Virtual Group Motivation in Exercise Treadmill Testing

Study Overview
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Brief Summary
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Exercise stress testing is the most frequently used clinical tool for assessment of coronary artery disease. To ensure a high validity of the results, a good Patient compliance is crucial. The aim of this study is to examine the effects of a virtually presented exercise group on the perceived comfort and the exercise capacity of patients during classical treadmill exercise testing. The investigators hypothesis is, that a virtually presented running group will increase the comfort of patients and their exercise capacity.

Detailed Description
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108 Patients were randomized in an open label trial 1:1 to either exercise treadmill testing while watching a static image of a flower (image group) or to exercise treadmill testing while watching a video of 5 amateur runners, running across and fields, giving the patient the impression of running within the group (video group). After the exercise test patients were asked to score their perceived comfort level and achieved level of their subjective physical limit on a 10 point scale. Standard exercise treadmill parameters, as well as baseline demographic data were recorded of each patient. Patients with missing data was excluded of the analysis. Statistic analysis was performed with t-test for normally distributed data and Wilcoxon-Mann-Whitney-Test for non-normal data.

Official Title
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The Impact of Virtual Group Motivation on the Performance and Comfort of Patients in Exercise Treadmill Testing: A Randomized, Open Label Trial

Conditions
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Exercise Test

Intervention / Treatment
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* Diagnostic Test: Video Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: indication for exercise stress testing Exclusion Criteria: any contraindication for exercise stress testing unability of performing an exercise treadmill test recent surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The intervention consists of a video shown to the patient while exercising on the treadmill. It shows 5 amateur runners running across woods and fields. The group is film form behind giving the patient the impression of running within the group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Image Group<br>The patients were looking at a static image of a lavender flower while exercising on the treadmill. | |
| Experimental: Video Group<br>The patients were watching a video of a group of amateur runners while exercising on the treadmill. | Diagnostic Test: Video Group<br>* A video of a group of five amateur runners running along woods and fields. The group was filmed from behind to give the patient the impression of running within the group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' performance | Patients' performance in metabolic equivalents percentage of age predicted maximum | Day of Exercise Testing | 
| Patients' comfort | Subjective level of comfort of patient during the exercise test rated on a 10 point scale. Scale ranges from 1 to 10. 10 indicates that the patient felt absolutely comfortable during the test, 1 indicates that the patient did not feel comfortable at all. | Day of Exercise Testing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise test duration | Exercise test duration in min:sec | Day of Exercise Testing | 
| Age predicted heart rate | achieved percentage of age predicted heart rate | Day of Exercise Testing | 
| physical limits | Achieved subjective level of physical limit rated on a 10 point scale. Scale ranges from 1 to 10, 10 indicates that the patient subjectively reached his physical Limit, 1 indicates that the patient did not reach his physical limit at all. The higher the value the more did the patient reach his physical limit (the better the outcome). | Day of Exercise Testing | 
| rate pressure product increase | increase of the rate pressure product during the test | Day of Exercise Testing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise testing, coronary artery disease, virtual group motivation