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NCT Number: NCT06678360

Perioperative Impact of Physical Activity on Short- and Long-term Morbidity and Mortality

Over 300 million surgeries are performed globally every year. Complications after surgery - infections, cardiovascular conditions, postoperative pulmonary complications and renal impairment - affect survival and quality of life.

Age and co-morbidity are unmodifiable factors, contributing to increased risk of these perioperative complications. However, a modifiable risk factor is physical activity. This study aims to test if self reported physical activity is associated to lower risk of perioperative morbidity and mortality.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska Institutet

Stockholm, Sweden

Location status: Recruiting

Location contact

Max Bell, MD, PhD

CONTACT

[email protected]

Max Bell, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

Research question: This cohort study investigates if higher levels of self reported physical activity at preoperative assessment is associated to lower risk of complications and lower mortality.

Background: Previous studies of perioperative outcomes in high-income countries indicate that close to 20% had complications within 30 days after surgery, and that around 3% died within 1 yr after surgery. In multiple studies, postoperative complications massively increase risk of 1yr mortality. Whilst perioperative complications are under-reported, they affect length of stay and days at home up to 30 days after surgery (DAH30). DAH30 is a validated, patient-centered outcome measure with prognostic importance due to high sensitivity to changes in surgical risks and the impact of surgical complications.

Data collection: Age, sex, body mass index, co-morbid conditions (using ICD-codes and reported medication) as well as American Society of Anesthesiologists (ASA) physical status classification will be recorded. Exposure: the Metabolic Equivalent of Task Score (MET-score), reported in the electronic health record by the attending anesthesiologist based on patient history in conjunction with the preoperative assessment.

Analysis: The MET-score is the exposure/the dependent variable and the other factors will be used in multivariable analyses.

Who can participate

Healthy volunteers accepted: No

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 at the two study sites, Karolinska University Hospital Solna and Karolinska University Hospital Huddinge

Exclusion criteria

Patients under the age of 18, transplant, day surgery, acute surgery, anesthesia monitoring, brachy therapy and gamma knife interventions. In case of multiple surgeries, only the first will be included.

Treatment and study plan

Primary 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

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

    Time frame: 30, 90 and 365 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).

    We will further record DAH90 and DAH365, calculated as described above.

Secondary outcomes

  1. Length of stay

    Time frame: One year after index surgery

    Number of days in the hospital after index surgery

Study contacts

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

Arman Valadkhani, MD

CONTACT

[email protected]

Max Bell, MD, PhD

CONTACT

[email protected]

+46708278533

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Perioperative Impact After Non-cardiac Surgery of Physical Activity on Short- and Long-term Morbidity and Mortality

Acronym: PeriopIPA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 7, 2024
Registry last updated
Jun 6, 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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