## Protocol Section
### Identification Module
**NCT ID:** NCT06413329

**Brief Title:** The Association Between Physical Activity Level and Post-operative Prognosis

**Official Title:** The Association Between Physical Activity Level and Post-operative Prognosis

#### Organization Study ID Info
**ID:** K5803
#### Organization
**Class:** OTHER
**Full Name:** Peking Union Medical College Hospital
### Status Module
#### Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Peking Union Medical College Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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. The correlation between patients' preoperative physical activity level and their surgical outcomes will be explored in this study.

### Conditions Module

**Conditions:**

- Elective Operation Patients

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 324

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients' preoperative exercise level met the standard of American Exercise guidelines.

**Intervention Names:**

- Behavioral: preoperative physical activity level within 3 months

**Label:** exposure

#### Arm Group 2

**Description:** Patients' preoperative exercise level did not meet the standard of American Exercise guidelines

**Label:** control

### Interventions

#### Intervention 1

**Arm Group Labels:**

- exposure

**Description:** 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.

**Name:** preoperative physical activity level within 3 months

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** EQ-5D-3L index will be collected and calculated for evaluation of patients' quality of life after the surgery

**Measure:** Quality of life after the surgery

**Time Frame:** two weeks, one month and three months after surgery

#### Secondary Outcomes

**Description:** from surgery to discharge

**Measure:** postoperative hospitalization days

**Time Frame:** one week after discharge

**Description:** ICU length of stay

**Measure:** ICU length of stay

**Time Frame:** one week after discharge

**Description:** Complications occurring within three months after surgery

**Measure:** postoperative complications

**Time Frame:** three months after surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adult patients undergoing elective surgery at Peking Union Medical College Hospital

Exclusion Criteria:

* 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.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Adult patients undergoing elective surgery at Peking Union Medical College Hospital.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** yuxuerong@pumch.com

**Name:** Xuerong Yu, PHD

**Phone:** +8613651370641

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
