Clinical trial NCT03704493: Virtual Group Motivation in Exercise Treadmill Testing
Official title: The Impact of Virtual Group Motivation on the Performance and Comfort of Patients in Exercise Treadmill Testing: A Randomized, Open Label Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Test
Keywords: Exercise testing
coronary artery disease
virtual group motivation
Lead sponsor: Kantonsspital Baden
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* indication for exercise stress testing

Exclusion Criteria:

* any contraindication for exercise stress testing
* unability of performing an exercise treadmill test
* recent surgery

Primary outcomes:
measure: Patients' performance
timeFrame: Day of Exercise Testing
measure: Patients' comfort
timeFrame: Day of Exercise Testing
Secondary outcomes:
measure: Exercise test duration
timeFrame: Day of Exercise Testing
measure: Age predicted heart rate
timeFrame: Day of Exercise Testing
measure: physical limits
timeFrame: Day of Exercise Testing
measure: rate pressure product increase
timeFrame: Day of Exercise Testing
Other outcomes:
Locations:
Study officials:
affiliation: Head of the Department of Internal Medicine
name: Jürg Hans Beer, Prof.
role: STUDY_DIRECTOR
References:
citation: Wilzeck VC, Hufschmid J, Bischof L, Hansi C, Nagele MP, Beer JH, Hufschmid U. A significant increase in exercise test performance with virtual group motivation: a randomised open-label controlled trial. Swiss Med Wkly. 2020 Jul 15;150:w20287. doi: 10.4414/smw.2020.20287. eCollection 2020 Jul 13.