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Using Personalized Rehabilitation to Reduce Disease and Increase Activity of Patients With Polymyalgia Rheumatica

4 de agosto de 2026 actualizado por: Washington University School of Medicine

Using Personalized Rehabilitation to Reduce Disease and Increase Activity of Patients With Polymyalgia Rheumatica: a Feasibility Randomized Clinical Trial

Polymyalgia rheumatica (PMR) is a condition that causes joint pain and stiffness, making it hard for people to do everyday tasks. Movement pattern training is a special, personalized rehabilitation program that aims to reduce pain by improving how people move during their daily activities. The investigators plan to test if it's possible to conduct a detailed study to find out how effective Movement pattern training is for people with PMR. The investigators will look at whether it helps them perform activities they want to do, reduce their use of certain medications, and strengthen their muscles. The investigators will also gather feedback from patients about their experience with Movement pattern training. This study will help us understand if carrying out a larger study on Movement pattern training's effectiveness is practical.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Polimialgia reumática (PMR)

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

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.

Estudio Contacto

Nombre: Marcie Harris-Hayes, DPT, MSCI
Número de teléfono: 314-286-1435
Correo electrónico: harrisma@wustl.edu

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

Adulto
Adulto Mayor

Acepta Voluntarios Saludables

Descripción

Inclusion Criteria:

Patient reports a diagnosis or flare of polymyalgia rheumatica (PMR) < 5 months before the screening contact
Diagnosis or flare of PMR according to the European League against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria as follows (must satisfy all criteria)10:
- Age ≥50 years at time of diagnosis
- Presence of bilateral shoulder pain
- Elevated acute phase reactants C-reactive protein (CRP) >10 milligram/Liter and/or Erythrocyte Sedimentation Rate (ESR) >30 millimeters/hour*
- A score ≥4 at the time of diagnosis based on the following (without ultrasound):
  - Duration of morning stiffness >45 minutes: 2 points
  - Hip pain or limited range of motion: 1 point
  - Seronegative for rheumatoid factor and anti-cyclic citrullinated peptide: 2 points
  - Absence of other joint involvement: 1 point
Initiated pharmacological treatment
Able to give informed consent
Physician's clearance to participate in physical activity

Exclusion Criteria:

Diagnosis of fibromyalgia, neuropathic muscular disease, complex regional pain syndrome, or small fiber neuropathy
planned major surgical procedure during the study
Current active uncontrolled infection

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: Otro
Asignación: Aleatorizado
Modelo Intervencionista: Asignación paralela
Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo Grupo de participantes/brazo Un grupo o subgrupo de participantes en un ensayo clínico que recibe una intervención/tratamiento específico, o ninguna intervención, según el protocolo del ensayo.	Intervención / Tratamiento Intervención / Tratamiento Un proceso o acción que es el foco de un estudio clínico. Las intervenciones incluyen medicamentos, dispositivos médicos, procedimientos, vacunas y otros productos que están en fase de investigación o que ya están disponibles. Las intervenciones también pueden incluir enfoques no invasivos, como la educación o la modificación de la dieta y el ejercicio.
Comparador activo: Usual Care Patients will be encouraged to complete their treatment as described by their physician.	Otro: Usual Care Basic education about polymyalgia rheumatica, benefits of physical activity Patients will be encouraged to participate in physical activity as tolerated Medication as prescribed by their physician
Experimental: Movement Pattern Training (MoveTrain) Movement pattern Training (MoveTrain) is progressive activity-specific training to improve altered joint motion during patient-specific tasks. At baseline, each patient identifies specific activities (e.g., getting out of bed), work (e.g., reaching overhead), and physical activities (e.g., cycling) that are difficult due to their pain. A movement examination is performed to identify the altered joint motion on associated with movement-evoked pain and the motion modification that reduces their pain. The treatment provider then instructs the patient in activity-specific training, which includes practicing multiple repetitions of the modified activity as their home exercise program. Patients also are instructed to use the trained modified motion during their daily activities to maximize their use in daily routines. This encourages frequent practice and potentially greater program sustainability.	Conductual: Movement Pattern Training (MoveTrain) 6 individualized treatment sessions over 10 weeks Motivational interviewing to determine personal goals and strengthen motivation and commitment to change Activity-specific training to practice modified motion during patient-specific tasks, defined as activities reported by each patient as pain-provoking Home exercise program 3 times/week consisting of activities or exercises assigned in the supervised sessions Patient's independence and adherence in performing home exercise program will be documented Patients are encouraged to use modified motion during daily and physical activities Based on patient performance, activity difficulty is progressed by increasing repetitions performed or increasing load or speed

Grupo de participantes/brazo

Intervención / Tratamiento

Comparador activo: Usual Care

Patients will be encouraged to complete their treatment as described by their physician.

