- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02507869
A Trial of an Affect-Guided Physical Activity Prescription
23 juli 2015 uppdaterad av: Austin Baldwin, Southern Methodist University
A Pilot Randomized Controlled Trial of an Affect-Guided Physical Activity
Despite awareness of the benefits of engaging in regular physical activity, at least 50% of adults in the US do not meet recommended guidelines for physical activity.
One potential explanation for this lack of regular physical activity is that people often experience exercise as affectively unpleasant.
Evidence suggests that the more positively people experience exercise (i.e., the better they feel while exercising), the more likely they are to engage in regular physical activity.
This may be especially true for people in poor cardiorespiratory condition.
In this randomized trial, investigators compared the effects of an affect-guided exercise prescription (intervention) to a heart rate-guided exercise prescription (control) on change in physical activity minutes among previously underactive adults.
Investigators also tested whether the effect of the intervention was moderated by differences in cardiorespiratory fitness.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Regular physical activity has many benefits for overall health and well-being, and current public health guidelines recommend at least 150 minutes per week of moderate-to-vigorous intensity activity to attain these benefits.
Despite the many benefits of regular activity, the majority of adults in the US fail to meet recommendations for regular physical activity.
One potential explanation for suboptimal levels of physical activity is that exercise is often experienced as affectively unpleasant.
Recent work has demonstrated that the more positive people feel during exercise, the more likely they are to engage in regular physical activity.
Affective response to exercise is modulated by the intensity of the activity: at a vigorous intensity, affective response is almost uniformly negative and unpleasant, whereas at a moderate intensity, there is more inter-individual variability in affective response.
Whether the intensity of the exercise is self-selected or imposed also influences the affective response to exercise, with self-selected intensities being experienced as more pleasant.
Current recommendations for engaging in physical activity focus on the type of training intensities most likely to result in a negative affective response.
The purpose of this pilot trial was to test the effects of an exercise prescription focused on the maintenance of positive affect during exercise.
Investigators randomized participants to one of two exercise prescription conditions: (1) an affect-guided prescription focused on maintaining a positive affective response (intervention), and (2) a heart rate-guided prescription focused on maintaining a moderate intensity (control).
Investigators tested the effects of these two exercise prescriptions on changes in subsequent physical activity after one week and one month among a sample of underactive adults.
Investigators also tested whether the effect of the intervention was moderated by differences in cardiorespiratory fitness.
Studietyp
Interventionell
Inskrivning (Faktisk)
67
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Physically underactive individuals (< 60 minutes of physical activity/week).
Exclusion Criteria:
- Presence of cardiovascular disease, pulmonary disease, or hypertension.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Affect-Guided Prescription
Intervention: Participants in the affect-guided condition are instructed to exercise while monitoring how they feel, and to adjust the intensity of their exercise to maintain a pleasant affective response.
|
Participants adjust the intensity of their exercise to maintain a pleasant affective response.
|
Aktiv komparator: Heart Rate-Guided Prescription
Intervention: Participants in the heart rate-guided condition are instructed to exercise while monitoring their heart rate, and to adjust the intensity of the exercise to maintain a heart rate in the moderate range (64-76% of their HRmax).
|
Participants adjust the intensity of the exercise to maintain a heart rate in the moderate range (64-76% of their HRmax).
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Change in physical activity minutes measured by the 7-day PAR
Tidsram: One week
|
One week
|
Change in physical activity minutes measured by the 7-day PAR
Tidsram: One month
|
One month
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Austin Baldwin, Ph.D., Southern Methodist University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Ekkekakis P, Lind E. Exercise does not feel the same when you are overweight: the impact of self-selected and imposed intensity on affect and exertion. Int J Obes (Lond). 2006 Apr;30(4):652-60. doi: 10.1038/sj.ijo.0803052.
- Ekkekakis P, Parfitt G, Petruzzello SJ. The pleasure and displeasure people feel when they exercise at different intensities: decennial update and progress towards a tripartite rationale for exercise intensity prescription. Sports Med. 2011 Aug 1;41(8):641-71. doi: 10.2165/11590680-000000000-00000.
- Williams DM, Dunsiger S, Miranda R Jr, Gwaltney CJ, Emerson JA, Monti PM, Parisi AF. Recommending self-paced exercise among overweight and obese adults: a randomized pilot study. Ann Behav Med. 2015 Apr;49(2):280-5. doi: 10.1007/s12160-014-9642-7.
- Ekkekakis P, Lind E, Vazou S. Affective responses to increasing levels of exercise intensity in normal-weight, overweight, and obese middle-aged women. Obesity (Silver Spring). 2010 Jan;18(1):79-85. doi: 10.1038/oby.2009.204. Epub 2009 Jun 25.
