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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Specific pre- and post-operative physical exercise and respiratory physiotherapy programme. |
|
| Arm 2 | No Intervention | Usual pre- and post-operative procedure without a specific exercise programme. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks before bariatric surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Alvaro Cunqueiro | Recruiting | Vigo | Pontevedra | 36312 | Spain |
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| 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. |
|
| Age |
Age in years |
| 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. | 4 weeks before bariatric surgery |
| Active smoking | Yes/No | 4 weeks before bariatric surgery |
| Alcohol consumption | Alcohol consumption in UBEs or Units of alcohol | 4 weeks before bariatric surgery |
| Previous abdominal surgeries | Yes/No | 4 weeks before bariatric surgery |
| Previous bariatric interventions | Yes/No | 4 weeks before bariatric surgery |
| Weight at inclusion | Kilograms | 4 weeks before bariatric surgery |
| Height at inclusion | Metres | 4 weeks before bariatric surgery |
| Impedanciometry | Fat mass, bone mass, muscle mass, intracellular and extracellular water mass. | 4 weeks before bariatric surgery |
| ASA Score | 4 weeks before bariatric surgery |
| Baseline O2 Saturation | % | 4 weeks before bariatric surgery |
| Blood glucose | mg/dL | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From enrollment to the end of intervention at 8 weeks |
| LDL Cholesterol | mg/dL | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From enrollment to the end of intervention at 8 weeks |
| Ferritin | ng/mL | 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. | From enrollment to the end of intervention at 8 weeks |
| Folic acid | ng/mL | 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. | 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. | From enrollment to the end of intervention at 8 weeks |
| Myokines | ng/mL | From enrollment to the end of intervention at 8 weeks |
| IL | pg/mL | From enrollment to the end of intervention at 8 weeks |
| Grip strength dynamometry | 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. | 4 weeks before bariatric surgery |
| Sit to stand Test | 5 repetitions | From enrollment to the end of intervention at 8 weeks |
| 6' walk test | Distance walked and Vo2max estimation | From enrollment to the end of intervention at 8 weeks |
| Walking speed test | Time to cover 4 metres at usual pace. | From enrollment to the end of intervention at 8 weeks |
| IPAQ | International Physical Activity Questionnaire. High, moderate, low. | 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) | 4 weeks before bariatric surgery |
| Oral tolerance | (YES/NO) | Immediate postoperative period up to 12 hours after surgery |
| Beginning of standing | (YES/NO) | Immediate postoperative period up to 12 hours after surgery |
| Urinary catheterisation | (YES/NO) | Immediate postoperative period up to 12 hours after surgery |
| Use of respiratory incentive | (YES/NO) | 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 | The first, second and third day after surgery |
| Morbidity/complications | (YES/NO) | The fourth day after surgery |
| Days from post-operative period to discharge | Days | The fourth day after surgery |
| Emergency attendance in the first 30 days from discharge | (YES/NO) | 8 weeks after discharge |
| Re-admission in General and Digestive Surgery Department | (YES/NO) | 8 weeks after discharge |
| Re-intervention during re-admission | (YES/NO) | 8 weeks after discharge |
| Average daily steps | 8 weeks after discharge |
| Adverse events during exercise | Dizziness, pain, dyspnoea | From enrollment to the end of intervention at 8 weeks |
| Compliance with exercise programme. | Only in arm 1 participants. (0%, <50%, >50 - <100%, 100%) | 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. | 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. | 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 | In bariatric surgery |
| Surgical Variable: number of trocars | Number of trocars | 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 | In bariatric surgery |
| Surgical Variable: associated surgery | (YES/NO) | In bariatric surgery |
| Surgical Variable: revision surgery | (YES/NO) | In bariatric surgery |
| Surgical Variable: opioid-free anesthetic protocol (OFA) | (YES/NO) | In bariatric surgery |
| Surgical Variable: Intraoperative pneumatic compression stockings | (YES/NO) | In bariatric surgery |
| Surgical Variable: urinary catheterisation | (YES/NO) | In bariatric surgery |
| Surgical Variable: intra-abdominal drainage | (YES/NO) | In bariatric surgery |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007854 | Lead |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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