- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03987932
NEAT!2 Sedentary Behavior Reduction for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries
28. juni 2021 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
11
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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South Carolina
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Columbia, South Carolina, Forenede Stater, 29208
- University of South Carolina
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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
40 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
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
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Eksperimentel: 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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Andet: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Physical function assessed by Chair Stand Test (# stands in 30 seconds)
|
Baseline to 3 months
|
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 |
Foranstaltningsbeskrivelse |
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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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)
22. juni 2019
Primær færdiggørelse (Faktiske)
9. september 2020
Studieafslutning (Faktiske)
9. september 2020
Datoer for studieregistrering
Først indsendt
12. juni 2019
Først indsendt, der opfyldte QC-kriterier
14. juni 2019
Først opslået (Faktiske)
17. juni 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. juli 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. juni 2021
Sidst verificeret
1. juni 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pro00085868
Plan for individuelle deltagerdata (IPD)
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