- Parfitt G, Alrumh A, Rowlands AV. Affect-regulated exercise intensity: does training at an intensity that feels 'good' improve physical health? J Sci Med Sport. 2012 Nov;15(6):548-53. doi: 10.1016/j.jsams.2012.01.005. Epub 2012 May 31.
- Williams DM, Dunsiger S, Jennings EG, Marcus BH. Does affective valence during and immediately following a 10-min walk predict concurrent and future physical activity? Ann Behav Med. 2012 Aug;44(1):43-51. doi: 10.1007/s12160-012-9362-9.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2013
Primärt slutförande (Faktisk)
1 april 2014
Avslutad studie (Faktisk)
1 april 2014
Studieregistreringsdatum
Först inskickad
22 juli 2015
Först inskickad som uppfyllde QC-kriterierna
23 juli 2015
Första postat (Uppskatta)
24 juli 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
24 juli 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 juli 2015
Senast verifierad
1 juli 2015
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2012-098-SMIJ
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Fysisk aktivitet
-
University of ValenciaAktiv, inte rekryterandeAutismspektrumstörning | Attention Deficit Hyper ActivitySpanien
-
Future Biome SARekryteringImmunsvar | Påfrestning | Näring, hälsosam | Tarmmikrobiom | Låggradig kronisk inflammation | Activity of Daily Living | Tarmhälsa | Milda gastrointestinala symtom hos friska vuxna | TarmgenomsläpplighetArgentina
-
NYU Langone HealthAvslutadProcessinstruerad självneuromodulering (PRISM) för Attention Deficit/ Hyperactivity Disorder - VuxnaAttention Deficit Hyper ActivityFörenta staterna
-
Istanbul University - Cerrahpasa (IUC)AvslutadStroke | Dubbel uppgift | Activity of Daily LivingKalkon
-
Robert Bosch Gesellschaft für Medizinische Forschung...Norwegian University of Science and TechnologyAvslutadKognitiv försämring | Fysisk nedsättning | Gångstörning, Sensorimotorisk | Balans | Activity of Daily Living | Mätegenskaper för 5iTUG | BenstyrkaTyskland
-
Texas Woman's UniversityAvslutadIntellektuell funktionsnedsättning | Autismspektrumstörning | Motoriska störningar | Motorfördröjning | Sensoriska störningar | Attention Deficit Hyper Activity
-
Ostfold Hospital TrustThe Dam Foundation; Sykehuset Innlandet HF; Norwegian Health AssociationAvslutadDepression | Livskvalité | Ångest | Kognitivt symtom | Drog användning | Fysisk hälsa | Activity of Daily Living | Neuropsykiatriskt syndromNorge
-
University Hospital, GrenobleAvslutadDiagnos av Arthrogryposis Amyoplasia eller Distal Arthrogryposis | 5-dagars multidisciplinär utvärdering i AMC-kliniken vid National Reference Center | Med Physical Medicine, Medical Genetic and Imaging Departments på Hospital Grenoble AlpesFrankrike
-
Cingulate TherapeuticsRekryteringADHD | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder med hyperaktivitet | ADHD – kombinerad typ | Attention Deficit Hyperactivity Disorder kombinerat | Attention Deficit Hyper Activity | Uppmärksamhetsbrist hyperaktivitetFörenta staterna
-
Cingulate TherapeuticsPremier Research Group plcAktiv, inte rekryterandeADHD | Attention Deficit Hyperactivity Disorder | ADHD – kombinerad typ | Attention Deficit Hyperactivity Disorder kombinerat | Attention Deficit Hyper Activity | Uppmärksamhetsbrist hyperaktivitetFörenta staterna
Kliniska prövningar på Positive affective response
-
Brigham and Women's HospitalAvslutadBeslutsfattande | Form Perception | FärguppfattningFörenta staterna
-
University of IbadanOkänd
-
Northern Care Alliance NHS Foundation TrustAvslutadKronisk obstruktiv lungsjukdom | Emfysem | KOL | Kronisk bronkitStorbritannien
-
Hospital Universitario Virgen de la ArrixacaZoll Medical CorporationAvslutadHjärt-lungräddningSpanien
-
Duke UniversityAnmälan via inbjudan
-
Brigham and Women's HospitalAvslutadÖverensstämmelse med restriktiva RBC-transfusionsriktlinjerFörenta staterna
-
Seoul National University HospitalOkändKolonpolyper | KolonneoplasmerKorea, Republiken av
-
The Netherlands Cancer InstituteUMC UtrechtAvslutadCancergenetik | Psykosociala frågorNederländerna
-
Brigham and Women's HospitalAvslutad