- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Image Group
The patients were looking at a static image of a lavender flower while exercising on the treadmill.
|
|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Patients' performance
Tidsramme: Day of Exercise Testing
|
Patients' performance in metabolic equivalents percentage of age predicted maximum
|
Day of Exercise Testing
|
|
Patients' comfort
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Exercise test duration
Tidsramme: Day of Exercise Testing
|
Exercise test duration in min:sec
|
Day of Exercise Testing
|
|
Age predicted heart rate
Tidsramme: Day of Exercise Testing
|
achieved percentage of age predicted heart rate
|
Day of Exercise Testing
|
|
physical limits
Tidsramme: 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
Tidsramme: Day of Exercise Testing
|
increase of the rate pressure product during the test
|
Day of Exercise Testing
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Jürg Hans Beer, Prof., Head of the Department of Internal Medicine
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- ErgoTrial
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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