Physical Activity in Persons With Parkinson's Disease (ActivPARK)
13 de maio de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Tipo de estudo
Observacional
Inscrição (Estimado)
450
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Compliance Office Karolinska Insitutet
- Número de telefone: +46852480000
- E-mail: compliance@ki.se
Estude backup de contato
- Nome: Erika Franzén
- Número de telefone: +46852488878
- E-mail: erika.franzen@ki.se
Locais de estudo
-
-
-
Stockholm, Suécia
- Recrutamento
- Karolinska University Hospital
-
Contato:
- Erika Franzén, PhD
- Número de telefone: +46852488878
- E-mail: erika.franzen@ki.se
-
Contato:
- LIsa Sandberg, MSc
- E-mail: lisa.sandberg@ki.se
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra Não Probabilística
População do estudo
People with Parkinson's disease with mild to severe severity (Hoehn & Yahr 1-4) of all ages
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
|
People with Parkinson´'s disease
No intervention
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Physical activity - low and moderate intensity
Prazo: Baseline and yearly follow-ups for 3 years
|
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.
|
Baseline and yearly follow-ups for 3 years
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Physical activity - total vector magnitude
Prazo: Baseline and yearly follow-ups for 3 years
|
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.
|
Baseline and yearly follow-ups for 3 years
|
|
Physical activity - low intensity
Prazo: Baseline and yearly follow-ups for 3 years
|
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.
|
Baseline and yearly follow-ups for 3 years
|
|
Physical activity - moderate high intensity
Prazo: Baseline and yearly follow-ups for 3 years
|
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.
|
Baseline and yearly follow-ups for 3 years
|
|
Physical activity- sedentary
Prazo: Baseline and yearly follow-ups for 3 years
|
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.
|
Baseline and yearly follow-ups for 3 years
|
|
Physical activity - steps
Prazo: Baseline and yearly follow-ups for 3 years
|
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.
|
Baseline and yearly follow-ups for 3 years
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Desempenho cognitivo
Prazo: Linha de base e acompanhamento de 3 anos
|
Avaliado com a avaliação cognitiva de Montreal (MOCA), 0-25, pontuação mais alta = melhor
|
Linha de base e acompanhamento de 3 anos
|
|
Disease severity, Parkinsons symptoms
Prazo: Baseline and 3 year follow-up
|
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
|
|
Gait
Prazo: Baseline and 3 year follow-up
|
Gait speed in m/s measured with the 10 meter walking test or through gait analysis.
|
Baseline and 3 year follow-up
|
|
Balance performance
Prazo: Baseline and 3 year follow-up
|
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
|
Baseline and 3 year follow-up
|
|
Anxiety and depression
Prazo: Baseline and yearly follow-ups for 3 years
|
Assessed with Hospital Anxiety and Depression Scale (HADS), 0-24 on the depression and anxiety part respectively.
Lower score=better
|
Baseline and yearly follow-ups for 3 years
|
|
Motivation
Prazo: Baseline and yearly follow-ups for 3 years
|
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
|
Baseline and yearly follow-ups for 3 years
|
|
Self-efficacy
Prazo: Baseline and yearly follow-ups for 3 years
|
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
|
Baseline and yearly follow-ups for 3 years
|
|
Physical activity history and preferences,
Prazo: Baseline
|
Self-made questions on physical activity history and preferences
|
Baseline
|
|
Self assessed cognitive function
Prazo: Baseline and yearly follow-ups for 3 years
|
Assessed with Executive function questionnaire (DEX), 20 items scored 1 to 4, max 80, more scores= worse
|
Baseline and yearly follow-ups for 3 years
|
|
Non-Motor Symptoms
Prazo: Baseline and yearly follow-ups for 3 years
|
Non-Motor Symptoms Questionnaire (NMSQ), 30 questions with yes/no answer.
More yes answers = more non-motor symptoms
|
Baseline and yearly follow-ups for 3 years
|
|
Walking ability- self rated
Prazo: Baseline and yearly follow-ups for 3 years
|
WALK-12G questionnaire, 0 and 42 points, with higher scores reflecting greater perceived walking difficulties (higher=worse)
|
Baseline and yearly follow-ups for 3 years
|
|
Freezing of gait - self-assessed
Prazo: Baseline and 3 year follow-up
|
Freezing of gait questionnaire (FOGQsa), 6 questions/items, scored 1 to 5 (higher=worse)
|
Baseline and 3 year follow-up
|
|
Balance confidence
Prazo: Baseline and yearly follow-ups for 3 years
|
Activities specific balance confidence (ABC scale), 16 items which is scored 1 to 10 and then divided by 16. 0-100%, higher % = better
|
Baseline and yearly follow-ups for 3 years
|
|
Fatigue
Prazo: Baseline and yearly follow-ups for 3 years
|
Parkinson's Fatigue Scale (PFS-16), 16 items scored 1 to 5 from strongly disagree to strongly agree .
more points/score= worse.
|
Baseline and yearly follow-ups for 3 years
|
|
Disability
Prazo: Baseline and 3 year follow-up
|
World health organization (WHO) disability assessment schedule (Whodas 2.0), 12 self-assessed questions (12 to 60) more points=worse
|
Baseline and 3 year follow-up
|
|
Sleep
Prazo: Baseline and 3 year follow-up
|
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
|
Baseline and 3 year follow-up
|
|
Self-rated pain
Prazo: Baseline and yearly follow-ups for 3 years
|
Assessed with visual analog scale, VAS from 0 to 100
|
Baseline and yearly follow-ups for 3 years
|
|
Health related quality of life
Prazo: Baseline and yearly follow-ups for 3 years
|
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
|
Baseline and yearly follow-ups for 3 years
|
|
Wellbeing
Prazo: Baseline and yearly follow-ups for 3 years
|
The WHO- Five Well-Being Index (WHO-5), 5 questions ranging from 0 to 5, 0-25, higher=better
|
Baseline and yearly follow-ups for 3 years
|
|
Nutrition
Prazo: Baseline and 3 year follow-up
|
Mini Nutritional Assessment, max 14. higher = better
|
Baseline and 3 year follow-up
|
|
Socioeconomic status
Prazo: Baseline
|
Education and income level.
|
Baseline
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Erika Franzén, Karolinska Institutet
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
15 de janeiro de 2026
Conclusão Primária (Estimado)
31 de dezembro de 2030
Conclusão do estudo (Estimado)
30 de janeiro de 2031
Datas de inscrição no estudo
Enviado pela primeira vez
7 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de maio de 2026
Primeira postagem (Real)
13 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
15 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
13 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 4-438/2024
- 2024-07526-01 (Outro identificador: Swedish Ethical Review Authority)
- 06901869 (Outro identificador: Clinical Trials registration -pilot study)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Prazo de Compartilhamento de IPD
We plan to share this when applicable on OSF or similar
Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD
- SEIVA
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .