Impact of Pt Knowledge on TM Performance

NCT ID: NCT03852875

Last Updated: 2023-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-15
• Study Completion Date: 2022-08-30

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

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

Conditions

Cardiac Rehabilitation; Stress Testing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Education

Intervention Type: OTHER

Same

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.

Group Type: SHAM_COMPARATOR

Control

Intervention Type: OTHER

Same

Interventions

Education

Same

Intervention Type: OTHER

Control

Same

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neville Suskin, MbCHb

Role: PRINCIPAL_INVESTIGATOR

St Joseph's Hospital

Locations

St Joseph's Hospital

London, Ontario, Canada

Countries

Canada

Other Identifiers

REB112887

Identifier Type: -

Identifier Source: org_study_id