Clinical trial NCT06222151: Recovering From Bariatric Surgery: the Effects of Early Initiated and Supervised Mobilization
Official title: Recovering From Bariatric Surgery: the Effects of Early Initiated and Supervised Mobilization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain, Acute
Postoperative Pain, Chronic
Bariatric Surgery
Mobilization
Physical Activity
Keywords: Pain Coping
Bariatric Surgery
Postoperative Pain
Physical Activity
Mobilization
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2024-01-24
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Abdominal pain
timeFrame: 24 hours post surgery
measure: Physical function
timeFrame: Baseline, 1 month postoperative and 6 months postoperative
Secondary outcomes:
measure: Abdominal pain
timeFrame: At baseline, during intervention 1, 1 month postoperative and 6 months postoperative
measure: Morphine equivalent consumption
timeFrame: At baseline, during intervention 1, at discharge (at the end of intervention 1), 1 month postoperative and 6 months postoperative
measure: Patient reported pain experiences
timeFrame: At baseline, during intervention 1, 1 month postoperative and 6 months postoperative
measure: Pain self-efficacy
timeFrame: At baseline, during intervention 1, 1 month postoperative and 6 months postoperative
measure: Pain catastrophizing
timeFrame: At baseline, during intervention 1, 1 month postoperative and 6 months postoperative
measure: Postoperative nausea and vomiting
timeFrame: During intervention 1, at discharge (at the end of intervention 1), 1 month postoperative and 6 months postoperative
measure: Health related quality of life (SF-36)
timeFrame: At baseline, during intervention 1, 1 month postoperative and 6 months postoperative
measure: Physical activity
timeFrame: At baseline, 1 month postoperative and 6 months postoperative
measure: Readmission
timeFrame: 1 month postoperative and 6 months postoperative
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Esbjerg Hospital, University Hospital of Southern Denmark
state: Region Of Southern Denmark
Study officials:
References: