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

Not Applicable

Not yet recruiting

• Conditions: Bariatric Surgery and Physical Activity; Obesity/Therapy; Bariatric Surgery Complications; Bariatric Patients

• Registration Number: NCT06987903
• Lead Sponsor: Fundacin Biomedica Galicia Sur

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-17
• Status Verified: 2025-05
• Study Start: 2025-05
• Study First Submitted QC: 2025-05-16
• Last Update Submitted: 2025-05-16
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23
• Primary Completion: 2026-05-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 132

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total weight loss	From enrollment to the end of intervention at 8 weeks	\[(Preoperative weight - Weight at 8 weeks post-operative) / Preoperative weight\]\*100
Waist circumference	From enrollment to the end of intervention at 8 weeks	Waist circumference measured in cm
Sex (at birth)	Once at the inclusion

Secondary Outcome Measures

Name	Time	Method
Total protein	From enrollment to the end of intervention at 8 weeks	g/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Albumin	From enrollment to the end of intervention at 8 weeks	g/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Pre-Albumin	From enrollment to the end of intervention at 8 weeks	mg/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
EVA of level of subjetive pain felt	The first, second and third day after surgery	Visual analog scale from zero (0) to ten (10). Zero being no pain at all, ten being the worst pain imaginable
Morbidity/complications	The fourth day after surgery	(YES/NO)
Days from post-operative period to discharge	The fourth day after surgery	Days
Emergency attendance in the first 30 days from discharge	8 weeks after discharge	(YES/NO)
Re-admission in General and Digestive Surgery Department	8 weeks after discharge	(YES/NO)
Re-intervention during re-admission	8 weeks after discharge	(YES/NO)
Average daily steps	8 weeks after discharge
Adverse events during exercise	From enrollment to the end of intervention at 8 weeks	Dizziness, pain, dyspnoea
Compliance with exercise programme.	8 weeks after discharge	Only in arm 1 participants. (0%, \<50%, \>50 - \<100%, 100%)
Cholesterol	From enrollment to the end of intervention at 8 weeks	mg/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Triglycerides	From enrollment to the end of intervention at 8 weeks	mg/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
EuroQol 5D (Quality of Life Questionnaire)	From enrollment to the end of intervention at 8 weeks	Quality of Life Questionnaire. From 0 to 100, where 100 is the best possible health state.
Suter oral tolerance test	8 weeks after discharge	Questionnaire for assessment of food tolerance after bariatric surgery. From 1 to 27, where 27 is the best food tolerance.
Surgical Variable: revision surgery	In bariatric surgery	(YES/NO)
Surgical Variable: opioid-free anesthetic protocol (OFA)	In bariatric surgery	(YES/NO)
Surgical Variable: Intraoperative pneumatic compression stockings	In bariatric surgery	(YES/NO)
Surgical Variable: urinary catheterisation	In bariatric surgery	(YES/NO)
Surgical Variable: intra-abdominal drainage	In bariatric surgery	(YES/NO)
HDL Cholesterol	From enrollment to the end of intervention at 8 weeks	mg/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
LDL Cholesterol	From enrollment to the end of intervention at 8 weeks	mg/dL
AST (GOT)	From enrollment to the end of intervention at 8 weeks	UI/L Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
ALT (GPT)	From enrollment to the end of intervention at 8 weeks	UI/L Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
GGT	From enrollment to the end of intervention at 8 weeks	UI/L Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Alkaline phosphatase	From enrollment to the end of intervention at 8 weeks	UI/L Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
