- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03453671
Strategies to Enhance the Experience of Exercise
10. oktober 2018 oppdatert av: University of Colorado, Boulder
This study aims to test the effect of three cognitive strategies to affect individuals' subjective experience of cardiovascular exercise.
Participants will be randomly assigned to one of three strategies to use while exercising, both during an in-person session and self-directed two week exercise period.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
78
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Colorado
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Boulder, Colorado, Forente stater, 80301
- Center for Innovation and Creativity (CINC)
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 40 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Between the ages of 18 and 40.
- Insufficiently physically active for the past 6-months (i.e., does not meet American College of Sports Medicine [ACSM] guideline for cardiorespiratory exercise). The ACSM guidelines state that all healthy adults should engage in a minimum of 150 minutes per week of moderate intensity cardiorespiratory exercise, or 75 minutes per week of vigorous intensity exercise, or an equivalent combination of the two). On the eligibility screen assessment, we will define moderate and vigorous intensity exercise. Then we will ask individuals to report how many minutes of moderate and vigorous intensity exercise they engage in per week. We will use the ACSM's rule of thumb that 1 minute of moderate intensity exercise is equivalent to 2 minutes of vigorous intensity exercise. This will help to ensure that prospective participants who exercise for less than 150 minutes per week are not actually meeting the ACSM guidelines for cardiorespiratory fitness by engaging in vigorous intensity exercise. Thus, if total minutes of moderate intensity exercise and total minutes of vigorous intensity exercise (multiplied by 2) per week is equal to or greater than 150, callers will not be eligible for study inclusion.
- Physically capable of safely engaging in moderate-intensity physical activity (PA)
- Able and willing to access the Internet daily for two weeks
- Willing to accept random assignment.
- Have a smartphone or other mobile device (e.g., iPod Touch) that can play media (important if participants are assigned to the distraction condition)
- Willing to engage in an exercise intervention specifically involving walking, jogging, running, or hiking (not other types of exercise)
Exclusion Criteria:
- Are diabetic or receiving treatment for a metabolic disorder
- Are currently pregnant
- Are currently on antipsychotic medications
- Have a history of cardiac or respiratory disease
- Are receiving treatment for a heart condition or high blood pressure
- Experience chest pains during and/or not during physical activity
- Have a muscle, bone, or joint problem or injury that limit movement, make exercise painful, or could be made worse by exercising
- Have a close family history of an adverse cardiac event before the age of 50.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Mindfulness
Participants will use the strategy of mindfulness, i.e., present moment awareness with nonjudgment and acceptance, while exercising.
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Participants will use mindfulness techniques while exercising
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Eksperimentell: Distraction
Participants will use the strategy of distraction, i.e., directing their attention to something other than exercise (specifically a podcast) while exercising.
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Participants will distract themselves while exercising
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Aktiv komparator: Self-Monitoring
Participants will monitor their internal experience while exercising, without distraction and without being taught mindfulness skills of nonjudgment and acceptance.
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Participants will use associative attentional focus while exercising
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Affective valence
Tidsramme: 30 minutes
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Affective valence during a 30-minute exercise bout
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30 minutes
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Felt arousal
Tidsramme: 30 minutes
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Felt arousal during a 30-minute exercise bout
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30 minutes
|
Perceived Exertion (RPE)
Tidsramme: 30 minutes
|
Rating of Perceived Exertion during a 30-minute exercise bout
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30 minutes
|
Minutes of exercise
Tidsramme: 2-weeks following initial visit
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Minutes exercised during 2-week at-home intervention
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2-weeks following initial visit
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Affect and perceived exertion: longitudinal
Tidsramme: 2-weeks following initial visit
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Rated affect and perceived exertion during 2-week at-home intervention
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2-weeks following initial visit
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Theory of Planned Behavior: attitudes
Tidsramme: Baseline to 2-week follow-up
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attitudes about exercise behavior
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Baseline to 2-week follow-up
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Theory of Planned Behavior: norms
Tidsramme: Baseline to 2-week follow-up
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subjective norms regarding exercise behavior
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Baseline to 2-week follow-up
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Theory of Planned Behavior: self-efficacy
Tidsramme: Baseline to 2-week follow-up
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self-efficacy for exercise
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Baseline to 2-week follow-up
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Theory of Planned Behavior Constructs
Tidsramme: Baseline to 2-week follow-up
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intentions to engage in future exercise behavior
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Baseline to 2-week follow-up
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Distress tolerance
Tidsramme: Baseline to 2-week follow-up
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Rated ability to tolerate distress
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Baseline to 2-week follow-up
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Defusion skills
Tidsramme: Baseline to 2-week follow-up
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rated ability to "defuse"
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Baseline to 2-week follow-up
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. desember 2017
Primær fullføring (Faktiske)
31. august 2018
Studiet fullført (Faktiske)
31. august 2018
Datoer for studieregistrering
Først innsendt
6. desember 2017
Først innsendt som oppfylte QC-kriteriene
26. februar 2018
Først lagt ut (Faktiske)
5. mars 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. oktober 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. oktober 2018
Sist bekreftet
1. oktober 2018
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 17-0474
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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