NCT05668221

Brief Summary

Frailty is a multidimensional syndrome in which multiple small physiological deficits accumulate gradually, resulting in a loss of physiological reserve and adaptability, putting a patient that is exposed to stressor at a higher risk of adverse outcomes. Both pre-frailty and frailty are associated with worse outcomes and higher healthcare costs. With the potential "teachable" moment from the long surgical waiting time in Hong Kong, the effect of a prehabilitation program incorporated into clinical care pathway in high-risk frail patients undergoing elective major surgery were evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 29, 2022

Completed
Last Updated

May 31, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

December 13, 2022

Last Update Submit

May 26, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Recruitment rate

    Number of patients successfully enrolled into prehabilitation program divided by the number of patients attending prehabilitation clinic

    Up to 1 year after the first case recruitment

  • Attrition rate

    Number of patients who dropped out divided by the number of patients enrolled into prehabilitation program

    Through study completion, an average of 18 months after the first recruitment

  • Adherence of patients to prehabilitation program

    Number of patients completed prehabilitation program divided by the number of patients enrolled

    Through study completion, an average of 18 months after the first recruitment

Secondary Outcomes (9)

  • 6-minute walk test distance

    1 year

  • Calculated peak oxygen uptake

    1 year

  • Hand grip strength

    1 year

  • 30 second chair stand test

    1 year

  • Time-up-and-go test

    1 year

  • +4 more secondary outcomes

Interventions

PrehabilitationBEHAVIORAL

Prehabilitation includes exercise prescription, cognitive function assessment and training, nutritional optimisation at least 4 weeks prior to surgery

Eligibility Criteria

Age50 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Local Hong Kong population, usually elderly frail patients with the above criteria, booked for elective major operation and seen at prehabilitation clinic at least 4 weeks prior to procedure

You may qualify if:

  • Procedure-specific: major hepatectomy (resection of 3 or more Couimaud's segments), pancreaticoduodenectomy, esophagectomy and radical cystectomy
  • Patient-specific: age 50 or above, undergoing elective major procedures, together with one of the followings:
  • American Society of Anaesthesiologists physical status score \>=3
  • Pre-frail to moderately frail patients with a Clinical Frailty Scale 3-6 at the time of assessment at prehabilitation clinic
  • minute walk test distance \<400 meters
  • Duke Activity Status Index \<34
  • Malnutritional Screening Tool score \>=2

You may not qualify if:

  • Patients with unstable angina or unstable cardiac syndrome (New York Heart Association Class IV, critical left main coronary disease, hospitalization for arrhythmias, congestive heart failure or acute coronary syndrome before assessment at prehabilitiation clinic)
  • Patients with left ventricular outflow obstruction (severe aortic stenosis, hypertrophic cardiomyopathy)
  • Chronic obstructive pulmonary disease GOLD stage IV
  • Abdominal aortic aneurysm \>8.0cm or suspected dissecting or leaking aortic aneurysm
  • Cognitive deficits unable to comply with study procedures, physical limitations that would prelude rehabilitation and inability to regularly attend prehabilitation sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Wong HMK, Qi D, Ma BHM, Hou PY, Kwong CKW, Lee A; Prehab Study Group. Multidisciplinary prehabilitation to improve frailty and functional capacity in high-risk elective surgical patients: a retrospective pilot study. Perioper Med (Lond). 2024 Jan 23;13(1):6. doi: 10.1186/s13741-024-00359-x.

MeSH Terms

Conditions

Frailty

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Perioperative CarePatient CareTherapeuticsSurgical Procedures, OperativeExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Man Kin Wong

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Honorary Clinical Assistant Professor

Study Record Dates

First Submitted

December 13, 2022

First Posted

December 29, 2022

Study Start

November 1, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

May 31, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

The data will be kept confidential in locked drawers within the principle investigator's office. It can only be assessed by the principle investigator

Locations