- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03987932
NEAT!2 Sedentary Behavior Reduction for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries
28. juni 2021 oppdatert av: Christine A Pellegrini, PhD, University of South Carolina
NEAT!2 Sedentary Behavior Reduction Intervention for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries
This study will evaluate the effectiveness of an mHealth sedentary reduction program over a 6-month period of time in adults with past or present knee symptoms, injuries, or surgeries.
Studieoversikt
Status
Avsluttet
Intervensjon / Behandling
Detaljert beskrivelse
Sedentary behavior, in excess, is associated with numerous health consequences including poor physical function.
Older adults with symptomatic knee pain spend the majority of their waking hours engaging in sedentary behaviors.
To reduce the risk of disability, improve quality of life, and prevent deterioration in physical function, it is imperative the investigators develop ways to reduce sedentary time.
Smartphone ownership among older adults is increasing and may provide a scalable opportunity to disseminate a sedentary reduction intervention.
Therefore, this study aims to evaluate and compare changes in sedentary behavior and physical function between an mHealth sedentary reduction, mHealth intervention plus coaching, and delayed mHealth group.
Sedentary behavior and physical function will be assessed at baseline, 1 month, 3 months, and 6 months after randomization.
Studietype
Intervensjonell
Registrering (Faktiske)
11
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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South Carolina
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Columbia, South Carolina, Forente stater, 29208
- University of South Carolina
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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
40 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Be at least 40 years of age
- Own an Android or Apple smartphone
- Have their smartphone near them (in their pocket, in their hand, or within 10 feet of them) for >50% of their waking day
- Be willing to download the study application and be compatible on their smartphone
- Spend at least 7 hours/day sitting
- Have at least 4 days of valid accelerometer data at baseline
- Have knee pain (at least one knee with pain, aching, or stiffness on most days for one month of the last 12 months), knee injury, or knee replacement within the last 5 years
- Read, speak, and understand English
Exclusion Criteria:
- Have any contraindications to activity
- Have a mobility limiting comorbidity
- Have a scheduled surgery within the next 6 months
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: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: NEAT!2
Participants will be asked to use the NEAT!2 app for 3 months after randomization.
App use between 4-6 months is optional.
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Participants randomized to NEAT!2 will have their NEAT!2 app turned on after randomization.
When 30 minutes of continuous non-movement or sedentary time is detected, the NEAT!2 app will provide a vibration or audio notification as well as display a reminder on the phone's lock/home screen.
Participants will be asked to use the app for the 3 months of the intervention.
Participants will be given an initial goal to reduce total sedentary time by 30 minutes/day, ultimately progressing to a 90 minute/day reduction by 3 months.
After the 3-month assessment, participants randomized to NEAT!2 will have the option to continue using the app until 6 months.
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Eksperimentell: NEAT!2+Calls
Participants will be asked to use the NEAT!2 app for 3 months after randomization.
In addition, participants will receive bi-weekly coaching calls over 3 months.
App use between 4-6 months is optional.
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Participants in this group will have their NEAT!2 app turned on after randomization.
In addition, to receiving the identical app and given the same goals as participants randomized to NEAT!2, NEAT!2+Calls participants will receive 10-15 minute bi-weekly coaching calls.
After the 3-month assessment, participants will have the option to continue using the app until 6 months.
During this time, participants will not receive any coaching calls.
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Annen: Delayed NEAT!2
Participants will receive the NEAT!2 app to use between 3 and 6 months.
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Participants randomized to Delayed NEAT!2 will not receive any contact or app between baseline and 3 months.
However, after completing the 3-month assessment, participants will receive the NEAT!2 application.
Participants will then have the option to use the app between 3 and 6 months.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in Sedentary Behavior at 1 Month
Tidsramme: Baseline to 1 month
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Daily sedentary behavior objectively measured by activpal
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Baseline to 1 month
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Change in Sedentary Behavior at 3 Months
Tidsramme: Baseline to 3 months
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Daily sedentary behavior objectively measured by activpal
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Baseline to 3 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in Timed Up & Go at 1 Month
Tidsramme: Baseline to 1 month
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Physical function assessed by Timed Up & Go (seconds)
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Baseline to 1 month
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Change in Chair Stands at 1 Month
Tidsramme: Baseline to 1 month
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Physical function assessed by Chair Stand Test (# stands in 30 seconds)
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Baseline to 1 month
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Change in 6 Minute Walk at 1 Month
Tidsramme: Baseline to 1 month
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Physical function assessed by 6 minute walk (total feet)
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Baseline to 1 month
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Change in Timed Up & Go at 3 Months
Tidsramme: Baseline to 3 months
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Physical function assessed by Timed Up & Go (seconds)
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Baseline to 3 months
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Change in Chair Stands at 3 Months
Tidsramme: Baseline to 3 months
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Physical function assessed by Chair Stand Test (# stands in 30 seconds)
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Baseline to 3 months
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Change in 6 Minute Walk at 3 Months
Tidsramme: Baseline to 3 months
|
Physical function assessed by 6 minute walk (total feet)
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Baseline to 3 months
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Maintenance of Changes in Sedentary Behavior at 6 Months
Tidsramme: Baseline to 6 months
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Daily sedentary behavior objectively measured by activpal
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Baseline to 6 months
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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)
22. juni 2019
Primær fullføring (Faktiske)
9. september 2020
Studiet fullført (Faktiske)
9. september 2020
Datoer for studieregistrering
Først innsendt
12. juni 2019
Først innsendt som oppfylte QC-kriteriene
14. juni 2019
Først lagt ut (Faktiske)
17. juni 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. juli 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. juni 2021
Sist bekreftet
1. juni 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pro00085868
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