Impact of Pt Knowledge on TM Performance

Cardiac Rehabilitation Clinical Trial

Official title:

The Impact of Patient Knowledge on Treadmill Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03852875
• Other study ID #: REB112887
• Status: Completed
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: August 30, 2022

Study information

• Verified date: March 2023
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Rehabilitation
• Stress Testing

Intervention

Other:
• Education
Same
• Control
Same

Locations

Country	Name	City	State
Canada	St Joseph's Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)