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RecruitingNCT06678360PeriopIPAUpdated Jun 6, 2025

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

An observational study in General Surgery, Perioperative Complication and Perioperative Medicine, sponsored by Karolinska Institutet. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-06.

Sponsored by Karolinska Institutet · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Nov 2024; still recruiting 1 year 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
180,000
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • General Surgery
  • Perioperative Complication
  • Perioperative Medicine
  • Physical Inactivity

Keywords

  • MET-scores
  • Physical activity
  • Perioperative mortality
03

In context

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
180,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Mortality

    Death within the time frames described below

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

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

    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.

    Time frame: 30, 90 and 365 days after index surgery,

Secondary outcomes

  1. Length of stay

    Number of days in the hospital after index surgery

    Time frame: One year after index surgery

07

Study locations

1 of 1 sites recruiting
  • Karolinska Institutet
    Stockholm, Sweden
    Recruiting
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 26, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06678360
Lead sponsor
Karolinska Institutet
Responsible party
Max Bell (MD, PhD, Karolinska Institutet) — Principal investigator
First posted
Nov 7, 2024
Start date
Nov 1, 2024
Primary completion
Aug 31, 2025 (estimated)
Completion
Dec 1, 2025 (estimated)
Last update
Jun 6, 2025

Study contacts

Max Bell, MD, PhD
Contact
max.bell@regionstockholm.se
+46708278533
Arman Valadkhani, MD
Contact
arman.valadkhani@regionstockholm.se
Max Bell, MD, PhD
principal investigator · Karolinska Institutet
Arman Valadkhani, MD
study chair · Karolinska Institutet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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