Postoperative Pain, AcuteNCT06222151
Recovering From Bariatric Surgery: the Effects of Early Initiated and Supervised Mobilization
A study testing Intervention 1: Mobilization during hospitalization and Intervention 2: Mobilization the first 4 postoperative weeks in people with Postoperative Pain, Acute and Postoperative Pain, Chronic, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Pain, Acute, Postoperative Pain, Chronic, Bariatric Surgery
- What is being tested?
- Intervention 1: Mobilization during hospitalization and Intervention 2: Mobilization the first 4 postoperative weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Apr 2024to 26 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The ability to read and understand the Danish language
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Esbjerg Hospital, University Hospital of Southern Denmark
Esbjerg, Region Syddanmark, 6700
Nanna Marie Christiansen, +45 20670937, nanna.marie.christiansen2@rsyd.dk
Bibi Gram, +45 79182356, bgram@health.sdu.dk
About this study
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.
Read the detailed description
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.
- Conditions
- Postoperative Pain, Acute, Postoperative Pain, Chronic, Bariatric Surgery, Mobilization, Physical Activity
- Being tested
- Intervention 1: Mobilization during hospitalization, Intervention 2: Mobilization the first 4 postoperative weeks, Control group
- Keywords
- Pain Coping, Bariatric Surgery, Postoperative Pain, Physical Activity, Mobilization
- Medical subject headings
- Pain, Postoperative, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1: Mobilization during hospitalizationOther
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 weeksOther
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 groupOther
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 group | Role | What they receive |
|---|---|---|
| A | Experimental | Participates in intervention 1 and 2 Receives: Other: Intervention 1: Mobilization during hospitalization; Other: Intervention 2: Mobilization the first 4 postoperative weeks |
| B | Other | Participates in intervention 1, control in intervention 2 Receives: Other: Intervention 1: Mobilization during hospitalization; Other: Intervention 2: Mobilization the first 4 postoperative weeks; Other: Control group |
| C | Other | Participates in intervention 2, control in intervention 1 Receives: Other: Intervention 1: Mobilization during hospitalization; Other: Intervention 2: Mobilization the first 4 postoperative weeks; Other: Control group |
| D | Active comparator | Control in both intervention 1 and 2 Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal pain
Abdominal pain measured using a visual analog scale (VAS) of 0-10. A higher score indicates a worse pain.
Measured: 24 hours post surgery
Physical function
A 6 minute walk test measured in metres
Measured: Baseline, 1 month postoperative and 6 months postoperative
Secondary outcomes (9)
Abdominal pain
Abdominal pain measured using a visual analog scale (VAS) of 0-10. A higher score indicates a worse pain.
Measured: At baseline, during intervention 1, 1 month postoperative and 6 months postoperative
Morphine equivalent consumption
Measured in milligram intravenous
Measured: At baseline, during intervention 1, at discharge (at the end of intervention 1), 1 month postoperative and 6 months postoperative
Patient reported pain experiences
APS-POQ-R-D questionnaire.
Measured: At baseline, during intervention 1, 1 month postoperative and 6 months postoperative
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.
Measured: At baseline, during intervention 1, 1 month postoperative and 6 months postoperative
Pain catastrophizing
Pain Catastrophizing Scale questionnaire. Pain Catastrophizing is measured on a score of 0-52. A higher score indicates a higher pain catastrophizing.
Measured: At baseline, during intervention 1, 1 month postoperative and 6 months postoperative
Postoperative nausea and vomiting
On a visual analog scale (VAS) of 0-10. A higher score indicates worse nausea.
Measured: During intervention 1, at discharge (at the end of intervention 1), 1 month postoperative and 6 months postoperative
Health related quality of life (SF-36)
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.
Measured: At baseline, during intervention 1, 1 month postoperative and 6 months postoperative
Physical activity
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
Measured: At baseline, 1 month postoperative and 6 months postoperative
Readmission
Readmissions during study period
Measured: 1 month postoperative and 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start22 Apr 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion26 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be randomized into the intervention or control group. To assess the effect of the two interventions separately and independent of each other and to avoid inequality at the starting point of intervention 1 and 2, the patients will at the starting point be randomized into four different groups: A) Intervention 1/Intervention 2, B) Intervention 1/Control 2, C) Control 1/ Intervention 2 D) Control 1/Control 2 (Figure 1). This procedure will enable evaluation of one intervention group versus one control group who are different at each time point.
