Brief Summary

The primary outcome of the Cardiac Rehabilitation (CR) program at St Joseph's Hospital is change in performance on an exercise stress test. Patients complete an exercise stress test when they enter and exit the CR program. An improvement in stress test performance reflects an improvement in physical fitness, but is also associated with better long-term health outcomes (e.g. reducing the chance of having to go back to hospital; lower likelihood of dying). While physical fitness has the strongest impact on stress test performance, other factors can also affect the test result. We expect that informing patients about their baseline stress test result will improve their exit treadmill performance. This intervention may be a simple and cost-effective method of increasing motivation among patients to do their best on the exit test

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

March 15, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

March 17, 2023

Status Verified

March 1, 2023

Enrollment Period

2.5 years

First QC Date

December 13, 2018

Last Update Submit

March 16, 2023

Conditions

Keywords

Cardiac RehabilitationStress TestingEducation

Outcome Measures

Primary Outcomes (2)

  • Change in METs

    Improvement in Treadmill Performance as expressed in TM-derived METs

    Intake assessment is at T=0 (baseline). Exit assessment is at approximately 6 months (exit)

  • Change in VO2peak

    Improvement in Treadmill Performance as measured by metabolic testing (VO2 measurement) during Treadmill test

    Intake assessment is at T=0 (baseline). Exit assessment is at approximately 6 months (exit)

Study Arms (2)

Education

EXPERIMENTAL

Patients in the experimental arm will receive a 1-on-1 education session to review the their CR participation. As part of the discussion about their CR participation, these patients will also receive feedback on their intake exercise stress test.

Other: Education

Control

SHAM COMPARATOR

Patients in the Control arm will receive a 1-on-1 education session to review the their CR participation. As part of the discussion about their CR participation, these patients will NOT receive feedback on their intake exercise stress test.

Other: Control

Interventions

Same

Education
ControlOTHER

Same

Control

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who completing the St Joseph's Hospital CR Program
  • Patients exiting the CR program with available results (ECG and metabolic) from their intake assessment
  • Patients who are able to comprehend the educational intervention at their exit from CR
  • Willing to participate in research and sign informed consent

You may not qualify if:

  • Patients who decline participation
  • CR patients without available results from intake assessment
  • Patients who, based on the clinical judgement of the attending physician, have some transitory health issue (e.g. cold, infection, biomechanical issues) that may impact their performance on the TM test.
  • Patients who are unable to perform the treadmill test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Joseph's Hospital

London, Ontario, N6A 4V2, Canada

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Neville Suskin, MbCHb

    St Joseph's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2018

First Posted

February 25, 2019

Study Start

March 15, 2019

Primary Completion

August 30, 2021

Study Completion

August 30, 2022

Last Updated

March 17, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations