- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07452107
Effekterne af en digital mikro-bevægelsesintervention på velvære og akademiske resultater blandt universitetsstuderende
Effekter af en digital mikro-bevægelses-intervention på trivsel og akademiske resultater hos universitetsstuderende: Et randomiseret kontrolleret forsøg
Formålet med denne randomiserede kontrollerede undersøgelse er at undersøge, om et 21-dages fysisk modstandsdygtighedsprogram (baseret på bevægelse) kan forbedre mentalt velvære, følelsesmæssig regulering og akademisk funktion hos universitetsstuderende.
De vigtigste spørgsmål, det sigter mod at besvare, er:
Forbedrer deltagelse i et 21-dages fysisk modstandsdygtighedsprogram studerendes velvære (f.eks. depression, angst, stress, affekt, livstilfredshed og opfattet sundhed)?
Forbedrer programmet studerendes akademiske og selvregulerende resultater (f.eks. engagement, udbrændthed, udsættelse, produktivitet, følelsesregulering, coping og selvkontrollkapacitet)?
Forskere vil sammenligne studerende, der gennemfører det fysiske modstandsdygtighedsprogram med det samme, med studerende i en ventelistekontrolgruppe for at se, om deltagelse i programmet fører til større forbedringer i velvære og akademisk relaterede resultater.
Deltagerne vil:
Tilmelde sig online og give informeret samtykke
Blive tilfældigt tildelt enten interventionsgruppen eller en ventelistekontrolgruppe
Modtage daglige mikrobevægelsesopgaver og påmindelser via Telegram i 21 dage (interventionsgruppe)
Udføre online spørgeskemaundersøgelser ved baseline, efter intervention og en 2-ugers opfølgning
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Singapore, Singapore
- Singapore Management University, Online
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Studerende ved Singapore Management University
- Bruger Telegram
Eksklusionskriterier:
- Under 18 år gammel
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Interventionsgruppe
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Interventionen er et 21-dages digitalt leveret fysisk robusthedsprogram, der består af daglige, korte, bevægelsesbaserede aktiviteter designet til at støtte mental trivsel og akademisk funktion hos universitetsstuderende. Programmet omfatter lavintensiv fysisk bevægelse, åndedrætsøvelser og kropsbaserede reguleringspraksisser, der kan gennemføres selvstændigt uden specialudstyr eller tidligere fysisk træning. Deltagere tildelt interventionsgruppen modtager én struktureret bevægelsesopgave pr. dag i 21 på hinanden følgende dage. Opgaverne leveres via en Telegram-kanal, ledsaget af korte digitale påmindelser for at fremme engagement. Hver opgave er designet til at være kort i varighed, fleksibel i timing og gennemførlig inden for daglige rutiner, med vægt på konsistens frem for fysisk anstrengelse eller præstation. Interventionen er selvstyret og asynkron, uden personlig kontakt, livesessioner eller direkte tilsyn.
Andre navne:
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Ingen indgriben: Ventelistekontrol
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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State anxiety
Tidsramme: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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State anxiety will be assessed using the 6-item Spielberger State-Trait Anxiety Inventory STAI-6 Six items (e.g., "I was worried these past 2 weeks.")
rated from 1 (Not at all) to 4 (Very much so) will be averaged for a composite score.
Higher scores indicate greater levels of anxiety.
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Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Procrastination
Tidsramme: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Procrastination will be assessed using six items from the Irrational Procrastination Scale, such as "At the end of these past 2 weeks, I know I could have spent the time this week better."
Participants will respond on a 1-5 scale (1 = Very seldom or not true of me, 5 = Very often true, or true with me), and higher average scores indicate higher levels of procrastination.
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Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Implementeringsintention
Tidsramme: Tilmelding til afslutningen af interventionen efter 3 uger og afslutningen af opfølgningen efter 5 uger
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Implementeringsintention vil blive målt ved hjælp af det enkeltstående spørgsmål "I løbet af de seneste 14 dage har jeg taget skridt for at nå mine mål for måneden."
bedømt fra 1 (Meget uenig) til 5 (Meget enig), hvor en højere score indikerer højere implementeringsintention.
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Tilmelding til afslutningen af interventionen efter 3 uger og afslutningen af opfølgningen efter 5 uger
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Målstatus
Tidsramme: Indmeldelse til afslutningen af interventionen efter 3 uger og afslutningen af opfølgningen efter 5 uger
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Målfremdrift vil blive målt ved hjælp af det enkelte spørgsmål "I løbet af de sidste 14 dage har jeg set fremskridt i retning af mine mål for måneden."
scoret fra 1 (Meget uenig) til 5 (Meget enig), hvor en højere score indikerer større målfremdrift.
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Indmeldelse til afslutningen af interventionen efter 3 uger og afslutningen af opfølgningen efter 5 uger
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Opfattet helbred
Tidsramme: Tilmelding til afslutningen af interventionen efter 3 uger og afslutningen af opfølgningen efter 5 uger
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Opfattet helbred vil blive vurderet ved hjælp af et enkeltspørgsmål selvrapporteringsmål for generel helbredsstatus.
Deltagerne vil besvare spørgsmålet: "Hvordan vil du vurdere dit fysiske helbred i løbet af de sidste to uger?"
Svar vil blive vurderet på en 5-punkts skala fra 1 (Dårlig) til 5 (Fremragende).
Højere score indikerer bedre opfattet fysisk helbred.
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Tilmelding til afslutningen af interventionen efter 3 uger og afslutningen af opfølgningen efter 5 uger
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Productivity
Tidsramme: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Productivity will be assessed using the Task Performance subscale of the Individual Work Performance Questionnaire (IWPQ), adapted to the academic context.
Participants will respond to five items (e.g., "I was able to plan my work so that I finished it on time") with reference to their schoolwork.
Items will be rated on a 6-point scale from 0 (seldom) to 5 (always) and then the scores will be averaged, with higher scores indicating greater productivity.
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Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Study Burnout
Tidsramme: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Study burnout will be measured using the 9-item Study Burnout Inventory.
Participants will indicate how well each item described their experiences (e.g., "I felt a lack of motivation in studying and often think of giving up") on a 6-point scale from 1 (Completely disagree) to 6 (Completely agree).
Scores will be averaged, with higher scores indicating greater academic burnout.
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Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Study Engagement
Tidsramme: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Study engagement will be measured using the 9-item Study Engagement Inventory.
Participants will rate items such as "I found studying full of meaning and purpose" based on their experiences.
Responses will be given on a 6-point Likert scale ranging from 1 (Completely disagree) to 6 (Completely agree) and higher scores will indicate greater levels of academic engagement.
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Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Depression
Tidsramme: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Depression will be measured using an adapted version of the 10-item Short Depression Scale Revised (CES-D-R 10).
The scale includes the sample item "I felt that everything I did was an effort."
and is scored from 1 (Rarely or none of the time) to 4 (All of the time).
Scores will be averaged and higher scores indicate higher risk of depression.
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Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Life Satisfaction
Tidsramme: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Life satisfaction will be measured using an adapted version of Diener's Satisfaction With Life Scale (SWLS).
The scale includes 5 items e.g.
"In most ways, these past 2 weeks have been close to ideal" and is scored from 1 (Strongly disagree) to 7 (Strongly agree).
Scores will be summed and higher scores indicate higher life satisfaction.
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Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Perceived Stress
Tidsramme: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Perceived stress will be measured by an adapted version of the 4-item Perceived Stress Scale (PSS) developed by Cohen and colleagues.
One sample item includes "In the last 2 weeks, how often have you felt difficulties piling up so high that you could not overcome them?" and items are scored from 0 (Never) to 4 (Very often).
The composite score is calculated by summing the scores of all items; higher scores indicate higher levels of perceived stress.
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Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Positive and Negative Affect
Tidsramme: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Positive Affect (PA) and Negative Affect (NA) will be evaluated using the Circumplex Model of Affect.
