Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-01-02 @ 2:27 AM
Study NCT ID:
NCT06987903
Status:
RECRUITING
Last Update Posted:
2025-09-04
First Post:
2024-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of a Perioperative Physical Exercise and Respiratory Physiotherapy Program on the Patient Undergoing Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007854', 'term': 'Lead'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-09-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2024-12-17', 'studyFirstSubmitQcDate': '2025-05-16', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total weight loss', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': '\\[(Preoperative weight - Weight at 8 weeks post-operative) / Preoperative weight\\]\\*100'}, {'measure': 'Waist circumference', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'Waist circumference measured in cm'}, {'measure': 'Sex (at birth)', 'timeFrame': 'Once at the inclusion'}], 'secondaryOutcomes': [{'measure': 'Comorbidities', 'timeFrame': '4 weeks before bariatric surgery', 'description': 'It will indicate which comorbidities the patient has from a list with the following options:\n\nHypertension, type 2 diabetes mellitus, dyslipidaemia, COPD, OSAS / OSHS, cardiovascular, GERD, arthropathy, infertility, neoplasias, psoriasis, hepatics, deppresion.'}, {'measure': 'Age', 'timeFrame': '4 weeks before bariatric surgery', 'description': 'Age in years'}, {'measure': 'Concomitant medication', 'timeFrame': '4 weeks before bariatric surgery', 'description': 'It will indicate which concomitant medication the patient has from a list with the following options:\n\nAnticoagulant, antiaggregant, stable GLP1 agonist.'}, {'measure': 'Active smoking', 'timeFrame': '4 weeks before bariatric surgery', 'description': 'Yes/No'}, {'measure': 'Alcohol consumption', 'timeFrame': '4 weeks before bariatric surgery', 'description': 'Alcohol consumption in UBEs or Units of alcohol'}, {'measure': 'Previous abdominal surgeries', 'timeFrame': '4 weeks before bariatric surgery', 'description': 'Yes/No'}, {'measure': 'Previous bariatric interventions', 'timeFrame': '4 weeks before bariatric surgery', 'description': 'Yes/No'}, {'measure': 'Weight at inclusion', 'timeFrame': '4 weeks before bariatric surgery', 'description': 'Kilograms'}, {'measure': 'Height at inclusion', 'timeFrame': '4 weeks before bariatric surgery', 'description': 'Metres'}, {'measure': 'Impedanciometry', 'timeFrame': '4 weeks before bariatric surgery', 'description': 'Fat mass, bone mass, muscle mass, intracellular and extracellular water mass.'}, {'measure': 'ASA Score', 'timeFrame': '4 weeks before bariatric surgery'}, {'measure': 'Baseline O2 Saturation', 'timeFrame': '4 weeks before bariatric surgery', 'description': '%'}, {'measure': 'Blood glucose', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'mg/dL'}, {'measure': 'Haemoglobin A1c', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': '% Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.'}, {'measure': 'Total protein', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'g/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.'}, {'measure': 'Albumin', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'g/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.'}, {'measure': 'Pre-Albumin', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'mg/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.'}, {'measure': 'Cholesterol', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'mg/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.'}, {'measure': 'Triglycerides', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'mg/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.'}, {'measure': 'HDL Cholesterol', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'mg/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.'}, {'measure': 'LDL Cholesterol', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'mg/dL'}, {'measure': 'AST (GOT)', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'UI/L Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.'}, {'measure': 'ALT (GPT)', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'UI/L Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.'}, {'measure': 'GGT', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'UI/L Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.'}, {'measure': 'Alkaline phosphatase', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'UI/L Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.'}, {'measure': 'LDH', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'UI/L Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.'}, {'measure': 'Iron', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'µg/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.'