NCT07621120

Brief Summary

This single-center prospective cohort study is designed to evaluate whether preoperative physical activity measured by a wearable accelerometer is associated with cardiovascular autonomic function and whether it can help predict post-induction hypotension in elderly patients undergoing elective non-cardiac surgery. Patients aged 65 years or older scheduled for general anesthesia with tracheal intubation will undergo preoperative physical activity monitoring using an ActiGraph wearable accelerometer. Activity-related parameters, including sedentary time, light-, moderate-, and vigorous-intensity activity, daily step count, and sleep duration, will be recorded. Cardiovascular autonomic function will be assessed perioperatively using noninvasive continuous hemodynamic monitoring, with baroreflex sensitivity-related indices derived from continuous blood pressure and beat-to-beat timing data. The primary outcome is post-induction hypotension. Secondary outcomes include early intraoperative hypotension, postoperative complications, and 30-day mortality. This study aims to clarify the relationship between habitual physical activity and autonomic regulation in older surgical patients and to provide evidence supporting future prehabilitation strategies.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 2, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

May 25, 2026

Last Update Submit

June 1, 2026

Conditions

Keywords

post induction hypotensionelderly patientwearable accelerometer

Outcome Measures

Primary Outcomes (2)

  • Post induction hypotension

    Systolic blood pressure less than 90 mmHg, mean arterial pressure less than 65 mmHg, or a decrease of more than 30% from baseline.

    Within 20 minutes after induction of anesthesia or before surgical incision.

  • Early intraoperative hypotension

    Systolic blood pressure less than 90 mmHg, mean arterial pressure less than 65 mmHg, or a decrease of more than 30% from baseline.

    Within 30 minutes after incision

Secondary Outcomes (1)

  • Postoperative complications

    Within 30 days after surgery

Study Arms (1)

observational group

all of enrolled patients

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Elderly patients who will undergo general anesthesia surgery in Peking Union Medical College Hospital.

You may qualify if:

  • Age ≥65 years
  • Scheduled for elective non-cardiac surgery
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Planned to undergo general anesthesia
  • Planned tracheal intubation
  • The patient and family members are able to understand the study protocol, are willing to participate, and provide written informed consent

You may not qualify if:

  • Severe vascular disease
  • Secondary hypertension
  • Limb tremor disorders, such as Parkinson disease
  • Inability to wear a wrist-based wearable accelerometer for any reason
  • Inability to measure upper-extremity blood pressure
  • Atrial fibrillation or other arrhythmias unsuitable for baroreflex sensitivity measurement
  • Mental or psychiatric conditions resulting in inability to cooperate with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (2)

  • Finet M, Bellicha A, Sage E, Glorion M, Kennel T, Labro M, Trillat B, Fischler M, Vallee A, Le Guen M, Fessler J. Comprehensive assessment of postoperative mobility during the first days after mini-invasive lung surgery: A prospective observational study. J Clin Anesth. 2023 Jun;86:111048. doi: 10.1016/j.jclinane.2022.111048. Epub 2023 Jan 28.

    PMID: 36716650BACKGROUND
  • Gardenghi G, Rondon MU, Braga AM, Scanavacca MI, Negrao CE, Sosa E, Hachul DT. The effects of exercise training on arterial baroreflex sensitivity in neurally mediated syncope patients. Eur Heart J. 2007 Nov;28(22):2749-55. doi: 10.1093/eurheartj/ehm208. Epub 2007 Jun 7.

    PMID: 17561494BACKGROUND

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 25, 2026

First Posted

June 2, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

June 2, 2026

Record last verified: 2026-04

Locations