- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03453671
Strategies to Enhance the Experience of Exercise
10. oktober 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
78
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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Colorado
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Boulder, Colorado, Forenede Stater, 80301
- Center for Innovation and Creativity (CINC)
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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 til 40 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
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: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
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Perceived Exertion (RPE)
Tidsramme: 30 minutes
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Rating of Perceived Exertion during a 30-minute exercise bout
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30 minutes
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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 |
Foranstaltningsbeskrivelse |
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
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
15. december 2017
Primær færdiggørelse (Faktiske)
31. august 2018
Studieafslutning (Faktiske)
31. august 2018
Datoer for studieregistrering
Først indsendt
6. december 2017
Først indsendt, der opfyldte QC-kriterier
26. februar 2018
Først opslået (Faktiske)
5. marts 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. oktober 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. oktober 2018
Sidst verificeret
1. oktober 2018
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 17-0474
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Uafklaret
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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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