Physical Activity in Persons With Parkinson's Disease (ActivPARK)
13 de mayo de 2026 actualizado por: Erika Franzén, Karolinska Institutet
Physical Activity in Persons With Parkinson's Disease - a Longitudinal Cohort Study
This project aims to identify why some people with Parkinson's disease (PwPD) become less physically active, and which factors support or hinder activity. Understanding these factors is essential for developing person centred interventions and effective support that can be implemented in routine healthcare. A national, multicentre longitudinal cohort study will be conducted including approx 450 PwPD from five Swedish regions (including the internal pilot NCT06901869). Physical activity will be measured objectively with activity monitors, combined with clinical assessments and digital questionnaires over four years. The primary outcome is physical activity level (accelerometer measured decline), and exposure variables include physical, cognitive, disease specific, social, environmental, motivational, and personal factors. Data collection involves clinical tests, questionnaires, accelerometer data, and patient reported experiences.
This is a continuation of an internal pilot study NCT06901869. The study will enable early identification of those at risk for declining activity and guide development of person centred, evidence based interventions. Long term, it aims to integrate activity monitoring and risk factor screening into routine care to improve health and quality of life for PwPD.
Descripción general del estudio
Estado
Reclutamiento
Tipo de estudio
De observación
Inscripción (Estimado)
450
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: Compliance Office Karolinska Insitutet
- Número de teléfono: +46852480000
- Correo electrónico: compliance@ki.se
Copia de seguridad de contactos de estudio
- Nombre: Erika Franzén
- Número de teléfono: +46852488878
- Correo electrónico: erika.franzen@ki.se
Ubicaciones de estudio
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Stockholm, Suecia
- Reclutamiento
- Karolinska University Hospital
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Contacto:
- Erika Franzén, PhD
- Número de teléfono: +46852488878
- Correo electrónico: erika.franzen@ki.se
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Contacto:
- LIsa Sandberg, MSc
- Correo electrónico: lisa.sandberg@ki.se
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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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
People with Parkinson's disease with mild to severe severity (Hoehn & Yahr 1-4) of all ages
Descripción
Inclusion Criteria:
- People diagnosed with idiopathic Parkinson's disease
- Hoehn & Yahr 1 to 4
Exclusion Criteria:
- Hoehn & Yahr 5 (i.e. wheelchair bound or bedridden unless aided)
- Unable to perform critical physical activity and clinical assessments
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
Cohortes e Intervenciones
Grupo / Cohorte |
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People with Parkinson´'s disease
No intervention
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Physical activity - low and moderate intensity
Periodo de tiempo: Baseline and yearly follow-ups for 3 years
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The primary outcome is changes over time in PA (i.e.
low + moderate-vigorous intensity PA in time spent per day) measured with accelerometers (Actigraph GT3X+, Pensacola, FL, US) during 7 days in people with Parkinson's disease everyday life.
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Baseline and yearly follow-ups for 3 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Physical activity - total vector magnitude
Periodo de tiempo: Baseline and yearly follow-ups for 3 years
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The secondary outcomes are change over time in total vector magnitude measured with accelerometers (Actigraph GT3X+, Pensacola, FL, US) during 7 days in people with Parkinson's disease everyday life.
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Baseline and yearly follow-ups for 3 years
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Physical activity - low intensity
Periodo de tiempo: Baseline and yearly follow-ups for 3 years
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The secondary outcomes are change in time spent in low intensity physical activity per day measured with accelerometers (Actigraph GT3X+, Pensacola, FL, US) during 7 days in people with Parkinson's disease everyday life.
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Baseline and yearly follow-ups for 3 years
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Physical activity - moderate high intensity
Periodo de tiempo: Baseline and yearly follow-ups for 3 years
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The secondary outcomes are change in time spent in moderate-vigorous physical activity per day measured with accelerometers (Actigraph GT3X+, Pensacola, FL, US) during 7 days in people with Parkinson's disease everyday life.
