Preoperative Walking Evaluation and Postoperative Outcome

NCT ID: NCT06023069

Last Updated: 2025-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

264 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-12-31

Brief Summary

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The hypothesis is that physical activity is associated with a reduced risk of complications and death after surgery.

Self-reporting of physical activity is prone to be unreliable. In order to obtain a better picture of patients' physical activity, we intend to investigate the association between the average number of steps and postoperative outcomes. Many other objective measures of physical activity are costly and time-consuming to perform; for example, exercise tests, extensive sampling, and longer questionnaires.

The primary research question is: Do patients with a higher degree of physical activity, measured as the average number of steps recorded on the patient's mobile phone, have a reduced risk of peri/postoperative complications and death, measured as Days At Home alive at 30 days (DAH30)?

Secondary research questions include:

Is physical activity, measured as the average number of steps recorded on the patient's mobile phone, linearly linked to DAH30? Is physical activity, measured as the average number of steps recorded on the patient's mobile phone, associated with specific peri/postoperative organ impact, such as lung, heart, cerebral, infection, or kidney complications? Is physical activity, measured as the average number of steps recorded on the patient's mobile phone, also linked to long-term outcomes one year after surgery? Is physical activity, measured as the average number of steps recorded on the patient's mobile phone, solely associated with DAH30 and organ complications for specific patient groups in terms of age, comorbidities, and/or type of surgery?

Detailed Description

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Project Description Method This is a non-interventional prospective observational multicenter study of the association between physical activity and peri/postoperative outcomes, planned to be conducted in two stages. First, as a pilot study involving multiple participating anesthesia/surgery clinics. Following this, the plan is to analyze data from the mentioned pilot study and then launch a global multicenter study on a more defined patient group.

Procedures/Data Collection Preoperatively: The investigators will record age, gender, comorbidities, and ongoing medication, as well as ASA classification, frailty score, and mDASI (modified Duke Activity Status Index), which is a measure of functional ability. Routine preoperative laboratory tests will be noted. Furthermore, the investigators intend to record average physical activity, including daily step count on average at one, six, and twelve months before surgery, based on data from the patient's mobile phone\*. Type of planned surgery will be recorded.

\*The dominant mobile phones on the market (iOS and Android-based) use different types of systems to count steps. Some mobile phones completely lack such systems. The validation of how accurately they count steps per day also varies. We will record the model and operating system, as well as the type of app used. Not all patients carry their phones all the time; we intend to register their own estimate of how often it is carried. A few patients do not have a mobile phone and cannot contribute step per day data.

Intraoperatively: The investigators will record anesthesia method, operation time (incision time and total operation time), fluid balance, bleeding, and transfusion requirements, as well as adverse events such as blood pressure drops, hypoxia, tachycardia.

Conditions

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General Surgery Perioperative Medicine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Number of steps recorded by mobile phone as a proxy for physical activity

This cohort is likely to have patients with many steps/day (high activity) and few steps/day (low activity)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Adult patients (equal to or over 18 years) undergoing elective non-cardiac surgery providing informed consent

Exclusion Criteria

Patients that can not provide informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Max Bell

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Max Bell

Role: PRINCIPAL_INVESTIGATOR

N32276 PMI/Karolinska

Locations

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Karolinska University Hospital

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Max Bell, MD, PhD

Role: CONTACT

+46708278533

Facility Contacts

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Max Birger Bell

Role: primary

+46708278533

Other Identifiers

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N32276 PMI/Karolinska

Identifier Type: -

Identifier Source: org_study_id

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