- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03513380
Can Gaming Get You Fit? A High-Intensity Exergaming Intervention in Adults
9. december 2019 opdateret af: Norwegian University of Science and Technology
Motivational High Intensity Training Through a Cutting-edge Gaming Platform. A Randomised, Controlled Trial
The purpose of this project is to assess if playing a newly developed videogame that require physical activity (e.g.
exergame) can lead to health benefits.
The project will include 50 adult participants that are not particularly physically active.
They will be randomized into two groups where one group will be given free access to the exergame for 6 months.
The physical fitness (maximal oxygen consumption), blood markers of cardiometabolic health and body composition of the subjects will be tested before, mid-ways and after the intervention period.
Also, the participants gaming frequency will be registered throughout the 6-month period.
Aim of this study is to investigate if access to this game can provide health benefits for individuals who are not motivated to take part in regular physical activity.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
52
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Trondheim, Norge, 7491
- Department of Circulation and Medical Imaging
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Sedentary (<150 mins of moderate intensity physical activity/week)
- Able to ride a bike for up to 60 minutes
Exclusion Criteria:
- Known cardiovascular disease
- Taking beta-blockers or anti-arrhythmic drugs
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Exergaming
free access to the exergame PedalTanks
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free access to the exergame PedalTanks during 6 months
Andre navne:
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Ingen indgriben: Control
recommended to continue with their normal daily routine
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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VO2max (Maximal Aerobic Capacity)
Tidsramme: 3 months
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3 months
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VO2max (Maximal Aerobic Capacity)
Tidsramme: 6 months
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6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Daily average energy expenditure
Tidsramme: 3 and 6 months
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Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 3-months and 6-months.
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3 and 6 months
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Daily average number of steps
Tidsramme: 3 and 6 months
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Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 3-months and 6-months.
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3 and 6 months
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Daily time in sedentary activity (< 3.0 metabolic equivalents = METs)
Tidsramme: 3 and 6 months
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Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 3-months and 6-months.
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3 and 6 months
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Daily time in moderate intensity activity (3.0-6.0 metabolic equivalents = METs)
Tidsramme: 3 and 6 months
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Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 3-months and 6-months.
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3 and 6 months
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Daily time in vigorous intensity activity (6.0-9.0 metabolic equivalents = METs)
Tidsramme: 3 and 6 months
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Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 3-months and 6-months.
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3 and 6 months
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Daily time in very vigorous intensity activity (>9.0 metabolic equivalents = METs)
Tidsramme: 3 and 6 months
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Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 3-months and 6-months.
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3 and 6 months
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Daily average total physical activity duration
Tidsramme: 3 and 6 months
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Measured by activity monitors (SenseWear Armband) which participants will wear for one week at start of intervention period, 3-months and 6-months.
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3 and 6 months
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Bioelectrical impedance
Tidsramme: 3 and 6 months
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Body composition assessed using bioelectrical impedance analysis (InBody 720)
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3 and 6 months
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Blood Pressure
Tidsramme: 3 and 6 months
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3 and 6 months
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Fasting circulating glucose, as blood marker of cardiometabolic health
Tidsramme: 6 months
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6 months
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Lipid profile, as blood marker of cardiometabolic health
Tidsramme: 6 months
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6 months
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Circulating insulin concentration, as blood marker of cardiometabolic health
Tidsramme: 6 months
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6 months
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glucose response to a 2 hour glucose tolerance test, as blood marker of cardiometabolic health
Tidsramme: 6 months
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6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
25. maj 2018
Primær færdiggørelse (Faktiske)
30. november 2019
Studieafslutning (Faktiske)
30. november 2019
Datoer for studieregistrering
Først indsendt
5. april 2018
Først indsendt, der opfyldte QC-kriterier
30. april 2018
Først opslået (Faktiske)
1. maj 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. december 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. december 2019
Sidst verificeret
1. december 2019
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2017/1501
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
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