Association of Perioperative Daily Steps and Postoperativ... | NCT04934657

Studies
Association of Perioperative Daily Steps and Postoperative Recovery Among Surgical Patients

NCT04934657

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

Jan 26, 2022Actual

Enrollment

487Estimated

Phase

Not provided

Conditions

Postoperative Recovery

Interventions

no intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 24, 2021Actual

Primary Completion Date

Aug 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Jun 8, 2021

First Submission Date that Met QC Criteria

Jun 21, 2021

First Posted Date

Jun 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2022

Last Update Posted Date

Jan 26, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Walking is the most common, simple and convenient way of exercise with the lowest cost. Studies have shown that daily steps are related to important health outcomes such as cardiovascular events and all-cause mortality. Catrine et al. believe that daily steps can be used as a basic index to evaluate physical fitness. Many observational studies have found that postoperative daily steps collected by wearable devices or smart phones are related to length of hospital stay or even postoperative depression, which is suggested that the average daily steps may be an important index to predict the prognosis of patients.

So the investigators aim to explore the association between peri-operative average daily steps and postoperative recovery of patients scheduled for elective surgery.

Detailed Description

Patients scheduled to undergoing elective surgery including thoracic surgery ,abdominal surgery, primary hip replacement and radical mastectomy will be recruited.The exclusion criteria are as follows: With preoperative unconsciousness; Day surgery (planned length of stay < 1 day); Wheelchair, walking aid or crutch were used before operation; Unable to walk due to physical limitations; The collection time of preoperative steps was less than 1 week; The patient refused to participate.

After recruitment and screening , the investigators will ask the participants to wear a smart band to record data of their daily steps , in addition the investigators will collect the peri-operative data of these participants which includes their rehabilitations and clinical outcomes.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

487Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
normal steps		patients in this group have normal preoperative step counts	Other: no intervention
low steps		patients in this group have low preoperative step counts	Other: no intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention	low steps normal steps

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the length of hospital stay	postoperative length of hospital stay	within 7 days after operation or before discharge, whichever came first

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients scheduled to undergo elective surgery including thoracic surgery abdominal surgery, primary hip replacement and radical mastectomy ; Age≥18 ASA Ⅰ～Ⅲ Able to wear smart band

Exclusion Criteria:

With preoperative unconsciousness Day surgery (planned LOS < 1 day) Wheelchair, walking aid or crutch were used before operation Unable to walk due to physical limitations The collection time of preoperative steps was less than 1 week The patient refused to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

the participants are adult patients scheduled to undergo elective surgery including thoracic surgery ,abdominal surgery, primary hip replacement and radical mastectomy.They will be asked to wear smart band to record their daily steps when they do the preoperative evaluation.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Min Yan, MD	Contact	13757118632		zryanmin@zju.edu.cn

Overall Officials

Name	Affiliation	Role
Min Yan, MD	Second Affiliated Hospital, School of Medicine, Zhejiang University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second Affiliated Hospital of Zhejiang University anesthesiology department	Recruiting	Hangzhou	Zhejiang	310000	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40800130	Derived	Yao Y, Wang Y, Liu Y, Yu Y, Wang X, Wang T, Zheng B, Yan M. Association of perioperative step count tracked by a wristband with surgical outcomes in minimally invasive lung cancer surgery: a prospective observational study. Front Med (Lausanne). 2025 Jul 29;12:1590327. doi: 10.3389/fmed.2025.1590327. eCollection 2025.