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Bariatric Surgery and Physical ActivityCAPS-OBNCT06987903

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

A study testing Pre- and post-operative physical exercise programme and Pre- and post-operative respiratory physiotherapy in people with Bariatric Surgery and Physical Activity and Obesity/Therapy, run by Fundacin Biomedica Galicia Sur at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 69 years
What is being tested?
Pre- and post-operative physical exercise programme and Pre- and post-operative respiratory physiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
1 siteSpain
Study dates
7 May 2025to 30 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Spain1 site, 1 recruiting

  • Hospital Alvaro Cunqueiro

    Vigo, Pontevedra, 36312

    Marta López Otero, MD, +34, Marta.Lopez.Otero@sergas.es

    Recruiting

Other trials in Spain

About this study

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?

Read more

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.

Being tested
Pre- and post-operative physical exercise programme, Pre- and post-operative respiratory physiotherapy
Keywords
Bariatric surgery, Obesity, Respiratory physiotherapy, Exercise programme
Medical subject headings
Motor Activity, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pre- and post-operative physical exercise programmeProcedure or surgery

    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 physiotherapyProcedure or surgery

    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.

Study groups in NCT06987903
Study groupRoleWhat they receive
Arm 1ExperimentalSpecific pre- and post-operative physical exercise and respiratory physiotherapy programme.
Receives: Procedure: Pre- and post-operative physical exercise programme; Procedure: Pre- and post-operative respiratory physiotherapy
Arm 2No interventionUsual pre- and post-operative procedure without a specific exercise programme.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total weight loss

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

    Measured: From enrollment to the end of intervention at 8 weeks

  2. Waist circumference

    Waist circumference measured in cm

    Measured: From enrollment to the end of intervention at 8 weeks

  3. Sex (at birth)

    Measured: Once at the inclusion

Secondary outcomes (67)

  1. 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.

    Measured: 4 weeks before bariatric surgery

  2. Age

    Age in years

    Measured: 4 weeks before bariatric surgery

  3. Concomitant medication

    It will indicate which concomitant medication the patient has from a list with the following options:

    Anticoagulant, antiaggregant, stable GLP1 agonist.

    Measured: 4 weeks before bariatric surgery

  4. Active smoking

    Yes/No

    Measured: 4 weeks before bariatric surgery

  5. Alcohol consumption

    Alcohol consumption in UBEs or Units of alcohol

    Measured: 4 weeks before bariatric surgery

  6. Previous abdominal surgeries

    Yes/No

    Measured: 4 weeks before bariatric surgery

  7. Previous bariatric interventions

    Yes/No

    Measured: 4 weeks before bariatric surgery

  8. Weight at inclusion

    Kilograms

    Measured: 4 weeks before bariatric surgery

  9. Height at inclusion

    Metres

    Measured: 4 weeks before bariatric surgery

  10. Impedanciometry

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

    Measured: 4 weeks before bariatric surgery

  11. ASA Score

    Measured: 4 weeks before bariatric surgery

  12. Baseline O2 Saturation

    %

    Measured: 4 weeks before bariatric surgery

  13. Blood glucose

    mg/dL

    Measured: From enrollment to the end of intervention at 8 weeks

  14. Haemoglobin A1c

    % Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.

    Measured: From enrollment to the end of intervention at 8 weeks

  15. Total protein

    g/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.

    Measured: From enrollment to the end of intervention at 8 weeks

  16. Albumin

    g/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.

    Measured: From enrollment to the end of intervention at 8 weeks

  17. Pre-Albumin

    mg/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.

    Measured: From enrollment to the end of intervention at 8 weeks

  18. Cholesterol

    mg/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.

    Measured: From enrollment to the end of intervention at 8 weeks

  19. Triglycerides

    mg/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.

    Measured: From enrollment to the end of intervention at 8 weeks

  20. HDL Cholesterol

    mg/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.

    Measured: From enrollment to the end of intervention at 8 weeks

  21. LDL Cholesterol

    mg/dL

    Measured: From enrollment to the end of intervention at 8 weeks

  22. AST (GOT)

    UI/L Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.

    Measured: From enrollment to the end of intervention at 8 weeks

  23. ALT (GPT)

    UI/L Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.

    Measured: From enrollment to the end of intervention at 8 weeks

  24. GGT

    UI/L Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.

    Measured: From enrollment to the end of intervention at 8 weeks

  25. Alkaline phosphatase

    UI/L Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.

    Measured: From enrollment to the end of intervention at 8 weeks

  26. LDH

    UI/L Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.

    Measured: From enrollment to the end of intervention at 8 weeks

  27. Iron

    µg/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.

    Measured: From enrollment to the end of intervention at 8 weeks

  28. Transferrin

    µg/dL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.