}, {'measure': 'Transferrin', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'µg/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.'}, {'measure': 'Transferrin saturation rate', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': '% Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.'}, {'measure': 'Ferritin', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'ng/mL'}, {'measure': 'Vitamin B12', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'pg/mL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.'}, {'measure': 'Folic acid', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'ng/mL'}, {'measure': 'Lactate', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'mmol/L Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.'}, {'measure': 'Exerkines', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'ng/mL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.'}, {'measure': 'Myokines', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'ng/mL'}, {'measure': 'IL', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'pg/mL'}, {'measure': 'Grip strength dynamometry', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks'}, {'measure': 'Goniometry', 'timeFrame': '4 weeks before bariatric surgery', 'description': '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.'}, {'measure': 'Sit to stand Test', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': '5 repetitions'}, {'measure': "6' walk test", 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'Distance walked and Vo2max estimation'}, {'measure': 'Walking speed test', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'Time to cover 4 metres at usual pace.'}, {'measure': 'IPAQ', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'International Physical Activity Questionnaire. High, moderate, low.'}, {'measure': 'ARISCAT', 'timeFrame': '4 weeks before bariatric surgery', 'description': 'Score for Postoperative Pulmonary Complications. From 0 (Low risk) to 123 points (High risk)'}, {'measure': 'Oral tolerance', 'timeFrame': 'Immediate postoperative period up to 12 hours after surgery', 'description': '(YES/NO)'}, {'measure': 'Beginning of standing', 'timeFrame': 'Immediate postoperative period up to 12 hours after surgery', 'description': '(YES/NO)'}, {'measure': 'Urinary catheterisation', 'timeFrame': 'Immediate postoperative period up to 12 hours after surgery', 'description': '(YES/NO)'}, {'measure': 'Use of respiratory incentive', 'timeFrame': 'The first day after surgery', 'description': '(YES/NO)'}, {'measure': 'EVA of level of subjetive pain felt', 'timeFrame': 'The first, second and third day after surgery', 'description': 'Visual analog scale from zero (0) to ten (10). Zero being no pain at all, ten being the worst pain imaginable'}, {'measure': 'Morbidity/complications', 'timeFrame': 'The fourth day after surgery', 'description': '(YES/NO)'}, {'measure': 'Days from post-operative period to discharge', 'timeFrame': 'The fourth day after surgery', 'description': 'Days'}, {'measure': 'Emergency attendance in the first 30 days from discharge', 'timeFrame': '8 weeks after discharge', 'description': '(YES/NO)'}, {'measure': 'Re-admission in General and Digestive Surgery Department', 'timeFrame': '8 weeks after discharge', 'description': '(YES/NO)'}, {'measure': 'Re-intervention during re-admission', 'timeFrame': '8 weeks after discharge', 'description': '(YES/NO)'}, {'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', 'description': 'Dizziness, pain, dyspnoea'}, {'measure': 'Compliance with exercise programme.', 'timeFrame': '8 weeks after discharge', 'description': 'Only in arm 1 participants. (0%, \\<50%, \\>50 - \\<100%, 100%)'}, {'measure': 'EuroQol 5D (Quality of Life Questionnaire)', 'timeFrame': 'From enrollment to the end of intervention at 8 weeks', 'description': 'Quality of Life Questionnaire. From 0 to 100, where 100 is the best possible health state.'}, {'measure': 'Suter oral tolerance test', 'timeFrame': '8 weeks after discharge', 'description': 'Questionnaire for assessment of food tolerance after bariatric surgery. From 1 to 27, where 27 is the best food tolerance.'}, {'measure': 'Surgical Variable: Kind of approach', 'timeFrame': 'In bariatric surgery', 'description': 'It will indicate which kind of approach from a list with the following options:\n\nSimple laparoscopy, 3D Laparoscopy, Single port, Reduced ports, Assisted robotics (DaVinci Xi), Laparotomy'}, {'measure': 'Surgical Variable: number of trocars', 'timeFrame': 'In bariatric surgery', 'description': 'Number of trocars'}, {'measure': 'Surgical Variable: surgical technique', 'timeFrame': 'In bariatric surgery', 'description': 'It will indicate which surgical technique from a list with the following options:\n\nGastric bypass, Vertical gastrectomy, Nissen-Sleeve, SADI, Other'}, {'measure': 'Surgical Variable: associated surgery', 'timeFrame': 'In bariatric surgery', 'description': '(YES/NO)'}, {'measure': 'Surgical Variable: revision surgery', 'timeFrame': 'In bariatric surgery', 'description': '(YES/NO)'}, {'measure': 'Surgical Variable: opioid-free anesthetic protocol (OFA)', 'timeFrame': 'In bariatric surgery', 'description': '(YES/NO)'}, {'measure': 'Surgical Variable: Intraoperative pneumatic compression stockings', 'timeFrame': 'In bariatric surgery', 'description': '(YES/NO)'}, {'measure': 'Surgical Variable: urinary catheterisation', 'timeFrame': 'In bariatric surgery', 'description': '(YES/NO)'}, {'measure': 'Surgical Variable: intra-abdominal drainage', 'timeFrame': 'In bariatric surgery', 'description': '(YES/NO)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bariatric surgery', 'Obesity', 'Respiratory physiotherapy', 'Exercise programme'], 'conditions': ['Bariatric Surgery and Physical Activity', 'Obesity/Therapy', 'Bariatric Surgery Complications', 'Bariatric Patients']}, 'descriptionModule': {'briefSummary': '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:\n\nCould 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?\n\nResearchers will compare one group of subjects performing the exercise programme and respiratory physiotherapy and anoher group performing the normal activities of routine clinical practice.\n\nParticipants, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients undergoing bariatric surgery at the General and Digestive Surgery Department of the Álvaro Cunqueiro Hospital in Vigo.\n* Be over 18 and under 69 years old.\n* Sign the informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Patient's refusal to enter the study.\n* Inability to comprehend participation in a study.\n* Urgent interventions.\n* Patients undergoing combined surgery with another surgical service.\n* Patients who cannot read and write or are dependent on a legal representative.\n* 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."}, 'identificationModule': {'nctId': 'NCT06987903', 'acronym': 'CAPS-OB', 'briefTitle': 'Impact of a Perioperative Physical Exercise and Respiratory Physiotherapy Program on the Patient Undergoing Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Fundacin Biomedica Galicia Sur'}, 'officialTitle': 'Impact of a Perioperative Physical Exercise and Respiratory Physiotherapy Program on the Patient Undergoing Bariatric Surgery', 'orgStudyIdInfo': {'id': 'CAPS-OB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Specific pre- and post-operative physical exercise and respiratory physiotherapy programme.', 'interventionNames': ['Procedure: Pre- and post-operative physical exercise programme', 'Procedure: Pre- and post-operative respiratory physiotherapy']}, {'type': 'NO_INTERVENTION', 'label': 'Arm 2', 'description': 'Usual pre- and post-operative procedure without a specific exercise programme.'}], 'interventions': [{'name': 'Pre- and post-operative physical exercise programme', 'type': 'PROCEDURE', 'description': 'Pre- and post-operative physical exercise programme during 4 weeks before bariatric surgery and during 8 weeks after bariatric surgery for arm 1 participants.\n\nA program will be designed according to the needs and preferences of the individual and will include:\n\nAerobic 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.\n\nStrength exercise: Exercises of large muscle groups with intensities adapted to patients using body weight or elastic bands of different resistances.\n\nFlexibility exercise: Stretching exercises will be included during the warm-up and cool-down of each exercise session of the program.', 'armGroupLabels': ['Arm 1']}, {'name': 'Pre- and post-operative respiratory physiotherapy', 'type': 'PROCEDURE', 'description': 'Pre- and post-operative respiratory physiotherapy during 4 weeks before bariatric surgery and during 8 weeks after bariatric surgery for arm 1 participants.\n\nBreathing exercises:\n\nAbdomino-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.\n\nIncentive spirometry:\n\nIncentive spirometry with the performance of slow, deep breaths in a volumetric incentive device.', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36312', 'city': 'Vigo', 'state': 'Pontevedra', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Marta López Otero, MD', 'role': 'CONTACT', 'email': 'Marta.Lopez.Otero@sergas.es', 'phone': '+34'}], 'facility': 'Hospital Alvaro Cunqueiro', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacin Biomedica Galicia Sur', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marta López Otero', 'investigatorAffiliation': 'Fundacin Biomedica Galicia Sur'}}}}