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NCT Number: NCT06987903

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

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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Key information

Conditions

Bariatric Surgery and Physical Activity Bariatric Patients Bariatric Surgery Complications Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity/therapy Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

Location status: Recruiting

Location contact

Marta López Otero, MD

CONTACT

[email protected]

+34

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Total weight loss

    Time frame: From enrollment to the end of intervention at 8 weeks

    [(Preoperative weight - Weight at 8 weeks post-operative) / Preoperative weight]*100

  2. Waist circumference

    Time frame: From enrollment to the end of intervention at 8 weeks

    Waist circumference measured in cm

  3. Sex (at birth)

    Time frame: Once at the inclusion

Secondary outcomes

  1. Comorbidities

    Time frame: 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.

  2. Age

    Time frame: 4 weeks before bariatric surgery

    Age in years

  3. Concomitant medication

    Time frame: 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.

  4. Active smoking

    Time frame: 4 weeks before bariatric surgery

    Yes/No

  5. Alcohol consumption

    Time frame: 4 weeks before bariatric surgery

    Alcohol consumption in UBEs or Units of alcohol

  6. Previous abdominal surgeries

    Time frame: 4 weeks before bariatric surgery

    Yes/No

  7. Previous bariatric interventions

    Time frame: 4 weeks before bariatric surgery

    Yes/No

  8. Weight at inclusion

    Time frame: 4 weeks before bariatric surgery

    Kilograms

  9. Height at inclusion

    Time frame: 4 weeks before bariatric surgery

    Metres

  10. Impedanciometry

    Time frame: 4 weeks before bariatric surgery

    Fat mass, bone mass, muscle mass, intracellular and extracellular water mass.

  11. ASA Score

    Time frame: 4 weeks before bariatric surgery

  12. Baseline O2 Saturation

    Time frame: 4 weeks before bariatric surgery

    %

  13. Blood glucose

    Time frame: From enrollment to the end of intervention at 8 weeks

    mg/dL

  14. Haemoglobin A1c

    Time frame: 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.

  15. Total protein

    Time frame: 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.

  16. Albumin

    Time frame: 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.

  17. Pre-Albumin

    Time frame: 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.

  18. Cholesterol

    Time frame: 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.

  19. Triglycerides

    Time frame: 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.

  20. HDL Cholesterol

    Time frame: 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.

  21. LDL Cholesterol

    Time frame: From enrollment to the end of intervention at 8 weeks

    mg/dL

  22. AST (GOT)

    Time frame: 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.

  23. ALT (GPT)

    Time frame: 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.

  24. GGT

    Time frame: 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.

  25. Alkaline phosphatase

    Time frame: 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.

  26. LDH

    Time frame: 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.

  27. Iron

    Time frame: 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.

  28. Transferrin

    Time frame: 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.

  29. Transferrin saturation rate

    Time frame: 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.

  30. Ferritin

    Time frame: From enrollment to the end of intervention at 8 weeks

    ng/mL

  31. Vitamin B12

    Time frame: 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.

  32. Folic acid

    Time frame: From enrollment to the end of intervention at 8 weeks

    ng/mL

  33. Lactate

    Time frame: 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.

  34. Exerkines

    Time frame: 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.

  35. Myokines

    Time frame: From enrollment to the end of intervention at 8 weeks

    ng/mL

  36. IL

    Time frame: From enrollment to the end of intervention at 8 weeks

    pg/mL

  37. Grip strength dynamometry

    Time frame: From enrollment to the end of intervention at 8 weeks

  38. Goniometry

    Time frame: 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.

  39. Sit to stand Test

    Time frame: From enrollment to the end of intervention at 8 weeks

    5 repetitions

  40. 6' walk test

    Time frame: From enrollment to the end of intervention at 8 weeks

    Distance walked and Vo2max estimation

  41. Walking speed test

    Time frame: From enrollment to the end of intervention at 8 weeks

    Time to cover 4 metres at usual pace.

  42. IPAQ

    Time frame: From enrollment to the end of intervention at 8 weeks

    International Physical Activity Questionnaire. High, moderate, low.

  43. ARISCAT

    Time frame: 4 weeks before bariatric surgery

    Score for Postoperative Pulmonary Complications. From 0 (Low risk) to 123 points (High risk)

  44. Oral tolerance

    Time frame: Immediate postoperative period up to 12 hours after surgery

    (YES/NO)

  45. Beginning of standing

    Time frame: Immediate postoperative period up to 12 hours after surgery

    (YES/NO)

  46. Urinary catheterisation

    Time frame: Immediate postoperative period up to 12 hours after surgery

    (YES/NO)

  47. Use of respiratory incentive

    Time frame: The first day after surgery

    (YES/NO)

  48. EVA of level of subjetive pain felt

    Time frame: 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

  49. Morbidity/complications

    Time frame: The fourth day after surgery

    (YES/NO)

  50. Days from post-operative period to discharge

    Time frame: The fourth day after surgery

    Days

  51. Emergency attendance in the first 30 days from discharge

    Time frame: 8 weeks after discharge

    (YES/NO)

  52. Re-admission in General and Digestive Surgery Department

    Time frame: 8 weeks after discharge

    (YES/NO)

  53. Re-intervention during re-admission

    Time frame: 8 weeks after discharge

    (YES/NO)

  54. Average daily steps

    Time frame: 8 weeks after discharge

  55. Adverse events during exercise

    Time frame: From enrollment to the end of intervention at 8 weeks

    Dizziness, pain, dyspnoea

  56. Compliance with exercise programme.

    Time frame: 8 weeks after discharge

    Only in arm 1 participants. (0%, <50%, >50 - <100%, 100%)

  57. EuroQol 5D (Quality of Life Questionnaire)

    Time frame: 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.

  58. Suter oral tolerance test

    Time frame: 8 weeks after discharge

    Questionnaire for assessment of food tolerance after bariatric surgery. From 1 to 27, where 27 is the best food tolerance.

  59. Surgical Variable: Kind of approach

    Time frame: 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

  60. Surgical Variable: number of trocars

    Time frame: In bariatric surgery

    Number of trocars

  61. Surgical Variable: surgical technique

    Time frame: In bariatric surgery

    It will indicate which surgical technique from a list with the following options:

    Gastric bypass, Vertical gastrectomy, Nissen-Sleeve, SADI, Other

  62. Surgical Variable: associated surgery

    Time frame: In bariatric surgery

    (YES/NO)

  63. Surgical Variable: revision surgery

    Time frame: In bariatric surgery

    (YES/NO)

  64. Surgical Variable: opioid-free anesthetic protocol (OFA)

    Time frame: In bariatric surgery

    (YES/NO)

  65. Surgical Variable: Intraoperative pneumatic compression stockings

    Time frame: In bariatric surgery

    (YES/NO)

  66. Surgical Variable: urinary catheterisation

    Time frame: In bariatric surgery

    (YES/NO)

  67. Surgical Variable: intra-abdominal drainage

    Time frame: In bariatric surgery

    (YES/NO)

Sponsors and collaborators

Lead sponsor

Fundacin Biomedica Galicia Sur

Other

Registry information

Acronym: CAPS-OB

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 23, 2025
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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