LDH	From enrollment to the end of intervention at 8 weeks	UI/L Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Iron	From enrollment to the end of intervention at 8 weeks	µg/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Transferrin	From enrollment to the end of intervention at 8 weeks	µg/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Transferrin saturation rate	From enrollment to the end of intervention at 8 weeks	% Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Ferritin	From enrollment to the end of intervention at 8 weeks	ng/mL
Vitamin B12	From enrollment to the end of intervention at 8 weeks	pg/mL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Folic acid	From enrollment to the end of intervention at 8 weeks	ng/mL
Lactate	From enrollment to the end of intervention at 8 weeks	mmol/L Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Exerkines	From enrollment to the end of intervention at 8 weeks	ng/mL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Myokines	From enrollment to the end of intervention at 8 weeks	ng/mL
IL	From enrollment to the end of intervention at 8 weeks	pg/mL
Grip strength dynamometry	From enrollment to the end of intervention at 8 weeks
Goniometry	4 weeks before bariatric surgery	Joint goniometry of the main joints of the extremities (shoulder, elbow, wrist, hip, knee, ankle) will be performed to rule out important joint limitations that also require some type of adaptation in the exercise program.
Sit to stand Test	From enrollment to the end of intervention at 8 weeks	5 repetitions
6' walk test	From enrollment to the end of intervention at 8 weeks	Distance walked and Vo2max estimation
Walking speed test	From enrollment to the end of intervention at 8 weeks	Time to cover 4 metres at usual pace.
IPAQ	From enrollment to the end of intervention at 8 weeks	International Physical Activity Questionnaire. High, moderate, low.
Impedanciometry	4 weeks before bariatric surgery	Fat mass, bone mass, muscle mass, intracellular and extracellular water mass.
ASA Score	4 weeks before bariatric surgery
Baseline O2 Saturation	4 weeks before bariatric surgery	%
Blood glucose	From enrollment to the end of intervention at 8 weeks	mg/dL
Haemoglobin A1c	From enrollment to the end of intervention at 8 weeks	% Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
ARISCAT	4 weeks before bariatric surgery	Score for Postoperative Pulmonary Complications. From 0 (Low risk) to 123 points (High risk)
Oral tolerance	Immediate postoperative period up to 12 hours after surgery	(YES/NO)
Beginning of standing	Immediate postoperative period up to 12 hours after surgery	(YES/NO)
Urinary catheterisation	Immediate postoperative period up to 12 hours after surgery	(YES/NO)
Use of respiratory incentive	The first day after surgery	(YES/NO)
Surgical Variable: Kind of approach	In bariatric surgery	It will indicate which kind of approach from a list with the following options: Simple laparoscopy, 3D Laparoscopy, Single port, Reduced ports, Assisted robotics (DaVinci Xi), Laparotomy
Surgical Variable: number of trocars	In bariatric surgery	Number of trocars
Surgical Variable: surgical technique	In bariatric surgery	It will indicate which surgical technique from a list with the following options: Gastric bypass, Vertical gastrectomy, Nissen-Sleeve, SADI, Other
Surgical Variable: associated surgery	In bariatric surgery	(YES/NO)
Comorbidities	4 weeks before bariatric surgery	It will indicate which comorbidities the patient has from a list with the following options: Hypertension, type 2 diabetes mellitus, dyslipidaemia, COPD, OSAS / OSHS, cardiovascular, GERD, arthropathy, infertility, neoplasias, psoriasis, hepatics, deppresion.
Age	4 weeks before bariatric surgery	Age in years
Concomitant medication	4 weeks before bariatric surgery	It will indicate which concomitant medication the patient has from a list with the following options: Anticoagulant, antiaggregant, stable GLP1 agonist.
Active smoking	4 weeks before bariatric surgery	Yes/No
Alcohol consumption	4 weeks before bariatric surgery	Alcohol consumption in UBEs or Units of alcohol
Previous abdominal surgeries	4 weeks before bariatric surgery	Yes/No
Previous bariatric interventions	4 weeks before bariatric surgery	Yes/No
Weight at inclusion	4 weeks before bariatric surgery	Kilograms
Height at inclusion	4 weeks before bariatric surgery	Metres

Trial Locations

Locations (1)

Hospital Alvaro Cunqueiro; 🇪🇸 Vigo, Pontevedra, Spain