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Baseline and yearly follow-ups for 3 years
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Physical activity- sedentary
Periodo de tiempo: Baseline and yearly follow-ups for 3 years
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The secondary outcomes are change in sedentary time per day measured with accelerometers (Actigraph GT3X+, Pensacola, FL, US) during 7 days in people with Parkinson's disease everyday life.
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Baseline and yearly follow-ups for 3 years
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Physical activity - steps
Periodo de tiempo: Baseline and yearly follow-ups for 3 years
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The secondary outcomes are change in steps per day measured with accelerometers (Actigraph GT3X+, Pensacola, FL, US) during 7 days in people with Parkinson's disease everyday life.
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Baseline and yearly follow-ups for 3 years
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rendimiento cognitivo
Periodo de tiempo: Línea de base y seguimiento de 3 años
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Evaluado con la evaluación cognitiva de Montreal (MOCA), 0-25, puntaje más alto = mejor
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Línea de base y seguimiento de 3 años
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Disease severity, Parkinsons symptoms
Periodo de tiempo: Baseline and 3 year follow-up
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Disease severity measured with the Movement Disorders Society -Unified Parkinson's Disease Rating Scale) parts 1 to 4. Higher scores = worse/more symptoms |
Baseline and 3 year follow-up
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Gait
Periodo de tiempo: Baseline and 3 year follow-up
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Gait speed in m/s measured with the 10 meter walking test or through gait analysis.
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Baseline and 3 year follow-up
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Balance performance
Periodo de tiempo: Baseline and 3 year follow-up
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Assessed with the Mini-BESTest.
Mini-Balance Evaluation Systems Test a rating scale for dynamic balance incorporating 14 different balance and gait items that were assessed by a physical therapist on a scale from 0-2. 0-28 points with higher scores indicating better balance control
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Baseline and 3 year follow-up
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Anxiety and depression
Periodo de tiempo: Baseline and yearly follow-ups for 3 years
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Assessed with Hospital Anxiety and Depression Scale (HADS), 0-24 on the depression and anxiety part respectively.
Lower score=better
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Baseline and yearly follow-ups for 3 years
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Motivation
Periodo de tiempo: Baseline and yearly follow-ups for 3 years
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Assessed with the Behavioural Regulation in Exercise Questionnaire (BREQ 4), a 28-item survey that measures exercise motivation.
The questionnaire uses a 7-point Likert scale, ranging from one to seven.
Maximum 196.
Higher scores = higher motivation
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Baseline and yearly follow-ups for 3 years
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Self-efficacy
Periodo de tiempo: Baseline and yearly follow-ups for 3 years
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Assessed with the Self-efficacy and motivation for exercise/physical activity (ESES).
10 questions rated on a 4 point Likert scale.
Maximun 40 points, higher scores= better self-efficacy
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Baseline and yearly follow-ups for 3 years
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Physical activity history and preferences,
Periodo de tiempo: Baseline
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Self-made questions on physical activity history and preferences
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Baseline
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Self assessed cognitive function
Periodo de tiempo: Baseline and yearly follow-ups for 3 years
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Assessed with Executive function questionnaire (DEX), 20 items scored 1 to 4, max 80, more scores= worse
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Baseline and yearly follow-ups for 3 years
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Non-Motor Symptoms
Periodo de tiempo: Baseline and yearly follow-ups for 3 years
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Non-Motor Symptoms Questionnaire (NMSQ), 30 questions with yes/no answer.
More yes answers = more non-motor symptoms
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Baseline and yearly follow-ups for 3 years
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Walking ability- self rated
Periodo de tiempo: Baseline and yearly follow-ups for 3 years
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WALK-12G questionnaire, 0 and 42 points, with higher scores reflecting greater perceived walking difficulties (higher=worse)
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Baseline and yearly follow-ups for 3 years
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Freezing of gait - self-assessed
Periodo de tiempo: Baseline and 3 year follow-up
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Freezing of gait questionnaire (FOGQsa), 6 questions/items, scored 1 to 5 (higher=worse)
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Baseline and 3 year follow-up
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Balance confidence
Periodo de tiempo: Baseline and yearly follow-ups for 3 years
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Activities specific balance confidence (ABC scale), 16 items which is scored 1 to 10 and then divided by 16. 0-100%, higher % = better
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Baseline and yearly follow-ups for 3 years
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Fatigue
Periodo de tiempo: Baseline and yearly follow-ups for 3 years
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Parkinson's Fatigue Scale (PFS-16), 16 items scored 1 to 5 from strongly disagree to strongly agree .
more points/score= worse.
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Baseline and yearly follow-ups for 3 years
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Disability
Periodo de tiempo: Baseline and 3 year follow-up
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World health organization (WHO) disability assessment schedule (Whodas 2.0), 12 self-assessed questions (12 to 60) more points=worse
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Baseline and 3 year follow-up
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Sleep
Periodo de tiempo: Baseline and 3 year follow-up
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Scales for Outcomes in Parkinson's disease - Sleep (SCOPA-SLEEP), 4 parts, A-2 questions, B-5 questions , C-1 question and D- 6 questions.
Higher= worse
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Baseline and 3 year follow-up
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Self-rated pain
Periodo de tiempo: Baseline and yearly follow-ups for 3 years
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Assessed with visual analog scale, VAS from 0 to 100
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Baseline and yearly follow-ups for 3 years
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Health related quality of life
Periodo de tiempo: Baseline and yearly follow-ups for 3 years
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Parkinson's Disease Questionnaire (PDQ39).
The Parkinson's Disease Questionnaire (PDQ-39) assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living (mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communications and bodily discomfort).
The sum score is as a percentage score ranging between 0 and 100.
Higher is better
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Baseline and yearly follow-ups for 3 years
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Wellbeing
Periodo de tiempo: Baseline and yearly follow-ups for 3 years
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The WHO- Five Well-Being Index (WHO-5), 5 questions ranging from 0 to 5, 0-25, higher=better
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Baseline and yearly follow-ups for 3 years
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Nutrition
Periodo de tiempo: Baseline and 3 year follow-up
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Mini Nutritional Assessment, max 14. higher = better
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Baseline and 3 year follow-up
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Socioeconomic status
Periodo de tiempo: Baseline
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Education and income level.
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Baseline
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Erika Franzén, Karolinska Institutet
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 (Actual)
15 de enero de 2026
Finalización primaria (Estimado)
31 de diciembre de 2030
Finalización del estudio (Estimado)
30 de enero de 2031
Fechas de registro del estudio
Enviado por primera vez
7 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
7 de mayo de 2026
Publicado por primera vez (Actual)
13 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
13 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Sinucleinopatías
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades neurodegenerativas
- Trastornos del movimiento
- Trastornos Parkinsonianos
- Enfermedades de los ganglios basales
- Comportamiento
- Enfermedad de Parkinson
- Actividad del motor
- Comportamiento sedentario
Otros números de identificación del estudio
- 4-438/2024
- 2024-07526-01 (Otro identificador: Swedish Ethical Review Authority)
- 06901869 (Otro identificador: Clinical Trials registration -pilot study)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
The datasets generated during and/or analysed during the current study are not publicly available due to Swedish and EU personal data legislation but are available from the principal investigator on reasonable request.
Any sharing of data will be regulated via a data transfer and user agreement with the recipient, provided that the recipient has an approved ethics application.
Marco de tiempo para compartir IPD
We plan to share this when applicable on OSF or similar
Criterios de acceso compartido de IPD
The datasets generated during and/or analysed during the current study are not publicly available due to Swedish and EU personal data legislation but are available from the principal investigator on reasonable request.
Any sharing of data will be regulated via a data transfer and user agreement with the recipient.
Tipo de información de apoyo para compartir IPD
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .