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

NCT06222151 | Recruiting

• 1 other identifier: 23/44737
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain, Acute; Postoperative Pain, Chronic; Bariatric Surgery; Mobilization; Physical Activity

Keywords

Pain Coping; Bariatric Surgery; Postoperative Pain; Physical Activity; Mobilization

Outcome Measures

Primary Outcomes (2)

• Abdominal pain

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

  24 hours post surgery

• Physical function

  A 6 minute walk test measured in metres

  Baseline, 1 month postoperative and 6 months postoperative

Secondary Outcomes (9)

• Abdominal pain

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

• Morphine equivalent consumption

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

• Patient reported pain experiences

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

• Pain self-efficacy

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

• Pain catastrophizing

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

Study Arms (4)

A

EXPERIMENTAL

Participates in intervention 1 and 2

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

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

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

Other: Control group

Interventions

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.

A; B; C

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.

A; B; C

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.

B; C; D

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The ability to read and understand the Danish language

You may not qualify if:

• 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

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Esbjerg Hospital, University Hospital of Southern Denmark

Esbjerg, Region Syddanmark, 6700, Denmark

RECRUITING

Related Publications (1)

• Christiansen NMN, Oxlund J, Dreyer P, Gram B. Recovery After Bariatric Surgery: The effects of Mobilization-A Study Protocol. Pain Manag Nurs. 2025 Dec 19:S1524-9042(25)00332-7. doi: 10.1016/j.pmn.2025.11.017. Online ahead of print.

  PMID: 41421861 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Nanna Marie Christiansen

CONTACT

+45 20670937; nanna.marie.christiansen2@rsyd.dk

Bibi Gram

CONTACT

+45 79182356; bgram@health.sdu.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 24, 2024
• Study Start: April 22, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)