Clinical trial NCT06987903: Impact of a Perioperative Physical Exercise and Respiratory Physiotherapy Program on the Patient Undergoing Bariatric Surgery
Official title: Impact of a Perioperative Physical Exercise and Respiratory Physiotherapy Program on the Patient Undergoing Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bariatric Surgery and Physical Activity
Obesity/Therapy
Bariatric Surgery Complications
Bariatric Patients
Keywords: Bariatric surgery
Obesity
Respiratory physiotherapy
Exercise programme
Lead sponsor: Fundacin Biomedica Galicia Sur
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Total weight loss
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Waist circumference
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Sex (at birth)
timeFrame: Once at the inclusion
Secondary outcomes:
measure: Comorbidities
timeFrame: 4 weeks before bariatric surgery
measure: Age
timeFrame: 4 weeks before bariatric surgery
measure: Concomitant medication
timeFrame: 4 weeks before bariatric surgery
measure: Active smoking
timeFrame: 4 weeks before bariatric surgery
measure: Alcohol consumption
timeFrame: 4 weeks before bariatric surgery
measure: Previous abdominal surgeries
timeFrame: 4 weeks before bariatric surgery
measure: Previous bariatric interventions
timeFrame: 4 weeks before bariatric surgery
measure: Weight at inclusion
timeFrame: 4 weeks before bariatric surgery
measure: Height at inclusion
timeFrame: 4 weeks before bariatric surgery
measure: Impedanciometry
timeFrame: 4 weeks before bariatric surgery
measure: ASA Score
timeFrame: 4 weeks before bariatric surgery
measure: Baseline O2 Saturation
timeFrame: 4 weeks before bariatric surgery
measure: Blood glucose
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Haemoglobin A1c
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Total protein
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Albumin
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Pre-Albumin
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Cholesterol
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Triglycerides
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: HDL Cholesterol
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: LDL Cholesterol
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: AST (GOT)
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: ALT (GPT)
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: GGT
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Alkaline phosphatase
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: LDH
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Iron
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Transferrin
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Transferrin saturation rate
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Ferritin
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Vitamin B12
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Folic acid
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Lactate
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Exerkines
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Myokines
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: IL
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Grip strength dynamometry
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Goniometry
timeFrame: 4 weeks before bariatric surgery
measure: Sit to stand Test
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: 6' walk test
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Walking speed test
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: IPAQ
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: ARISCAT
timeFrame: 4 weeks before bariatric surgery
measure: Oral tolerance
timeFrame: Immediate postoperative period up to 12 hours after surgery
measure: Beginning of standing
timeFrame: Immediate postoperative period up to 12 hours after surgery
measure: Urinary catheterisation
timeFrame: Immediate postoperative period up to 12 hours after surgery
measure: Use of respiratory incentive
timeFrame: The first day after surgery
measure: EVA of level of subjetive pain felt
timeFrame: The first, second and third day after surgery
measure: Morbidity/complications
timeFrame: The fourth day after surgery
measure: Days from post-operative period to discharge
timeFrame: The fourth day after surgery
measure: Emergency attendance in the first 30 days from discharge
timeFrame: 8 weeks after discharge
measure: Re-admission in General and Digestive Surgery Department
timeFrame: 8 weeks after discharge
measure: Re-intervention during re-admission
timeFrame: 8 weeks after discharge
measure: Average daily steps
timeFrame: 8 weeks after discharge
measure: Adverse events during exercise
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Compliance with exercise programme.
timeFrame: 8 weeks after discharge
measure: EuroQol 5D (Quality of Life Questionnaire)
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Suter oral tolerance test
timeFrame: 8 weeks after discharge
measure: Surgical Variable: Kind of approach
timeFrame: In bariatric surgery
measure: Surgical Variable: number of trocars
timeFrame: In bariatric surgery
measure: Surgical Variable: surgical technique
timeFrame: In bariatric surgery
measure: Surgical Variable: associated surgery
timeFrame: In bariatric surgery
measure: Surgical Variable: revision surgery
timeFrame: In bariatric surgery
measure: Surgical Variable: opioid-free anesthetic protocol (OFA)
timeFrame: In bariatric surgery
measure: Surgical Variable: Intraoperative pneumatic compression stockings
timeFrame: In bariatric surgery
measure: Surgical Variable: urinary catheterisation
timeFrame: In bariatric surgery
measure: Surgical Variable: intra-abdominal drainage
timeFrame: In bariatric surgery
Other outcomes:
Locations:
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
state: Pontevedra
Study officials:
References: