Preoperative Walking Evaluation and Postoperative Outcome

NCT06023069 | Recruiting

• 1 other identifier: N32276 PMI/Karolinska
• Study Type: observational
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis is that physical activity is associated with a reduced risk of complications and death after surgery. Self-reporting of physical activity is prone to be unreliable. In order to obtain a better picture of patients' physical activity, we intend to investigate the association between the average number of steps and postoperative outcomes. Many other objective measures of physical activity are costly and time-consuming to perform; for example, exercise tests, extensive sampling, and longer questionnaires. The primary research question is: Do patients with a higher degree of physical activity, measured as the average number of steps recorded on the patient's mobile phone, have a reduced risk of peri/postoperative complications and death, measured as Days At Home alive at 30 days (DAH30)? Secondary research questions include: Is physical activity, measured as the average number of steps recorded on the patient's mobile phone, linearly linked to DAH30? Is physical activity, measured as the average number of steps recorded on the patient's mobile phone, associated with specific peri/postoperative organ impact, such as lung, heart, cerebral, infection, or kidney complications? Is physical activity, measured as the average number of steps recorded on the patient's mobile phone, also linked to long-term outcomes one year after surgery? Is physical activity, measured as the average number of steps recorded on the patient's mobile phone, solely associated with DAH30 and organ complications for specific patient groups in terms of age, comorbidities, and/or type of surgery?

Conditions

General Surgery; Perioperative Medicine

Outcome Measures

Primary Outcomes (1)

• 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)

  30 days after index surgery

Secondary Outcomes (1)

• Mortality

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

Interventions

Number of steps recorded by mobile phone as a proxy for physical activity OTHER

This cohort is likely to have patients with many steps/day (high activity) and few steps/day (low activity)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: 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 providing informed consent

You may not qualify if:

• Patients that can not provide informed consent.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 171 76, Sweden

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Max Bell

  N32276 PMI/Karolinska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Max Bell, MD, PhD

CONTACT

+46708278533; max.bell@regionstockholm.se

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: August 28, 2023
• First Posted: September 5, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

SE (1)