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.

Study Overview

• Status: Not yet recruiting
• Conditions: Physical Activity; Postoperative Pain, Acute; Postoperative Pain, Chronic; Bariatric Surgery; Mobilization
• Intervention / Treatment: Other: Intervention 1: Mobilization during hospitalization; Other: Intervention 2: Mobilization the first 4 postoperative weeks; Other: Control group

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.

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nanna Marie Christiansen; Phone Number: +45 20670937; Email: nanna.marie.christiansen2@rsyd.dk
• Study Contact Backup: Name: Bibi Gram; Phone Number: +45 79182356; Email: bgram@health.sdu.dk

Study Locations

• Denmark
  • Region Of Southern Denmark
    • Esbjerg, Region Of Southern Denmark, Denmark, 6700
      • Esbjerg Hospital, University Hospital of Southern Denmark
      • Contact: Nanna Marie Christiansen; Phone Number: +45 20670937; Email: nanna.marie.christiansen2@rsyd.dk
      • Contact: Bibi Gram; Phone Number: +45 79182356; Email: bgram@health.sdu.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; Participates in intervention 1 and 2	Other: Intervention 1: Mobilization during hospitalization; 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.; Other: Intervention 2: Mobilization the first 4 postoperative weeks; 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.
Other: B; Participates in intervention 1, control in intervention 2	Other: Intervention 1: Mobilization during hospitalization; 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.; Other: Intervention 2: Mobilization the first 4 postoperative weeks; 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.; Other: Control group; 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.
Other: C; Participates in intervention 2, control in intervention 1	Other: Intervention 1: Mobilization during hospitalization; 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.; Other: Intervention 2: Mobilization the first 4 postoperative weeks; 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.; Other: Control group; 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.
Active Comparator: D; Control in both intervention 1 and 2	Other: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal pain	Abdominal pain measured using a visual analog scale (VAS) of 0-10. A higher score indicates a worse pain.	At baseline, during intervention 1, 1 month postoperative and 6 months postoperative
Morphine equivalent consumption	Measured in milligram intravenous	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.	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.	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.	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.	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.	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	At baseline, 1 month postoperative and 6 months postoperative
Readmission	Readmissions during study period	1 month postoperative and 6 months postoperative

Collaborators and Investigators

• Sponsor: Hospital of South West Jutland
• Collaborators: Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: January 15, 2024
• First Posted (Estimated): January 24, 2024

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Physical Activity; Postoperative Pain; Bariatric Surgery; Mobilization; Pain Coping
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Chronic Pain; Acute Pain
• Other Study ID Numbers: 23/44737

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No