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

NCT ID: NCT06678360

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 180000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-12-01

Brief 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.

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.

Conditions

General Surgery; Perioperative Complication; Perioperative Medicine; Physical Inactivity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Max Bell

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Max Bell, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Arman Valadkhani, MD

Role: STUDY_CHAIR

Karolinska Institutet

Locations

Karolinska Institutet

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Max Bell, MD, PhD

Role: CONTACT

max.bell@regionstockholm.se

+46708278533

Arman Valadkhani, MD

Role: CONTACT

arman.valadkhani@regionstockholm.se

Facility Contacts

Max Bell, MD, PhD

Role: primary

max.bell@regionstockholm.se

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PeriopIPA Karolinska

Identifier Type: -

Identifier Source: org_study_id