Participants will rate feelings such as 'Energetic' and 'Dejected' experienced over the past two weeks, from a scale of 1 to 5 (1 = Not at all, 5 = Extremely).
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Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Coping
Tidsramme: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Coping strategies will be assessed using the Brief COPE which is a 28-item self-report measure assessing a range of adaptive and maladaptive coping responses to stress.
Participants will indicate how frequently they have engaged in various coping behaviours in response to stress over the past two weeks (e.g., "I've been taking action to try to make the situation better").
Items will be rated on a 4-point scale from 1 (I haven't been doing this at all) to 4 (I've been doing this a lot).
Scores will then be averaged for each coping strategy, with higher scores indicating greater use of that coping strategy.
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Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Emotion Regulation
Tidsramme: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Emotion regulation will be assessed using the Emotion Regulation Questionnaire (ERQ), which is a 10-item self-report measure assessing two emotion regulation strategies: cognitive reappraisal and expressive suppression.
Participants will indicate the extent to which they agree with statements describing how they typically regulate their emotions (e.g., "I control my emotions by changing the way I think about the situation I'm in").
Items are rated on a 7-point scale from 1 (strongly disagree) to 7 (strongly agree).
Subscale scores will be computed by averaging items corresponding to cognitive reappraisal and expressive suppression, with higher scores indicating greater use of the respective emotion regulation strategy.
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Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Self-Control Capacity
Tidsramme: Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Self-control capacity will be assessed using the Brief State Self-Control Capacity Scale (BSSCS), which is a 5-item self-report measure assessing individuals' perceived momentary self-control resources.
Participants will indicate the extent to which each statement reflects their experiences over the past two weeks (e.g., "I felt like my willpower was gone").
Items are rated on a 7-point scale from 1 (not true) to 7 (very true).
Items will be averaged to compute a composite score, with higher scores indicating greater state self-control capacity.
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Enrollment to the end of intervention at 3 weeks and the end of follow-up at 5 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
- Andresen EM, Malmgren JA, Carter WB, Patrick DL. Screening for depression in well older adults: evaluation of a short form of the CES-D (Center for Epidemiologic Studies Depression Scale). Am J Prev Med. 1994 Mar-Apr;10(2):77-84.
- Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.
- Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. doi: 10.1037/0022-3514.85.2.348.
- Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x.
- Steel, P. D. G. (2002). The measurement and nature of procrastination. University of Minnesota.
- Salmela-Aro, K., & Read, S. (2017). Study engagement and burnout profiles among Finnish higher education students. Burnout Research, 7, 21-28. https://doi.org/10.1016/j.burn.2017.11.001
- Koopmans, L., Bernaards, C., Hildebrandt, V., van Buuren, S., van der Beek, A. J., & de Vet, H. C. W. (2013). Development of an individual work performance questionnaire. International Journal of Productivity and Performance Management, 62(1), 6-28. https://doi.org/10.1108/17410401311285273
- Lindner, C., Lindner, M. A., & Retelsdorf, J. (2019). Measuring self-control depletion in achievement situations: A validation of the 5-item brief state self-control capacity scale. Diagnostica, 65(4), 228-242. https://doi.org/10.1026/0012-1924/a000230
- Conner, T. S., & Silvia, P. J. (2015). Creative Days: A Daily Diary Study of Emotion, Personality, and Everyday Creativity. Psychology of Aesthetics, Creativity, and the Arts, 9(4), 463-470. https://doi.org/10.1037/aca0000022
- Russell, J. A. (1980). A circumplex model of affect. Journal of Personality and Social Psychology, 39(6), 1161-1178. https://doi.org/10.1037/h0077714
- Koopmans L, Bernaards CM, Hildebrandt VH, de Vet HC, van der Beek AJ. Construct validity of the individual work performance questionnaire. J Occup Environ Med. 2014 Mar;56(3):331-7. doi: 10.1097/JOM.0000000000000113.
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
- IRB-26-037-A031(226)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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