Elective Operation PatientsNCT06413329
The Association Between Physical Activity Level and Post-operative Prognosis
An observational study of Elective Operation Patients, run by Peking Union Medical College Hospital.
Trial summary
The study primarily focuses on adult patients who underwent elective surgery at Peking Union Medical College Hospital. The physical activity level before surgery within the past 3 months is the main exposure factor and postoperative quality of life score (EQ-5D-3L utility index) is the main outcome indicator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Operation Patients
- What is being tested?
- preoperative physical activity level within 3 months
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 324 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 undergoing elective surgery at Peking Union Medical College Hospital.
Who may be able to join
- Adult patients undergoing elective surgery at Peking Union Medical College Hospital
Who cannot join
- 1. Patients scheduled for surgery with minimal impact on overall health (including eye surgery, abortion, hysteroscopy, conization, gastroscopy, vascular angiography, and superficial surgery, etc.) 2. Orthopedic and cardiac surgery patients 3. Patients who are unable to live independently or have significant limitations in physical activity prior to surgery 4. Patients who have difficulty communicating verbally and cannot complete the questionnaire 5. Pregnant women.
Trial locations and contacts
No sites are listed yet.
About this study
The study primarily focuses on adult patients who underwent elective surgery at Peking Union Medical College Hospital. The physical activity level before surgery within the past 3 months is the main exposure factor and postoperative quality of life score (EQ-5D-3L utility index) is the main outcome indicator. The correlation between patients' preoperative physical activity level and their surgical outcomes will be explored in this study.
- Conditions
- Elective Operation Patients
- Being tested
- preoperative physical activity level within 3 months
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative physical activity level within 3 monthsBehavioural
The exercise compliance criteria are moderate exercise of at least 150 minutes per week or high-intensity exercise of at least 75 minutes per week.
| Study group | Role | What they receive |
|---|---|---|
| exposure | Patients' preoperative exercise level met the standard of American Exercise guidelines. Receives: Behavioral: preoperative physical activity level within 3 months | |
| control | Patients' preoperative exercise level did not meet the standard of American Exercise guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life after the surgery
EQ-5D-3L index will be collected and calculated for evaluation of patients' quality of life after the surgery
Measured: two weeks, one month and three months after surgery
Secondary outcomes (3)
postoperative hospitalization days
from surgery to discharge
Measured: one week after discharge
ICU length of stay
ICU length of stay
Measured: one week after discharge
postoperative complications
Complications occurring within three months after surgery
Measured: three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study startJun 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Operation PatientsStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413329
- Sponsor's protocol ID
- K5803
- Status last verified
- May 2024
- First submitted
- 9 May 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Physical Activity Level and Post-operative Prognosis
- ClinicalTrials.gov ID
- NCT06413329
- Acronym / sponsor ID
- K5803
- Conditions
- Elective Operation Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 May 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.
The study primarily focuses on adult patients who underwent elective surgery at Peking Union Medical College Hospital. The physical activity level before surgery within the past 3 months is the main exposure factor and postoperative quality of life score (EQ-5D-3L utility index) is the main outcome indicator. The correlation between patients' preoperative physical activity level and their surgical outcomes will be explored in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exposure | – | Behavioral: preoperative physical activity level within 3 monthsPatients' preoperative exercise level met the standard of American Exercise guidelines. |
| control | – | –Patients' preoperative exercise level did not meet the standard of American Exercise guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective surgery at Peking Union Medical College Hospital.
Key inclusion criteria (1 listed)
- Adult patients undergoing elective surgery at Peking Union Medical College Hospital
Key exclusion criteria (1 listed)
- 1. Patients scheduled for surgery with minimal impact on overall health (including eye surgery, abortion, hysteroscopy, conization, gastroscopy, vascular angiography, and superficial surgery, etc.) 2. Orthopedic and cardiac surgery patients 3. Patients who are unable to live independently or have significant limitations in physical activity prior to surgery 4. Patients who have difficulty communicating verbally and cannot complete the questionnaire 5. Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preoperative physical activity level within 3 monthsThe exercise compliance criteria are moderate exercise of at least 150 minutes per week or high-intensity exercise of at least 75 minutes per week. | Behavioural | exposure |
Primary outcome
Quality of life after the surgery
Time frame: two weeks, one month and three months after surgery
EQ-5D-3L index will be collected and calculated for evaluation of patients' quality of life after the surgery
3 secondary outcomes
postoperative hospitalization days
Time frame: one week after discharge
ICU length of stay
Time frame: one week after discharge
postoperative complications
Time frame: three months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Elective Operation Patients, run by Peking Union Medical College Hospital.
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: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuerong Yu, PHD (+8613651370641, yuxuerong@pumch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life after the surgery (time frame: two weeks, one month and three months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2024.