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

Обзор

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.

Вмешательства

• Процедура Pre- and post-operative physical exercise programme
  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 o
• Процедура Pre- and post-operative respiratory physiotherapy
  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 t

Первичные конечные точки

• Total weight loss [Срок оценки: From enrollment to the end of intervention at 8 weeks]
• Waist circumference [Срок оценки: From enrollment to the end of intervention at 8 weeks]
• Sex (at birth) [Срок оценки: Once at the inclusion]

Вторичные конечные точки (12)

• Comorbidities [Срок оценки: 4 weeks before bariatric surgery]
• Age [Срок оценки: 4 weeks before bariatric surgery]
• Concomitant medication [Срок оценки: 4 weeks before bariatric surgery]
• Active smoking [Срок оценки: 4 weeks before bariatric surgery]
• Alcohol consumption [Срок оценки: 4 weeks before bariatric surgery]
• Previous abdominal surgeries [Срок оценки: 4 weeks before bariatric surgery]
• Previous bariatric interventions [Срок оценки: 4 weeks before bariatric surgery]
• Weight at inclusion [Срок оценки: 4 weeks before bariatric surgery]
• Height at inclusion [Срок оценки: 4 weeks before bariatric surgery]
• Impedanciometry [Срок оценки: 4 weeks before bariatric surgery]
• ASA Score [Срок оценки: 4 weeks before bariatric surgery]
• Baseline O2 Saturation [Срок оценки: 4 weeks before bariatric surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Испания · 1 центр

• Hospital Alvaro Cunqueiro — Vigo

Идентификаторы

NCT: NCT06987903 · CAPS-OB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