Impact of Pt Knowledge on TM Performance

The Impact of Patient Knowledge on Treadmill Performance

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

Study Overview

• Status: Completed
• Conditions: Cardiac Rehabilitation; Stress Testing
• Intervention / Treatment: Other: Education; Other: Control

Detailed Description

Cardiac rehabilitation (CR) is a class 1 or "strong" recommendation in contemporary clinical practice guidelines following percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) after a myocardial infarction (MI)[1-6]. The CR program at St. Joseph's Hospital is a 6 month intensive program focusing on education, exercise and lifestyle changes [7, 8] with the goal of helping the patient improve their functional capacity. The Canadian Cardiovascular Society has set a benchmark of a 0.5 MET increase in functional capacity as one of 5 Quality Indicators (QIs) of CR programs [7, 8]. Quality indicators seek to quantify the quality of CR in a well-defined and evidence based manner. To measure the improvement in functional capacity, CR participants complete an exercise stress test at intake to and exit from the CR program. The improvement on this test is one of the main outcomes of a CR program while illustrating the impact of the CR program on the individual.

Performance on the exercise stress test can be used to predict coronary heart disease and all-cause mortality risk levels in patients [9]. Patients with higher aerobic fitness have a favourable cardiovascular risk factor profile [9]. Obtaining an accurate measure of the patient's fitness levels during the exit stress test is essential to creating an appropriate future care plan. In order to optimize results on the exit stress test, the other contributing factors to performance must be optimized as well.

Past studies suggest that patients may exercise at a lower metabolic intensity without feedback [10]. This result shows the potential increase in performance on the exercise stress test if patients are given feedback. Given that participant feedback, knowledge of results and motivation can all have an effect on performance, we are interested to see if providing additional information to our patients about their performance on their previous (intake) stress test will have an impact on their performance at the exit test.

When the patient learns about their previous performance, they will be better informed of their capacity and should be inclined to improve results at their exit test. If the other contributing factors surrounding one's performance on the treadmill are optimized, the cardiac care team will have a better understanding of the patient's true fitness. This will help the team propose an accurate plan for the future direction of the patient's care

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • St Joseph's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Education; 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; Same
Sham Comparator: Control; 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; Same

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Neville Suskin, MbCHb, St Joseph's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2019
• Primary Completion (Actual): August 30, 2021
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: December 13, 2018
• First Submitted That Met QC Criteria: February 22, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Education; Cardiac Rehabilitation; Stress Testing
• Other Study ID Numbers: REB112887

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No