NEAT!2 Sedentary Behavior Reduction for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries
28 juni 2021 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
11
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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South Carolina
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Columbia, South Carolina, Förenta staterna, 29208
- University of South Carolina
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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
40 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
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 |
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Experimentell: 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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Experimentell: 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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Övrig: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Sedentary Behavior at 1 Month
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Timed Up & Go at 1 Month
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline to 3 months
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Physical function assessed by 6 minute walk (total feet)
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Baseline to 3 months
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Maintenance of Changes in Sedentary Behavior at 6 Months
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
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 (Faktisk)
22 juni 2019
Primärt slutförande (Faktisk)
9 september 2020
Avslutad studie (Faktisk)
9 september 2020
Studieregistreringsdatum
Först inskickad
12 juni 2019
Först inskickad som uppfyllde QC-kriterierna
14 juni 2019
Första postat (Faktisk)
17 juni 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 juli 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 juni 2021
Senast verifierad
1 juni 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pro00085868
Plan för individuella deltagardata (IPD)
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