bèta
Trial Radar AI
De klinische studie NCT06462560 (LIFT-OA) voor Knieosteoartritis is recruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
Eén studie komt overeen met de filtercriteria
Kaartweergave
Terug naar zoekresultaten

Live and Interactive Fitness Training Program (Vivo Knee OA) (LIFT-OA)

Recruterend
Informatie over klinische studies is voornamelijk in het Engels beschikbaar. Trial Radar AI kan echter helpen! Klik op 'Leg studie uit' om de informatie over de studie te bekijken en te bespreken in de taal van uw keuze.
De klinische studie NCT06462560 (LIFT-OA) is een interventioneel studie bij Knieosteoartritis met de status recruterend. Het doel is om 334 deelnemers te includeren vanaf 28 april 2024. De studie wordt geleid door Intermountain Health en de voltooiing is gepland op 1 april 2026. Laatste update op ClinicalTrials.gov: 17 juni 2024.
Beknopte samenvatting
Potential participants will be screened at clinic. Patients who meet eligibility criteria will be considered for study. After written informed consent is obtained, participants will complete baseline testing and participants who meet eligibility criteria will be randomized 1:1 to 2 treatment arms: Vivo Arm: Vivo twice a week for 6 months and Usual Care Arm: meet with ATC and given Medbridge home exercise program for 6 months. All participants will be followed for 12 months, and will be assessed at 3-,6-, and 12-months. All participants will complete functional assessments, OA patient reported outcomes measures, quality of life, exercise self-efficacy, and fall risk questionnaires, and health care utilization report at each testing visit. A subset of Vivo participants will be asked satisfaction questions at the 3 and 6 month time points.
Officiële titel

Improving Physical Function and Quality of Life in Adults With Knee Osteoarthritis Utilizing an Online Live and Interactive Fitness Training Program (Vivo Knee OA)

Aandoeningen
Knieosteoartritis
Andere studie-ID's
  • LIFT-OA
  • 1052693
NCT-ID
NCT06462560
Startdatum (Werkelijk)
2024-04-28
Laatste update geplaatst
2024-06-17
Verwachte einddatum
2026-04
Inschrijving (Geschat)
334
Studietype
Interventioneel
FASE
N.v.t.
Status
Recruterend
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelVivo Online Exercise program
Vivo Online Exercise Program
Virtual online exercise programs conducted by the Vivo team consisting of multiple time a week group live programs
Actieve comparatorMedbridge Home Exercise Program
Medbridge Home Program
At home exercise program accessed through exercise descriptions and short vidoes
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Primary Endpoint 1
Changes from baseline in number of chair stands done in 30-seconds at 3 and 6 months.
6 months post intervention
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Secondary Endpoint 1
Changes from baseline in WOMAC score at 3 and 6 months.
6 months post intervention
Secondary Endpoint 2
Changes from baseline in length of time (seconds) to do 1-leg balance stance at 3 and 6 months.
6 months post intervention
Secondary Endpoint 3
Changes from baseline in seconds to complete the 8-foot up and go at 3 and 6 months.
6 months post intervention
Secondary Endpoint 4
Changes from baseline in number of knee raises completed in 2-minute knee raise at 3 and 6 months
6 months post intervention
Secondary Endpoint 5
Changes from baseline in number of arm-curls done in 30 seconds at 3 and 6 months
6 months post intervention
Secondary Endpoint 6
Changes from baseline in PROMIS-Plus-Osteoarthritis of the Knee (OAK) score at 3 and 6 months
6 months post intervention
Secondary Endpoint 7
Changes from baseline in exercise self-efficacy scale score at 3 and 6 months
6 months post intervention
Secondary Endpoint 8
Changes from baseline in quality of life (SF-36 score) at 3 and 6 months
6 months post intervention
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
55 Years
Geslachten die in aanmerking komen voor de studie
Allen

  • 55-85 years of age

  • Diagnosis of Osteoarthritis within the prior 6 months

  • Symptomatic OA defined as self-report:

    • Pain in the knee(s) on most days of the month

    • Difficulty with at least one of the following because of knee pain:

      • walking ¼ of a mile
      • climbing stairs
      • getting in and out of a car, bath, or bed
      • rising from a chair
      • or performing shopping, cleaning, or self-care activities

  • Radiographic KL grade II-III (using Kellgren and Lawrence criteria) of one or both knees

  • Physically able to participate in strength training - able to do one chair stand unassisted in order to test change in 30-second chair stand

  • Ambulatory and community-dwelling

  • Sedentary or insufficiently active as measured by the PAVS

  • Access to Wi-Fi in defined exercise space

  • BMI of 20-34.9 kg/m2

  • Document medication specific to OA and knee pain

  • Willing and able to provide consent

  • Neurological conditions causing functional impairments (Parkinson's disease, MS, ALS)
  • Diagnosis of dementia
  • Inability to complete ≥1 ADLs without assistance.
  • Knee surgery in the past 6 months
  • Severe osteoporosis T-score < -3.5
  • No concurrent enrollment in physical therapy for knee pain
  • No concurrent enrollment in the Intermountain Arthrofit program
  • Under the age of 55 or ≥85
  • Asymptomatic OA
  • Not having knee pain or having significant knee pain (WOMAC Pain score of ≤3 or ≥18)
  • KL Grade 1 or 4
  • BMI above 34.9 kg/m2 or ≤20 kg/m2
  • Participation in formal strength training more than 30 minutes a week in the past 6 months.
  • PAVS - Participating in 150 minutes per week of moderate intensity physical activity or 75 minutes of vigorous intensity activity, or an equivalent combination of moderate and vigorous intensity physical activity.
  • Co-morbid disease that would threaten safety or impair ability to participate in a live and interactive strength training program
  • Symptomatic or severe coronary artery disease; peripheral vascular disease
  • Untreated hypertension
  • Active cancer other than skin cancer
Intermountain Health Care, Inc. logoIntermountain Health28 actieve klinische studies om te verkennen
Impactiv, Inc. logoImpactiv, Inc.
Centraal Contactpersoon
Contact: Amelia Millward, 801-507-8095, [email protected]
1 Studielocaties in 1 landen

Utah

Intermountain Health, Murray, Utah, 84107, United States
Amelia Millward, Contact, 801-507-8095, [email protected]
Anthony Beutler, MD, Hoofdonderzoeker
Recruterend