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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03704493
Other study ID # ErgoTrial
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 7, 2014
Est. completion date September 26, 2014

Study information

Verified date October 2018
Source Kantonsspital Baden
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date September 26, 2014
Est. primary completion date September 26, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- indication for exercise stress testing

Exclusion Criteria:

- any contraindication for exercise stress testing

- unability of performing an exercise treadmill test

- recent surgery

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Video Group
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Kantonsspital Baden

Outcome

Type Measure Description Time frame Safety issue
Primary Patients' performance Patients' performance in metabolic equivalents percentage of age predicted maximum Day of Exercise Testing
Primary 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 Exercise test duration Exercise test duration in min:sec Day of Exercise Testing
Secondary Age predicted heart rate achieved percentage of age predicted heart rate Day of Exercise Testing
Secondary 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
Secondary rate pressure product increase increase of the rate pressure product during the test Day of Exercise Testing
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