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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-69
SponsorFundacin Biomedica Galicia Sur

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patient's refusal to enter the study.

Inability to comprehend participation in a study.

Urgent interventions.

Patients undergoing combined surgery with another surgical service.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pre- and post-operative physical exercise programme

    Procedure/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 physiotherapy

    Procedure/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.

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: Arm 1Experimental treatment 2 interventions
Group B: Arm 2No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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
2

Waist circumference

Waist circumference measured in cm

Time frame
From enrollment to the end of intervention at 8 weeks
3

Sex (at birth)

Time frame
Once at the inclusion

Secondary outcomes

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.

Time frame
4 weeks before bariatric surgery
2

Age

Age in years

Time frame
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.

Time frame
4 weeks before bariatric surgery
4

Active smoking

Yes/No

Time frame
4 weeks before bariatric surgery

Other outcomes

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