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OpenTrials
Completed

NCT Number: NCT03852875

Impact of Pt Knowledge on TM 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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Joseph's Hospital

London, Ontario, N6A 4V2, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education

Other

Same

Control

Other

Same

Primary outcomes

  1. Change in METs

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

    Improvement in Treadmill Performance as expressed in TM-derived METs

  2. Change in VO2peak

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

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

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

The Impact of Patient Knowledge on Treadmill Performance

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Feb 25, 2019
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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