Virtual Group Motivation in Exercise Treadmill Testing

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

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.

Study Overview

• Status: Completed
• Conditions: Exercise Test
• Intervention / Treatment: Diagnostic test: Video Group

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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Image Group; The patients were looking at a static image of a lavender flower while exercising on the treadmill.
Experimental: Video Group; The patients were watching a video of a group of amateur runners while exercising on the treadmill.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kantonsspital Baden
• Investigators: Study Director: Jürg Hans Beer, Prof., Head of the Department of Internal Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2014
• Primary Completion (Actual): September 26, 2014
• Study Completion (Actual): September 26, 2014

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (Actual): October 12, 2018

Study Record Updates

• Last Update Posted (Actual): October 12, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: coronary artery disease; Exercise testing; virtual group motivation
• Other Study ID Numbers: ErgoTrial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No