Exercise TestNCT03704493
Virtual Group Motivation in Exercise Treadmill Testing
A study testing Video Group in people with Exercise Test, run by Kantonsspital Baden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exercise Test
- What is being tested?
- Video Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 7 Jul 2014to 26 Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- indication for exercise stress testing
Who cannot join
- any contraindication for exercise stress testing
- unability of performing an exercise treadmill test
- recent surgery
About this study
Official title: 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.
Read the 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.
- Conditions
- Exercise Test
- Being tested
- Video Group
- Keywords
- Exercise testing, coronary artery disease, virtual group motivation
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Video Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' performance
Patients' performance in metabolic equivalents percentage of age predicted maximum
Measured: 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.
Measured: Day of Exercise Testing
Secondary outcomes (4)
Exercise test duration
Exercise test duration in min:sec
Measured: Day of Exercise Testing
Age predicted heart rate
achieved percentage of age predicted heart rate
Measured: 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).
Measured: Day of Exercise Testing
rate pressure product increase
increase of the rate pressure product during the test
Measured: Day of Exercise Testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start7 Jul 2014
- Primary completion26 Sep 2014
- Study completion26 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise TestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Baden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Urs Hufschmid, Kantonsspital Baden
- Investigators
- Jürg Hans Beer, Prof., Study director, Head of the Department of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704493
- Sponsor's protocol ID
- ErgoTrial
- Status last verified
- Oct 2018
- First submitted
- 10 Sep 2018
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 32725609
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Virtual Group Motivation on the Performance and Comfort of Patients in Exercise Treadmill Testing: A Randomized, Open Label Trial
- ClinicalTrials.gov ID
- NCT03704493
- Acronym / sponsor ID
- ErgoTrial
- Conditions
- Exercise Test
- Keywords
- Exercise testing, coronary artery disease, virtual group motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Kantonsspital BadenUniversity, hospital or other
- Study start
- 7 Jul 2014 (actual)
- Primary completion
- 26 Sep 2014 (actual)
- Study completion
- 26 Sep 2014 (actual)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Image Group | No intervention | –The patients were looking at a static image of a lavender flower while exercising on the treadmill. |
| Video Group | Experimental | Diagnostic Test: Video GroupThe patients were watching a video of a group of amateur runners while exercising on the treadmill. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- indication for exercise stress testing
Key exclusion criteria (3 listed)
- any contraindication for exercise stress testing
- unability of performing an exercise treadmill test
- recent surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video GroupA 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. | Diagnostic test | Video Group |
Primary outcome
Patients' performance
Time frame: Day of Exercise Testing
Patients' performance in metabolic equivalents percentage of age predicted maximum
Patients' comfort
Time frame: Day of Exercise Testing
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.
4 secondary outcomes
Exercise test duration
Time frame: Day of Exercise Testing
Age predicted heart rate
Time frame: Day of Exercise Testing
physical limits
Time frame: Day of Exercise Testing
rate pressure product increase
Time frame: Day of Exercise Testing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Derived from this study: PubMed 32725609Wilzeck 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jürg Hans Beer, Prof. study director
Head of the Department of Internal Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Video Group in people with Exercise Test, run by Kantonsspital Baden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' performance (time frame: Day of Exercise Testing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03704493, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.