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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorEsbjerg Hospital - University Hospital of Southern Denmark

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

The ability to read and understand the Danish language

Disqualifiers

Preoperative dependence of walking aids

Vision impairment

Previous syncopes or epilepsy

Admission to the intensive care unit after surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intervention 1: Mobilization during hospitalization

    Other intervention

    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

    Other intervention

    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

    Other intervention

    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.

Treatment groups

112 Participants
are divided into 4 treatment groups
Group A: AExperimental treatment 2 interventions
Group B: BOther 3 interventions
Group C: COther 3 interventions
Group D: DActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Abdominal pain

Abdominal pain measured using a visual analog scale (VAS) of 0-10. A higher score indicates a worse pain.

Time frame
24 hours post surgery
2

Physical function

A 6 minute walk test measured in metres

Time frame
Baseline, 1 month postoperative and 6 months postoperative

Secondary outcomes

1

Abdominal pain

Abdominal pain measured using a visual analog scale (VAS) of 0-10. A higher score indicates a worse pain.

Time frame
At baseline, during intervention 1, 1 month postoperative and 6 months postoperative
2

Morphine equivalent consumption

Measured in milligram intravenous

Time frame
At baseline, during intervention 1, at discharge (at the end of intervention 1), 1 month postoperative and 6 months postoperative
3

Patient reported pain experiences

APS-POQ-R-D questionnaire.

Time frame
At baseline, during intervention 1, 1 month postoperative and 6 months postoperative
4

Pain self-efficacy

PSEQ-DK questionnaire. Pain self-efficacy is measured on a score of 0-60. A higher score indicates a greater pain self-efficacy.

Time frame
At baseline, during intervention 1, 1 month postoperative and 6 months postoperative

Other outcomes

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