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We Walk Plus Study for Older Adults With Intellectual Disabilities

Aktiv, nicht rekrutierend
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Die klinische Studie NCT04573530 ist eine interventionsstudie zur Untersuchung von Intellektuelle Behinderung und hat den Status aktiv, nicht rekrutierend. Die Studie startete am 15. Juni 2021 und soll 46 Teilnehmer aufnehmen. Durchgeführt von Universität von Illinois in Chicago ist der Abschluss für 15. November 2025 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 15. August 2025 aktualisiert.
Kurzbeschreibung
Determine the feasibility and acceptability of We Walk Plus intervention to promote physical activity and improve cognition for older adults with intellectual disabilities (ID).
Ausführliche Beschreibung
We Walk Plus study consists of: (1) a user friendly physical activity tracker (i.e., Fitbit Charge HR ); (2) user-centered social networking (e.g., Fitbit community); and (3) the iCardia platform for monitoring daily Fitbit physical activity and wear time and sending personalized text-messages targeting physical activity and self-efficacy. The specific aims of this two-arm RCT pilot are to: 1) assess the feasibility and acceptability of the We Walk Plus intervention and 2) explore the preliminary efficacy of We Walk Plus on physical activity and well-being.
Offizieller Titel

We Walk Plus Study: A Walking Program Using Physical Activity Monitors and Social Networking for Older Adults With Intellectual Disabilities

Erkrankungen
Intellektuelle Behinderung
Weitere Studien-IDs
  • 2020-1140
NCT-Nummer
NCT04573530
Studienbeginn (tatsächlich)
2021-06-15
Zuletzt aktualisiert
2025-08-15
Studienende (vorauss.)
2025-11-15
Geplante Rekrutierung
46
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Aktiv, nicht rekrutierend
Stichwörter
physical activity
walking
older adults with an intellectual disability
Primäres Ziel
Andere
Zuteilungsmethode
Randomisiert
Interventionsmodell
Sequentiell
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellWe Walk Plus Intervention
The intervention group will receive a Fitbit, SMS and will be assigned to a private Fitbit community (4-5 participants per group) for 12 weeks. During the intervention, participants will receive weekly personalized SMS on their mobile phones including encouraging messages, reminders, and tips to increase steps, and weekly step goals. The investigators will use a secure, web-based platform, iCardia, to support continuous real-time remote monitoring of activity data from Fitbit devices and personalized communication via SMS based on incoming data. The investigators will set up the Fitbit networking settings on participants' phones to give notifications when there are posts to this group. Individual goals and a weekly team goal of steps will be set up by the research team. Each member will be awarded a badge upon reaching each individual's weekly goal. Teams will also be awarded badges when all team members reach their individual weekly goals.
We Walk Plus Intervention
The frequency and content of weekly personalized SMS are based on each participant's preference. Prior to implementation of intervention, the investigators will conduct focus groups to learn participants' social network activities and preferences, strategies that can be used to encourage engagement via a private Fitbit community network.
Keine InterventionAttention control group
The attention control group will also receive a Fitbit and will be asked to continue with normal daily activities. During the initial in-person session, they will receive the same PA recommendations as the intervention group to walk at least 30 minutes for 5 days or more a week or 10,000 steps a day. However, a plan for improving PA will not be discussed.
Nicht zutreffend
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Physical activity
daily steps
12 weeks
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Cardiovascular fitness
modified six-minute walk test
12 weeks
Self-efficacy to physical activity
Physical Activity Self-efficacy/Social Support scale will be used to assess confidence to perform physical activity
12 weeks
Attention & executive function
Flanker Inhibitory Control and Attention Test -a standard test from the NIH toolbox which has been adapted and validated for individuals with ID to assess one's limited capacities to deal with an abundance of environmental stimulation.
12 weeks
Working memory
List Sorting Working Memory Test-a standard test from the NIH toolbox which has been adapted and validated for individuals with ID to assess the ability to store information.
12 weeks
Executive function
Dimensional Change Card Sort Test -a standard test from the NIH toolbox which has been adapted and validated for individuals with ID to assess one's capacity to plan, organize, and monitor the executive of behaviors.
12 weeks
Processing speed
Pattern Comparison Processing Speed Test- a standard test from the NIH toolbox which has been adapted and validated for individuals with ID to assess the amount of information that can be processed within a certain unit of time.
12 weeks
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene
Mindestalter
35 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
  • Men and women with mild or moderate intellectual disabilities;
  • ages 35-60;
  • able to speak, read English and willing to provide consent to enroll;
  • able to follow instructions and walk, physically inactive;
  • willing to receive SMS, wear Fitbit throughout the study;
  • living with family or in a community residence;
  • support persons are willing to assist participants to ensure the Fitbit functions properly.

  • Inability to follow instructions;
  • diagnosis of coronary disease or uncontrolled hypertension, smokers, physically active;
  • participating in a health promotion program;
  • having mental illness or behavior problems;
  • support persons unable or unwilling to assist participants with Fitbit devices, if needed.
University of Illinois at Chicago logoUniversität von Illinois in Chicago207 aktive klinische Studien zum Erkunden
Verantwortliche Partei
Kueifang Hsieh, Hauptprüfer, Research Associate Professor, University of Illinois at Chicago
Keine Kontaktdaten vorhanden
2 Studienstandorte in 1 Ländern

Illinois

University of Illinois at Chicago, Chicago, Illinois, 60608, United States
Trinity Services Inc., New Lenox, Illinois, 60451, United States