An interventional study of Pre- and post-operative physical exercise programme and Pre- and post-operative respiratory physiotherapy in Bariatric Surgery and Physical Activity, Obesity/Therapy and Bariatric Surgery Complications, sponsored by Fundacin Biomedica Galicia Sur. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Fundacin Biomedica Galicia Sur · Not applicable, Interventional, and Health services research
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.
2,426 studies on the registry are indexed under Motor Activity; 1,161 are open to participants now.
This study's planned enrollment of 132 is above the median of 60 across 2,118 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →Fundacin Biomedica Galicia Sur is the lead sponsor of 27 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
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
Usual pre- and post-operative procedure without a specific 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.
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.
Total weight loss
\[(Preoperative weight - Weight at 8 weeks post-operative) / Preoperative weight\]\*100
Time frame: From enrollment to the end of intervention at 8 weeks
Waist circumference
Waist circumference measured in cm
Time frame: From enrollment to the end of intervention at 8 weeks
Sex (at birth)
Time frame: Once at the inclusion
Comorbidities
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.
Time frame: 4 weeks before bariatric surgery
Age
Age in years
Time frame: 4 weeks before bariatric surgery
Concomitant medication
It will indicate which concomitant medication the patient has from a list with the following options: Anticoagulant, antiaggregant, stable GLP1 agonist.
Time frame: 4 weeks before bariatric surgery
Active smoking
Yes/No
Time frame: 4 weeks before bariatric surgery
Alcohol consumption
Alcohol consumption in UBEs or Units of alcohol
Time frame: 4 weeks before bariatric surgery
Previous abdominal surgeries
Yes/No
Time frame: 4 weeks before bariatric surgery
Previous bariatric interventions
Yes/No
Time frame: 4 weeks before bariatric surgery
Weight at inclusion
Kilograms
Time frame: 4 weeks before bariatric surgery
Height at inclusion
Metres
Time frame: 4 weeks before bariatric surgery
Impedanciometry
Fat mass, bone mass, muscle mass, intracellular and extracellular water mass.
Time frame: 4 weeks before bariatric surgery
ASA Score
Time frame: 4 weeks before bariatric surgery
Baseline O2 Saturation
%
Time frame: 4 weeks before bariatric surgery
Blood glucose
mg/dL
Time frame: From enrollment to the end of intervention at 8 weeks
Haemoglobin A1c
% Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Time frame: From enrollment to the end of intervention at 8 weeks
Total protein
g/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Time frame: From enrollment to the end of intervention at 8 weeks
Albumin
g/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Time frame: From enrollment to the end of intervention at 8 weeks
Pre-Albumin
mg/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Time frame: From enrollment to the end of intervention at 8 weeks
Cholesterol
mg/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Time frame: From enrollment to the end of intervention at 8 weeks
Triglycerides
mg/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Time frame: From enrollment to the end of intervention at 8 weeks
HDL Cholesterol
mg/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Time frame: From enrollment to the end of intervention at 8 weeks
LDL Cholesterol
mg/dL
Time frame: From enrollment to the end of intervention at 8 weeks
AST (GOT)
UI/L Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Time frame: From enrollment to the end of intervention at 8 weeks
ALT (GPT)
UI/L Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Time frame: From enrollment to the end of intervention at 8 weeks
GGT
UI/L Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Time frame: From enrollment to the end of intervention at 8 weeks
Alkaline phosphatase
UI/L Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Time frame: From enrollment to the end of intervention at 8 weeks
LDH
UI/L Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Time frame: From enrollment to the end of intervention at 8 weeks
Iron
µg/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Time frame: From enrollment to the end of intervention at 8 weeks
Transferrin
µg/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Time frame: From enrollment to the end of intervention at 8 weeks
Transferrin saturation rate
% Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Time frame: From enrollment to the end of intervention at 8 weeks
Ferritin
ng/mL
Time frame: From enrollment to the end of intervention at 8 weeks
Vitamin B12
pg/mL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Time frame: From enrollment to the end of intervention at 8 weeks
Folic acid
ng/mL
Time frame: From enrollment to the end of intervention at 8 weeks
Lactate
mmol/L Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Time frame: From enrollment to the end of intervention at 8 weeks
Exerkines
ng/mL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.
