NCT06678360

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 6, 2025

Status Verified

June 1, 2025

Enrollment Period

10 months

First QC Date

November 5, 2024

Last Update Submit

June 2, 2025

Conditions

Keywords

MET-scoresPhysical activityPerioperative mortality

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Length of stay

    One year after index surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Max Bell, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR
  • Arman Valadkhani, MD

    Karolinska Institutet

    STUDY CHAIR

Central Study Contacts

Arman Valadkhani, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 5, 2024

First Posted

November 7, 2024

Study Start

November 1, 2024

Primary Completion

August 31, 2025

Study Completion

December 1, 2025

Last Updated

June 6, 2025

Record last verified: 2025-06

Locations