapy Program on the Patient Undergoing Bariatric Surgery (CAPS-OB)

F

Fundacin Biomedica Galicia Sur

Status

Enrolling

Conditions

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

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06987903
CAPS-OB

Details and patient eligibility

About

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.

Enrollment

132 estimated patients

Sex

All

Ages

18 to 69 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

132 participants in 2 patient groups

Arm 1
Experimental group
Description:
Specific pre- and post-operative physical exercise and respiratory physiotherapy programme.
Treatment:
Procedure: Pre- and post-operative physical exercise programme
Procedure: Pre- and post-operative respiratory physiotherapy
Arm 2
No Intervention group
Description:
Usual pre- and post-operative procedure without a specific exercise programme.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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