    Measured: From enrollment to the end of intervention at 8 weeks

  29. Transferrin saturation rate

    % Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.

    Measured: From enrollment to the end of intervention at 8 weeks

  30. Ferritin

    ng/mL

    Measured: From enrollment to the end of intervention at 8 weeks

  31. Vitamin B12

    pg/mL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.

    Measured: From enrollment to the end of intervention at 8 weeks

  32. Folic acid

    ng/mL

    Measured: From enrollment to the end of intervention at 8 weeks

  33. Lactate

    mmol/L Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.

    Measured: From enrollment to the end of intervention at 8 weeks

  34. Exerkines

    ng/mL Myokines and exerkines, lactate, insulin. Oxidative stress markers. DNA methylation profile and gene expression. Lipidomic and metabolomic profile.

    Measured: From enrollment to the end of intervention at 8 weeks

  35. Myokines

    ng/mL

    Measured: From enrollment to the end of intervention at 8 weeks

  36. IL

    pg/mL

    Measured: From enrollment to the end of intervention at 8 weeks

  37. Grip strength dynamometry

    Measured: From enrollment to the end of intervention at 8 weeks

  38. 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.

    Measured: 4 weeks before bariatric surgery

  39. Sit to stand Test

    5 repetitions

    Measured: From enrollment to the end of intervention at 8 weeks

  40. 6' walk test

    Distance walked and Vo2max estimation

    Measured: From enrollment to the end of intervention at 8 weeks

  41. Walking speed test

    Time to cover 4 metres at usual pace.

    Measured: From enrollment to the end of intervention at 8 weeks

  42. IPAQ

    International Physical Activity Questionnaire. High, moderate, low.

    Measured: From enrollment to the end of intervention at 8 weeks

  43. ARISCAT

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

    Measured: 4 weeks before bariatric surgery

  44. Oral tolerance

    (YES/NO)

    Measured: Immediate postoperative period up to 12 hours after surgery

  45. Beginning of standing

    (YES/NO)

    Measured: Immediate postoperative period up to 12 hours after surgery

  46. Urinary catheterisation

    (YES/NO)

    Measured: Immediate postoperative period up to 12 hours after surgery

  47. Use of respiratory incentive

    (YES/NO)

    Measured: The first day after surgery

  48. 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

    Measured: The first, second and third day after surgery

  49. Morbidity/complications

    (YES/NO)

    Measured: The fourth day after surgery

  50. Days from post-operative period to discharge

    Days

    Measured: The fourth day after surgery

  51. Emergency attendance in the first 30 days from discharge

    (YES/NO)

    Measured: 8 weeks after discharge

  52. Re-admission in General and Digestive Surgery Department

    (YES/NO)

    Measured: 8 weeks after discharge

  53. Re-intervention during re-admission

    (YES/NO)

    Measured: 8 weeks after discharge

  54. Average daily steps

    Measured: 8 weeks after discharge

  55. Adverse events during exercise

    Dizziness, pain, dyspnoea

    Measured: From enrollment to the end of intervention at 8 weeks

  56. Compliance with exercise programme.

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

    Measured: 8 weeks after discharge

  57. EuroQol 5D (Quality of Life Questionnaire)

    Quality of Life Questionnaire. From 0 to 100, where 100 is the best possible health state.

    Measured: From enrollment to the end of intervention at 8 weeks

  58. Suter oral tolerance test

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

    Measured: 8 weeks after discharge

  59. 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

    Measured: In bariatric surgery

  60. Surgical Variable: number of trocars

    Number of trocars

    Measured: In bariatric surgery

  61. 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

    Measured: In bariatric surgery

  62. Surgical Variable: associated surgery

    (YES/NO)

    Measured: In bariatric surgery

  63. Surgical Variable: revision surgery

    (YES/NO)

    Measured: In bariatric surgery

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

    (YES/NO)

    Measured: In bariatric surgery

  65. Surgical Variable: Intraoperative pneumatic compression stockings

    (YES/NO)

    Measured: In bariatric surgery

  66. Surgical Variable: urinary catheterisation

    (YES/NO)

    Measured: In bariatric surgery

  67. Surgical Variable: intra-abdominal drainage

    (YES/NO)

    Measured: In bariatric surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2025
  2. Study start7 May 2025
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06987903
Sponsor's protocol ID
CAPS-OB
Acronym
CAPS-OB
Status last verified
Sep 2026
First submitted
17 Dec 2024
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Pre- and post-operative physical exercise programme and Pre- and post-operative respiratory physiotherapy in people with Bariatric Surgery and Physical Activity and Obesity/Therapy, run by Fundacin Biomedica Galicia Sur at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total weight loss (time frame: From enrollment to the end of intervention at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06987903.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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