- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03704493
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
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- indication for exercise stress testing
Exclusion Criteria:
- any contraindication for exercise stress testing
- unability of performing an exercise treadmill test
- recent surgery
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Image Group
The patients were looking at a static image of a lavender flower while exercising on the treadmill.
|
|
|
Experimentell: Video Group
The patients were watching a video of a group of amateur runners while exercising on the treadmill.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patients' performance
Tidsram: Day of Exercise Testing
|
Patients' performance in metabolic equivalents percentage of age predicted maximum
|
Day of Exercise Testing
|
|
Patients' comfort
Tidsram: 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.
|
Day of Exercise Testing
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Exercise test duration
Tidsram: Day of Exercise Testing
|
Exercise test duration in min:sec
|
Day of Exercise Testing
|
|
Age predicted heart rate
Tidsram: Day of Exercise Testing
|
achieved percentage of age predicted heart rate
|
Day of Exercise Testing
|
|
physical limits
Tidsram: Day of Exercise Testing
|
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
Tidsram: Day of Exercise Testing
|
increase of the rate pressure product during the test
|
Day of Exercise Testing
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Jürg Hans Beer, Prof., Head of the Department of Internal Medicine
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- ErgoTrial
Plan för individuella deltagardata (IPD)
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Läkemedels- och apparatinformation, studiedokument
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