E66
Conditions
Interventions
Group 1: Group A with Standard-Care: receives the usual multimodal concept containing nutritional-, movement- and behavioral therapy, which starts six months prior to bariatric surgery.
Group 2: Group
Sponsors
Chirurgische Klinik der Universitätsklinik Mannheim
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients aged =18 years Planned bariatric surgery within a multimodal treatment program Sufficient communication skills and proficiency in German (or English, if applicable)
Exclusion criteria
Exclusion criteria: 1.Regular participation in mindfulness-based movement therapies such as Tai Chi, yoga, or comparable practices within the past 6 months 2.Relevant psychiatric disorders (e.g., borderline personality disorder with risk of self-harm, moderate to severe depression, post-traumatic stress disorder) 3.Neurological conditions (e.g., history of stroke, polyneuropathy) 4.Limited physical mobility preventing participation in light exercise 5.Cognitive impairment or language barriers that interfere with understanding the exercises or instructions 6.Chronic pain syndromes requiring ongoing significant pharmacological treatment 7.Current relevant substance abuse (e.g., alcohol, opioids)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is to assess the effect of Qigong-based mindfulness exercises, in addition to a multimodal treatment approach, on body weight in patients eligible for bariatric surgery. Efficacy will be evaluated based on the change in body mass index (BMI) between baseline (visit 1) and the preoperative assessment (visit 3). | — |
Secondary
| Measure | Time frame |
|---|---|
| Additionally, the following parameters will be assessed to allow for a more differentiated evaluation of physical changes: body fat percentage (BF%), waist circumference, hip circumference, and quality of life (QoL). Furthermore, adherence to the Qigong intervention (participation in group sessions) and individual practice (frequency of daily meditation) will be documented. a) Continuous monitoring via wearables: To track movement, heart rate, heart rate variability (HRV), sleep quality/duration, respiratory rate, and calorie burn. b) Stress and inflammatory markers: Measurement of serum cortisol, IL-6, IL-1ß, IL-10, TNF-a, and complete blood count at visit 1 (baseline), visit 2 (3 months), visit 3 (preoperative), postoperative day 1 and/or 2, and at the 30-day follow-up. c) Intraoperative opioid and anesthetic consumption: Collected from the anesthesia record on the day of surgery (visit 4). d) Postoperative pain intensity: Assessed using the Visual Analog Scale (VAS) and the Brief Pain Inventory (BPI) on postoperative days 1 and 2. e) Opioid equivalent doses: Quantification of analgesic consumption during hospitalization and at discharge. f) Pulmonary function tests: Performed on postoperative days 1 and 2 to assess pulmonary recovery. g) Sleep quality: Evaluated using the Insomnia Severity Index (ISI) on postoperative days 1 and 2 and at the 30-day follow-up. h) Perceived stress: Assessed using the Perceived Stress Scale (PSS) on postoperative days 1 and 2 and at the 30-day follow-up. i) Quality of recovery (QoR-40): Assessment of postoperative recovery quality during hospitalization. Both the total score (range 40–200) and subdomains (emotional state, physical comfort, psychological support, physical independence, and pain) will be analyzed. j) Overall postoperative morbidity: Documentation of all complications occurring during hospitalization. k) Time to first bowel movement: Recorded in postoperative days as a marker of gastrointestinal | — |
Countries
Germany
Contacts
Public ContactErfan Ghanad
Universitätsklinikum Mannheim
Outcome results
None listed