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Mobilizing Hispanics With Knee Osteoarthritis
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O estudo clínico NCT06522906 é um ensaio intervencionista para Osteoartrite do joelho. Seu status atual é: recrutando. O estudo começou em 15 de novembro de 2024 e pretende incluir 44 participantes. Coordenado por University of Arizona e deve ser concluído em 31 de dezembro de 2025. Essas informações foram atualizadas no ClinicalTrials.gov em 3 de outubro de 2025.
Resumo
The objective is to conduct an early-stage clinical trial in order to provide data required to support a future clinical trial to demonstrate the effectiveness of a culturally acceptable treatment program to increase exercise and regular physical activity among Hispanics with knee osteoarthritis (OA).
Hispanic patients with knee OA paired with a chosen family member/close friend will be recruited for study participation. A pilot randomized controlled trial will be conducted. Study pairs will be randomized to receive either: 1) an intervention that will be administered by live video consultations and will include educational sessions about OA, a muscle strengthening program, and a program that will aim to promote regular physical activity involving study pairs; or 2) a control treatment that only includes live video educational sessions about OA.
Study participants will fill out a survey before the start of the study and 3 months after.
Descrição detalhada
Feasibility of the intervention will be based on the number of study pairs that will be recruited during the study and on attendance to the intervention sessions, and acceptability will be based on quantitative acceptability (e.g., program satisfaction) and qualitative measures.
Título oficial
Mobilizing Hispanics With Knee Osteoarthritis Using a Dyad-based Approach: Pilot Randomized Controlled Trial
Condições
Osteoartrite do joelhoOutros IDs do estudo
- 00004081
- 991639 (Outro financiamento) (Rheumatology Research Foundation)
Número NCT
Data de início (real)
2024-11-15
Última atualização postada
2025-10-03
Data de conclusão (estimada)
2025-12-31
Inscrição (estimada)
44
Tipo de estudo
Intervencionista
FASE
N/A
Status
Recrutando
Palavras-chave
Hispanic
Exercise
Exercise
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Atribuição paralela
Cegamento (Mascaramento)
Duplo-cego (Mascaramento duplo)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalIntervention Treatments include educational sessions about OA, a muscle strengthening program, and a program that will aim to promote regular physical activity involving dyads | Muscle Strengthening Patients will be offered five video consultations (30-45 minutes each) with a physical therapist over 3 months. The physical therapist will prescribe an exercise program individualized to the OA patient that will include strengthening exercises (2 quadriceps, 1 hip/gluteal, 1 hamstrings/gluteal, 1 calf, and 1 other) to be performed at home 3x/week. General Physical Activity The general program will consist of four 60-minute live video consultations conducted by a promotora. The first three sessions will be conducted every 2 weeks, with a booster session occurring one month later. The promotora will help dyads set achievable personalized physical activity goals. Educação Administered by a promotora, treatment will include 4 live video educational sessions about OA |
Comparador ativoControl Treatment only includes live video educational sessions about OA | Educação Administered by a promotora, treatment will include 4 live video educational sessions about OA |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Educational sessions attended | Number of educational sessions attended by patients and partners will be recorded | 3 month follow-up |
Adherence with muscle strengthening program | Intervention group only. Patients will rate how much they agree/disagree (11-point numerical rating scale) with the statement: "I have been doing my exercises exactly as I was asked by my physical therapist (# sessions, exercises and repetitions)". | 3 month follow-up |
Adherence with physical activity plan | Intervention group only. Study dyads will rate how much they agree/disagree in an 11-point numerical rating scale with the statement: "I followed the physical activity plan that my promotora helped me develop". | 3 month follow-up |
Satisfaction with program | Satisfaction with the program/s, using a 7-point numerical rating scale (1="extremely unsatisfied", 7="extremely satisfied") | 3 month follow-up |
Perceived helpfulness | Perceived helpfulness of the program/s in improving OA symptoms, increasing physical activity and improving communication with their chosen partner, and the likelihood of recommending the program to OA patients and their partners, using a 5-point numerical rating scale (1=not at all/definitely would not, 5=extremely/definitely would not) | 3 month follow-up |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Osteoarthritis disease severity | Severity of OA symptoms will be measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Change in two subscale scores (joint pain \[primary outcome, range 0-20\] and physical function \[0-68\]) will be calculated. | Baseline and 3 month follow-up |
Physical activity | Physical activity will be measured using a pedometer. Participants will be asked to wear a pedometer at the waist for 7 consecutive days to record the number of steps taken per day. | Baseline and 3 month follow-up |
Physical activity (self-report) | Physical activity (self-report) of study dyads in the last week will also be measured using the Physical Activity Scale for the Elderly (range: 0-400, higher scores indicate greater physical activity | Baseline and 3 month follow-up |
Critérios de elegibilidade
Idades elegíveis
Adulto, Adulto mais velho
Idade mínima
18 Years
Sexos elegíveis
Todos
Aceita voluntários saudáveis
Sim
- Hispanic/Latino ethnicity
- ≥ 50 years of age
- Access to a device with internet connection
- Chronic, frequent knee pain (National Health and Nutrition Examination Survey criteria)
- Meet American College of Rheumatology criteria for knee OA WOMAC pain score of ≥4 and at least moderate pain (score 2) for at least 2 questions
- Unknown or non-Hispanic ethnicity
- Condition that prevents ability to provide consent
- Illness with a life expectancy <12 months
- History of arthroplasty or prosthetic leg
- Inflammatory arthritis (e.g., rheumatoid arthritis, systemic lupus erythematosus, gout)
- Condition that prevents exercise or physical activity (e.g., unstable cardiovascular disease)
University of Arizona- Universidade Temple73 estudos clínicos ativos para explorar
- University of Melbourne
Contato central do estudo
Contato: Jazmin Dagnino, (520) 621-6823, [email protected]
Contato: Ernest Vina, MD, (520) 626-1613, [email protected]
1 Locais do estudo em 1 países
Arizona
Banner University Medical Center, Tucson, Arizona, 85713, United States
Jazmin Dagnino, Contato, (520) 626-5026, [email protected]
Ernest Vina, MD, Investigador principal
Recrutando