General SurgeryPeriopIPANCT06678360
Perioperative Impact of Physical Activity on Short- and Long-term Morbidity and Mortality
An observational study of General Surgery and Perioperative Complication, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Surgery, Perioperative Complication, Perioperative Medicine
- How many people
- 180,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2024to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (equal to or over 18 years) undergoing elective non-cardiac surgery
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Arman Valadkhani, MD contact
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet
Stockholm
Max Bell, MD, PhD, max.bell@regionstockholm.se
Max Bell, MD, PhD
About this study
Official title: 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.
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.
- Keywords
- MET-scores, Physical activity, Perioperative mortality
- Medical subject headings
- Sedentary Behavior, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death within the time frames described below
Measured: 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.
Measured: 30, 90 and 365 days after index surgery,
Secondary outcomes (1)
Length of stay
Number of days in the hospital after index surgery
Measured: One year after index surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Nov 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for General SurgeryStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Bell, Karolinska Institutet
- Investigators
- Max Bell, MD, PhD, Principal investigator, Karolinska InstitutetArman Valadkhani, MD, Study chair, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678360
- Sponsor's protocol ID
- PeriopIPA Karolinska
- Acronym
- PeriopIPA
- Status last verified
- Jun 2025
- First submitted
- 5 Nov 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Valadkhani A, Sebghati S, Piehl J, Bell M. Impact of Preoperative Functional Capacity on Postoperative Mortality and Morbidity: A Prospective Cohort Study. Anesthesiology. 2026 Mar 1;144(3):525-534. doi: 10.1097/ALN.0000000000005779. Epub 2025 Oct 3.
PubMed 41043174
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Impact After Non-cardiac Surgery of Physical Activity on Short- and Long-term Morbidity and Mortality
- ClinicalTrials.gov ID
- NCT06678360
- Acronym / sponsor ID
- PeriopIPA / PeriopIPA Karolinska
- Keywords
- MET-scores, Physical activity, Perioperative mortality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180,000 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (equal to or over 18 years) undergoing elective non-cardiac surgery
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: Mortality will be recorded at 30, 60, 90 and 365 days after index surgery
Death within the time frames described below
DAH30 (Days At Home alive at 30 days)
Time frame: 30, 90 and 365 days after index surgery,
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.
1 secondary outcome
Length of stay
Time frame: One year after index surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Derived from this study: PubMed 41043174Valadkhani A, Sebghati S, Piehl J, Bell M. Impact of Preoperative Functional Capacity on Postoperative Mortality and Morbidity: A Prospective Cohort Study. Anesthesiology. 2026 Mar 1;144(3):525-534. doi: 10.1097/ALN.0000000000005779. Epub 2025 Oct 3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arman Valadkhani, MD contact
Max Bell, MD, PhD principal investigator
Karolinska Institutet
Arman Valadkhani, MD study chair
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Surgery and Perioperative Complication, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Max Bell, MD, PhD (+46708278533, max.bell@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Mortality will be recorded at 30, 60, 90 and 365 days after index surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06678360, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.