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Recruiting Not applicable

Recovering From Bariatric Surgery: the Effects of Early Initiated and Supervised Mobilization

NCT06222151 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2024-04-22
Last updated
2026-05-20

Condition(s) studied

Postoperative Pain, AcutePostoperative Pain, ChronicBariatric SurgeryMobilizationPhysical Activity

Investigational drug(s) / intervention(s)

Intervention 1: Mobilization during hospitalizationIntervention 2: Mobilization the first 4 postoperative weeksControl group

Intervention 1: Mobilization during hospitalization: Surgical ICU Optimal Mobilization Score (SOMS) will be used to initiate early mobilization. SOMS consists of five levels of mobilization reaching from no activity to ambulation. Thirty minutes after PACU-arrival, the patient will be asked to do lower leg exercises. If this is possible, the patient will advance to the next level of mobilization. If not possible, level zero is recorded and the patient rests for another 30 minutes before attempting level one again. This continues until the patient succeeds with level four. Safety criteria for advancing to the next level of mobilization are based on criteria for mobilizing patients in the ICU. The intervention group will receive standard care with additional supervised mobilization while hospitalized. This mobilization consist of walking 1000 steps on postoperative day (POD) 0 and 500 steps on POD1 before discharge. Step counts are measured using pedometers.

Intervention 2: Mobilization the first 4 postoperative weeks: Intervention 2 will start the first weekday after discharge and continue for 4 weeks. Four supervised physical activity sessions and 8 sessions using telerehabilitation. The activities are low-intensity exercises (walking and lightly strength training using resistance bands) with progressed intensity throughout the weeks. The exercises will be individually progressed to meet the participant's level of activity, as it is important the participants benefit as much as possible from the intervention. The participants will receive information about different possibilities for leisure activities, for motivation to continue physical activity after the first 4 weeks.

Control group: The control group receives standard care. Patients are mobilized to sit at the bedside before being transferred to the surgical ward. However, it is not used as prophylactic pain management nor is there a structured evidence based protocol with regard to mobilization. The control group will also be equipped with pedometers. They are encouraged to mobilize, and they receive a form in which they can write down mobilization for each hour. There is no planned supervised mobilization. As patients in the control group are assigned to standard care, they will not receive any supervised physical activity after discharge.

Study summary

The aim is to investigate the effect of early initiated and supervised mobilization continued after discharge as management of postoperative pain and recovery following obesity surgery, including patient experiences, pain coping, physical functionality and quality of life.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * The ability to read and understand the Danish language Exclusion Criteria: * Preoperative dependence of walking aids * Vision impairment * Previous syncopes or epilepsy * Admission to the intensive care unit after surgery * Acute complications during hospital admission * Patients are excluded at baseline if they have an oxygen saturation below 90% or a systolic blood pressure above 180 mmHg

Primary outcome measure(s)

  • Abdominal pain — 24 hours post surgery
    Abdominal pain measured using a visual analog scale (VAS) of 0-10. A higher score indicates a worse pain.
  • Physical function — Baseline, 1 month postoperative and 6 months postoperative
    A 6 minute walk test measured in metres

Trial sites (1)

FacilityCityRegionStatus
Esbjerg Hospital, University Hospital of Southern Denmark Esbjerg Region Syddanmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06222151 on ClinicalTrials.gov ↗ ← All trials in Denmark