NCT03704493

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2014

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 12, 2018

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

3 months

First QC Date

September 10, 2018

Last Update Submit

October 10, 2018

Conditions

Keywords

Exercise testingcoronary artery diseasevirtual group motivation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Exercise test duration

    Day of Exercise Testing

  • Age predicted heart rate

    Day of Exercise Testing

  • physical limits

    Day of Exercise Testing

  • rate pressure product increase

    Day of Exercise Testing

Study Arms (2)

Image Group

NO INTERVENTION

The patients were looking at a static image of a lavender flower while exercising on the treadmill.

Video Group

EXPERIMENTAL

The patients were watching a video of a group of amateur runners while exercising on the treadmill.

Diagnostic Test: Video Group

Interventions

Video GroupDIAGNOSTIC_TEST

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.

Video Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • indication for exercise stress testing

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Jürg Hans Beer, Prof.

    Head of the Department of Internal Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Cardiology, Principal Investigator

Study Record Dates

First Submitted

September 10, 2018

First Posted

October 12, 2018

Study Start

July 7, 2014

Primary Completion

September 26, 2014

Study Completion

September 26, 2014

Last Updated

October 12, 2018

Record last verified: 2018-10