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NCT Number: NCT06222151

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Study aims;

  • To investigate the effect of mobilization as pain management following obesity surgery.
  • To investigate patient experiences with mobilization and postoperative pain, including the influence of mobilization on patients' ability to cope with pain and an identification of facilitating factors and barriers towards early mobilization.
  • To assess the effect of mobilization on postoperative recovery, including the general physical activity level, physical function, and quality of life among patients discharged after obesity surgery.

The PhD study consists of two sub-studies. Study 1: Effect of early mobilization as pain management in patients recovering from obesity surgery. The study is a single center randomized controlled trial (RCT). Participants will be randomized with an allocation ratio of 1:1.

Study 2: Patient experiences with early mobilization and postoperative pain after surgery - An interview study Patients participating in both interventions (group A), will be invited to participate in two individual semi structured interviews.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention 1: Mobilization during hospitalization

Other

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 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

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.

Primary outcomes

  1. Abdominal pain

    Time frame: 24 hours post surgery

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

  2. Physical function

    Time frame: Baseline, 1 month postoperative and 6 months postoperative

    A 6 minute walk test measured in metres

Secondary outcomes

  1. Abdominal pain

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

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

  2. Morphine equivalent consumption

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

    Measured in milligram intravenous

  3. Patient reported pain experiences

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

    APS-POQ-R-D questionnaire.

  4. Pain self-efficacy

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

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

  5. Pain catastrophizing

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

    Pain Catastrophizing Scale questionnaire. Pain Catastrophizing is measured on a score of 0-52. A higher score indicates a higher pain catastrophizing.

  6. Postoperative nausea and vomiting

    Time frame: During intervention 1, at discharge (at the end of intervention 1), 1 month postoperative and 6 months postoperative

    On a visual analog scale (VAS) of 0-10. A higher score indicates worse nausea.

  7. Health related quality of life (SF-36)

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

    Questionnaire SF-36. Health related quality of life is measured at a scale of 0-100. A higher score indicates a greater quality of life.

  8. Physical activity

    Time frame: At baseline, 1 month postoperative and 6 months postoperative

    Measured using accelerometers - minutes low/medium/high activity performed per hour. Measured for 7 days at baseline, 7 days 1 month postoperative and 7 days 7 months postoperative

  9. Readmission

    Time frame: 1 month postoperative and 6 months postoperative

    Readmissions during study period

Study contacts

Contact information is provided by the study sponsor or research team.

Bibi Gram

CONTACT

[email protected]

+45 79182356

Nanna Marie Christiansen

CONTACT

[email protected]

+45 20670937

Sponsors and collaborators

Lead sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 24, 2024
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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