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222151
- Sponsor's protocol ID
- 23/44737
- Status last verified
- May 2026
- First submitted
- 13 Dec 2023
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Christiansen NMN, Oxlund J, Dreyer P, Gram B. Recovery After Bariatric Surgery: The effects of Mobilization-A Study Protocol. Pain Manag Nurs. 2026 Jun;27(3):e486-e492. doi: 10.1016/j.pmn.2025.11.017. Epub 2025 Dec 19.
PubMed 41421861
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovering From Bariatric Surgery: the Effects of Early Initiated and Supervised Mobilization
- ClinicalTrials.gov ID
- NCT06222151
- Acronym / sponsor ID
- 23/44737
- Conditions
- Postoperative Pain, Acute, Postoperative Pain, Chronic, Bariatric Surgery, Mobilization, Physical Activity
- Keywords
- Pain Coping, Bariatric Surgery, Postoperative Pain, Physical Activity, Mobilization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 26 Dec 2027 (estimated)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The patients will be randomized into the intervention or control group. To assess the effect of the two interventions separately and independent of each other and to avoid inequality at the starting point of intervention 1 and 2, the patients will at the starting point be randomized into four different groups: A) Intervention 1/Intervention 2, B) Intervention 1/Control 2, C) Control 1/ Intervention 2 D) Control 1/Control 2 (Figure 1). This procedure will enable evaluation of one intervention group versus one control group who are different at each time point.
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: Intervention 1: Mobilization during hospitalization, Other: Intervention 2: Mobilization the first 4 postoperative weeksParticipates in intervention 1 and 2 |
| B | Other | Other: Intervention 1: Mobilization during hospitalization, Other: Intervention 2: Mobilization the first 4 postoperative weeks, Other: Control groupParticipates in intervention 1, control in intervention 2 |
| C | Other | Other: Intervention 1: Mobilization during hospitalization, Other: Intervention 2: Mobilization the first 4 postoperative weeks, Other: Control groupParticipates in intervention 2, control in intervention 1 |
| D | Active comparator | Other: Control groupControl in both intervention 1 and 2 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The ability to read and understand the Danish language
Key exclusion criteria (6 listed)
- Preoperative dependence of walking aids
- Vision impairment
- Previous syncopes or epilepsy
- Admission to the intensive care unit after surgery
- Acute complications during hospital admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention 1: Mobilization during hospitalizationSurgical 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. | Other | A, B, C |
| Intervention 2: Mobilization the first 4 postoperative weeksIntervention 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. | Other | A, B, C |
| Control groupThe 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. | Other | B, C, D |
Primary outcome
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.
Physical function
Time frame: Baseline, 1 month postoperative and 6 months postoperative
A 6 minute walk test measured in metres
9 secondary outcomes
Abdominal pain
Time frame: At baseline, during intervention 1, 1 month postoperative and 6 months postoperative
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
Patient reported pain experiences
Time frame: At baseline, during intervention 1, 1 month postoperative and 6 months postoperative
Pain self-efficacy
Time frame: At baseline, during intervention 1, 1 month postoperative and 6 months postoperative
Pain catastrophizing
Time frame: At baseline, during intervention 1, 1 month postoperative and 6 months postoperative
Postoperative nausea and vomiting
Time frame: During intervention 1, at discharge (at the end of intervention 1), 1 month postoperative and 6 months postoperative
Health related quality of life (SF-36)
Time frame: At baseline, during intervention 1, 1 month postoperative and 6 months postoperative
Physical activity
Time frame: At baseline, 1 month postoperative and 6 months postoperative
Readmission
Time frame: 1 month postoperative and 6 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Derived from this study: PubMed 41421861Christiansen NMN, Oxlund J, Dreyer P, Gram B. Recovery After Bariatric Surgery: The effects of Mobilization-A Study Protocol. Pain Manag Nurs. 2026 Jun;27(3):e486-e492. doi: 10.1016/j.pmn.2025.11.017. Epub 2025 Dec 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1: Mobilization during hospitalization and Intervention 2: Mobilization the first 4 postoperative weeks in people with Postoperative Pain, Acute and Postoperative Pain, Chronic, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nanna Marie Christiansen (+45 20670937, nanna.marie.christiansen2@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal pain (time frame: 24 hours post surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06222151, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.