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NCT Number: NCT06023069

Preoperative Walking Evaluation and Postoperative Outcome

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?

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Key information

Conditions

General Surgery Perioperative Medicine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital

Stockholm, 171 76, Sweden

Location status: Recruiting

Location contact

Max Birger Bell

CONTACT

[email protected]

+46708278533

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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

Primary outcomes

  1. DAH30 (Days At Home alive at 30 days)

    Time frame: 30 days after index surgery

    DAH30: Patients who are hospitalized for 14 days postoperatively but are alive on day 30 will have DAH30=16. Patients who are hospitalized for five days, then discharged, but return after 10 days for an additional 11-day stay, will have DAH30=14. Anyone who dies within 30 days will have DAH30=0. This outcome measure is validated in several studies and has a significant advantage in that it correlates well with complications, even better than length of stay (LOS)

Secondary outcomes

  1. Mortality

    Time frame: Mortality will be recorded at 30, 60, 90 and 365 days after index surgery

    Death within the time frames described below

Study contacts

Contact information is provided by the study sponsor or research team.

Max Bell, MD, PhD

CONTACT

[email protected]

+46708278533

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Preoperative Walking Evaluation and Postoperative Outcome in Non-cardiac Surgery

Acronym: PREVENT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 5, 2023
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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