Time frame: From enrollment to the end of intervention at 8 weeks
Myokines
ng/mL
Time frame: From enrollment to the end of intervention at 8 weeks
IL
pg/mL
Time frame: From enrollment to the end of intervention at 8 weeks
Grip strength dynamometry
Time frame: From enrollment to the end of intervention at 8 weeks
Goniometry
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.
Time frame: 4 weeks before bariatric surgery
Sit to stand Test
5 repetitions
Time frame: From enrollment to the end of intervention at 8 weeks
6' walk test
Distance walked and Vo2max estimation
Time frame: From enrollment to the end of intervention at 8 weeks
Walking speed test
Time to cover 4 metres at usual pace.
Time frame: From enrollment to the end of intervention at 8 weeks
IPAQ
International Physical Activity Questionnaire. High, moderate, low.
Time frame: From enrollment to the end of intervention at 8 weeks
ARISCAT
Score for Postoperative Pulmonary Complications. From 0 (Low risk) to 123 points (High risk)
Time frame: 4 weeks before bariatric surgery
Oral tolerance
(YES/NO)
Time frame: Immediate postoperative period up to 12 hours after surgery
Beginning of standing
(YES/NO)
Time frame: Immediate postoperative period up to 12 hours after surgery
Urinary catheterisation
(YES/NO)
Time frame: Immediate postoperative period up to 12 hours after surgery
Use of respiratory incentive
(YES/NO)
Time frame: The first day after surgery
EVA of level of subjetive pain felt
Visual analog scale from zero (0) to ten (10). Zero being no pain at all, ten being the worst pain imaginable
Time frame: The first, second and third day after surgery
Morbidity/complications
(YES/NO)
Time frame: The fourth day after surgery
Days from post-operative period to discharge
Days
Time frame: The fourth day after surgery
Emergency attendance in the first 30 days from discharge
(YES/NO)
Time frame: 8 weeks after discharge
Re-admission in General and Digestive Surgery Department
(YES/NO)
Time frame: 8 weeks after discharge
Re-intervention during re-admission
(YES/NO)
Time frame: 8 weeks after discharge
Average daily steps
Time frame: 8 weeks after discharge
Adverse events during exercise
Dizziness, pain, dyspnoea
Time frame: From enrollment to the end of intervention at 8 weeks
Compliance with exercise programme.
Only in arm 1 participants. (0%, \<50%, \>50 - \<100%, 100%)
Time frame: 8 weeks after discharge
EuroQol 5D (Quality of Life Questionnaire)
Quality of Life Questionnaire. From 0 to 100, where 100 is the best possible health state.
Time frame: From enrollment to the end of intervention at 8 weeks
Suter oral tolerance test
Questionnaire for assessment of food tolerance after bariatric surgery. From 1 to 27, where 27 is the best food tolerance.
Time frame: 8 weeks after discharge
Surgical Variable: Kind of approach
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
Time frame: In bariatric surgery
Surgical Variable: number of trocars
Number of trocars
Time frame: In bariatric surgery
Surgical Variable: surgical technique
It will indicate which surgical technique from a list with the following options: Gastric bypass, Vertical gastrectomy, Nissen-Sleeve, SADI, Other
Time frame: In bariatric surgery
Surgical Variable: associated surgery
(YES/NO)
Time frame: In bariatric surgery
Surgical Variable: revision surgery
(YES/NO)
Time frame: In bariatric surgery
Surgical Variable: opioid-free anesthetic protocol (OFA)
(YES/NO)
Time frame: In bariatric surgery
Surgical Variable: Intraoperative pneumatic compression stockings
(YES/NO)
Time frame: In bariatric surgery
Surgical Variable: urinary catheterisation
(YES/NO)
Time frame: In bariatric surgery
Surgical Variable: intra-abdominal drainage
(YES/NO)
Time frame: In bariatric surgery
Plan to share: No
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Fundacin Biomedica Galicia Sur