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

Perioperative Impact After Non-cardiac Surgery 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.

Study Overview

• Status: Recruiting
• Conditions: General Surgery; Perioperative Medicine; Physical Inactivity; Perioperative Complication

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.

• Study Type: Observational
• Enrollment (Estimated): 180000

Contacts and Locations

• Study Contact: Name: Max Bell, MD, PhD; Phone Number: +46708278533; Email: max.bell@regionstockholm.se
• Study Contact Backup: Name: Arman Valadkhani, MD; Email: arman.valadkhani@regionstockholm.se

Study Locations

• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Karolinska Institutet
    • Contact: Max Bell, MD, PhD; Email: max.bell@regionstockholm.se
    • Principal Investigator: Max Bell, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Death within the time frames described below	Mortality will be recorded at 30, 60, 90 and 365 days after index surgery
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.	30, 90 and 365 days after index surgery,

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Number of days in the hospital after index surgery	One year after index surgery

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Max Bell, MD, PhD, Karolinska Institutet; Study Chair: Arman Valadkhani, MD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 7, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Physical activity; Perioperative mortality; MET-scores
• Other Study ID Numbers: PeriopIPA Karolinska

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No