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

Modulex

Status: Enrolling

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

Treatments: Other: Control group; Other: Intervention 1: Mobilization during hospitalization; Other: Intervention 2: Mobilization the first 4 postoperative weeks

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06222151

23/44737

Details and patient eligibility

About

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.

Full description

Study aims;

1. To investigate the effect of mobilization as pain management following obesity surgery.
2. 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.
3. 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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 4 patient groups

A

Experimental group

Description:

Participates in intervention 1 and 2

Treatment:

Other: Intervention 2: Mobilization the first 4 postoperative weeks

Other: Intervention 1: Mobilization during hospitalization

B

Other group

Description:

Participates in intervention 1, control in intervention 2

Treatment:

Other: Intervention 2: Mobilization the first 4 postoperative weeks

Other: Intervention 1: Mobilization during hospitalization

Other: Control group

C

Other group

Description:

Participates in intervention 2, control in intervention 1

Treatment:

Other: Intervention 2: Mobilization the first 4 postoperative weeks

Other: Intervention 1: Mobilization during hospitalization

Other: Control group

D

Active Comparator group

Description:

Control in both intervention 1 and 2

Treatment:

Other: Control group