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

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06222151
• Other study ID #: 23/44737
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2024
• Est. completion date: February 1, 2027

Study information

• Verified date: April 2024
• Source: Hospital of South West Jutland
• Contact: Nanna Marie Christiansen
• Phone: +45 20670937
• Email: nanna.marie.christiansen2[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Denmark	Esbjerg Hospital, University Hospital of Southern Denmark	Esbjerg	Region Of Southern Denmark

Sponsors (2)

Lead Sponsor	Collaborator
Hospital of South West Jutland	Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Physical function	A 6 minute walk test measured in metres	Baseline, 1 month postoperative and 6 months postoperative
Secondary	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
Secondary	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
Secondary	Patient reported pain experiences	APS-POQ-R-D questionnaire.	At baseline, during intervention 1, 1 month postoperative and 6 months postoperative
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Readmission	Readmissions during study period	1 month postoperative and 6 months postoperative