Otro: Usual Care

Basic education about polymyalgia rheumatica, benefits of physical activity
Patients will be encouraged to participate in physical activity as tolerated
Medication as prescribed by their physician

Experimental: Movement Pattern Training (MoveTrain)

Movement pattern Training (MoveTrain) is progressive activity-specific training to improve altered joint motion during patient-specific tasks. At baseline, each patient identifies specific activities (e.g., getting out of bed), work (e.g., reaching overhead), and physical activities (e.g., cycling) that are difficult due to their pain. A movement examination is performed to identify the altered joint motion on associated with movement-evoked pain and the motion modification that reduces their pain. The treatment provider then instructs the patient in activity-specific training, which includes practicing multiple repetitions of the modified activity as their home exercise program. Patients also are instructed to use the trained modified motion during their daily activities to maximize their use in daily routines. This encourages frequent practice and potentially greater program sustainability.

Conductual: Movement Pattern Training (MoveTrain)

6 individualized treatment sessions over 10 weeks

Motivational interviewing to determine personal goals and strengthen motivation and commitment to change
Activity-specific training to practice modified motion during patient-specific tasks, defined as activities reported by each patient as pain-provoking
Home exercise program 3 times/week consisting of activities or exercises assigned in the supervised sessions
Patient's independence and adherence in performing home exercise program will be documented
Patients are encouraged to use modified motion during daily and physical activities
Based on patient performance, activity difficulty is progressed by increasing repetitions performed or increasing load or speed

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Number of potential participants accessed. Periodo de tiempo: 7 months	The total number of people with Polymyalgia rheumatica (PMR) who were recruited each week	7 months
Percent of eligible participants who were willing to be randomized Periodo de tiempo: 7 months	Percent of eligible participants are willing to be randomized during the study	7 months

Medidas de resultado secundarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Preliminary estimates of change in polymyalgia rheumatica impact scale (PMR-IS) Periodo de tiempo: From enrollment to the end of treatment at 10 weeks	The change in polymyalgia rheumatica impact scale (PMR-IS), a self-report questionnaire specific to polymyalgia rheumatica, that represents the patients symptoms and functional ability.	From enrollment to the end of treatment at 10 weeks
Preliminary estimates of change in physical activity Periodo de tiempo: From enrollment to the end of treatment at 10 weeks	The change in physical activity as represented by the Stanford 7-DAy Physical Activity Recall survey	From enrollment to the end of treatment at 10 weeks
Preliminary estimates of change in cumulative glucocorticoid dose Periodo de tiempo: From enrollment to the end of treatment at 10 weeks	Change in cumulative glucocorticoid dose assessed by patient's self-report logs	From enrollment to the end of treatment at 10 weeks
Preliminary estimates of change in muscle strength Periodo de tiempo: From enrollment to the end of treatment at 10 weeks	change in muscle strength of the hips and shoulders, assessed using a hand dynamometer	From enrollment to the end of treatment at 10 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Washington University School of Medicine

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.

Publicaciones Generales

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 (Estimado)

15 de agosto de 2026

Finalización primaria (Estimado)

31 de marzo de 2027

Finalización del estudio (Estimado)

31 de marzo de 2027

Fechas de registro del estudio

Enviado por primera vez

24 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

4 de agosto de 2026

Publicado por primera vez (Actual)

6 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

202602100

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan IPD

This is a feasibility study with only 20 planned participants with limited budget. There is insufficient support for personnel required to prepare the data for sharing purposes.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Estudia un producto de dispositivo regulado por la FDA 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. .

Using Personalized Rehabilitation to Reduce Disease and Increase Activity of Patients With Polymyalgia Rheumatica