Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients (CLIP-OA)
10 de octubre de 2022 actualizado por: Brian Focht, Ohio State University
The Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients: CLIP-OA
The Collaborative Lifestyle Intervention Program in Knee OsteoArthritis Patients (CLIP-OA) compares a novel community-based exercise and dietary weight loss program to the Arthritis Foundation's Walk with Ease intervention on improved mobility in knee osteoarthritis (OA) patients.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Knee OA is a chronic, progressive, degenerative disease that affects over 20 million Americans, and is cited as the primary cause for activity restriction and physical disability in older adults. The joint damage and symptoms (i.e., pain, stiffness, and fatigue) accompanying symptomatic knee OA result in activity restriction, muscle atrophy, reduced quality of life and difficulty in performance of functional tasks.
Despite the well-established benefits of the Arthritis Foundation's (AF) exercise programs, recent evidence suggests that lifestyle interventions combining Exercise and Dietary Weight Loss (EX+DWL) results in superior improvements in key clinical outcomes in older, overweight or obese knee OA patients.
Primary Aim: To compare the effects of a novel community-based EX+DWL program to AF's Walk with Ease (WWE) EX intervention on improved mobility in knee osteoarthritis (OA) patients.
Secondary Aim: To compare the cost effectiveness and effects of the EX+DWL and WWE interventions on weight loss, pain, and quality of life.
Tipo de estudio
Intervencionista
Inscripción (Actual)
227
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- The Ohio State University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
50 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Diagnosed with knee OA: physician documented radiographic tibiofemoral OA of one or both knees
- Overweight or Obese: BMI >25 and <40
- Knee Pain and Risk for Mobility Disability: self-reported difficulty walking ¼ mile, climbing stairs, lifting or carrying groceries, or performing other household activities due to knee pain
- Sedentary: sedentary lifestyle defined as currently participating < 20 minutes of weekly structured moderate intensity exercise occurring in bouts >10 min
- Health Status: all participants must be free of severe heart or systemic disease that would make moderate intensity exercise participation unsafe
- Age: > 50 years of age
- Stability of Residence: does not plan to move out of the Columbus metropolitan area for the duration of the study
- Consents: willing to give an informed consent and sign a HIPPA authorization form; (9) Physician Consent: treating rheumatologist and primary care physician provide medical consent for participation
- Agreeableness: willing to accept randomization and complete all assessment and intervention procedures
Exclusion Criteria:
- Health Status: any serious medical condition that precludes safe participation in an exercise program
- Study Staff Judgment: Inability to complete the study protocol, in the opinion of the study staff, due to frailty, illness, or other reasons
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Exercise and Dietary Weight Loss
For the first 6 months, participants will meet at a community center for 3 group-based sessions and 1 individual session each month.
Sessions include a 45 minute exercise component and a 45 minute dietary weight loss component.
Exercise will consist of progressive aerobic and strength training.
The dietary component will focus on decreasing caloric intake, while being nutritionally safe.
All diets will be monitored by a Registered Dietitian.
During months 7-12, participants will meet for 1 group session and 1 individual session per month.
The final 12-24 months, bimonthly phone calls are provided to the participants to aid in retention efforts.
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The EX+DWL intervention consists of group and individual exercise sessions, as well as, nutritional and dietary counseling.
Bimonthly phone calls are made in the final year of the study to aid in maintenance of the program.
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Comparador activo: Walk with Ease
The Arthritis Foundation's (AF) WWE is a self-management program for symptoms of arthritis (pain, fatigue, stiffness,etc.) through exercise.
It is a 6 week program involving 3 sessions per week each lasting about 60 minutes.
The WWE sessions are comprised of walking, stretching and strengthening exercises, and health education lectures.
These group classes will be lead by an AF instructor.
Each participant will complete 2 consecutive WWE classes for a total of 12 weeks in the program.
During the final week of the program, participants will be trained and transitioin to the self-directed version of WWE for maintenance of exercise.
To aid in retention efforts, phone contacts are provided to participants on a monthly basis from 4-12 months and bi-monthly from 12 to 24 months
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The WWE 6 week program consists of health education lectures on arthritis self-management, a walking exercise portion, and at- home strength exercises.
Participants will complete two consecutive WWE programs.
Monthly and bimonthly phone calls are made to participants in months 4-12 and 12-24, respectively, to aid in maintenance of the program.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mobility Disability
Periodo de tiempo: baseline up to 2 years
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This will be assessed using the 400 meter walk test (400MWT), which is the time to complete 400m as quickly as possible (without running)
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baseline up to 2 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Anthropometric Battery
Periodo de tiempo: baseline up to 2 years
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Body weight and height are used to calculate Body Mass Index (BMI).
Body composition will be assessed using DEXA scans.
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baseline up to 2 years
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Functional Battery and Limitations
Periodo de tiempo: baseline up to 2 years
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Stair-climb time (SCT) is a functional performance measure that involves ascending and descending a flight of 5 stairs as quickly as possible.
Limitations will be assessed using the Pepper Assessment Tool for Disability.
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baseline up to 2 years
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Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Periodo de tiempo: baseline up to two years
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Scale of 0 (none) to 4 (extreme) indicating the amount of difficulty they have experienced performing basic physical function tasks in the past 48 hours due to knee OA.
The physical function subscale consists of 17 items that will be summed to produce a physical function score.
Higher scores indicating poorer function
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baseline up to two years
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Rand Medical Outcomes Study 36-item Short Form Health Survey (SF-36)
Periodo de tiempo: baseline up to two years
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Health related quality of life survey consisting of mental and physical health with subscales of physical functioning, mental health, role-physical, role-emotional, bodily pain, general health, vitality, and social functioning
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baseline up to two years
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Dietary intake
Periodo de tiempo: baseline up to two years
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Dietary intake will be assessed by a registered dietician using the Daily food record measure.
One weekend and 2 weekdays will be assessed.
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baseline up to two years
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Social Cognitive Process Measures
Periodo de tiempo: baseline up to two years
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Physical activity barriers self-efficacy scale, Satisfaction with function and appearance scale, Multiple exercise self-regulatory self-efficacy scale, the weight efficacy lifestyle questionnaire (WEL), goal commitment and goal difficulty, arthritis self-efficacy, and pain acceptance.
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baseline up to two years
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Change in physical activity
Periodo de tiempo: baseline up to two years
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Physical activity will be assessed using the Community Healthy Activities Model Program For Seniors (CHAMPS) and Lifecorder EX Accelerometer
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baseline up to two years
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Cost effectiveness
Periodo de tiempo: baseline up to two years
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The cost-effectiveness of the EX+DWL intervention compared to the WWE [program will be calculated as the ratio of additional cost per participant per increment of effectiveness.
Effectiveness is based on improvement in the 400 MWT and the Quality of Well-being Scale- Self Administered (to calculate the Quality Adjusted Life Years).
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baseline up to two years
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Brian Focht, PhD, Ohio State University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 2016
Finalización primaria (Actual)
1 de abril de 2022
Finalización del estudio (Actual)
1 de abril de 2022
Fechas de registro del estudio
Enviado por primera vez
13 de julio de 2016
Primero enviado que cumplió con los criterios de control de calidad
13 de julio de 2016
Publicado por primera vez (Estimar)
18 de julio de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de octubre de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
10 de octubre de 2022
Última verificación
1 de octubre de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2015H0394
- R01AG050725 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .