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Physical Activity in Persons With Parkinson's Disease (ActivPARK)

13 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Type d'étude

Observationnel

Inscription (Estimé)

450

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Compliance Office Karolinska Insitutet
  • Numéro de téléphone: +46852480000
  • E-mail: compliance@ki.se

Sauvegarde des contacts de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

People with Parkinson's disease with mild to severe severity (Hoehn & Yahr 1-4) of all ages

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
People with Parkinson´'s disease
No intervention

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Physical activity - low and moderate intensity
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Physical activity - total vector magnitude
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Performance cognitive
Délai: Suivi de base et de 3 ans
Évalué avec l'évaluation cognitive de Montréal (MOCA), 0-25, score plus élevé = meilleur
Suivi de base et de 3 ans
Disease severity, Parkinsons symptoms
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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,
Délai: Baseline
Self-made questions on physical activity history and preferences
Baseline
Self assessed cognitive function
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Baseline and 3 year follow-up
Mini Nutritional Assessment, max 14. higher = better
Baseline and 3 year follow-up
Socioeconomic status
Délai: Baseline
Education and income level.
Baseline

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Karolinska Institutet

Collaborateurs

Lund University
Göteborg University
Umeå University
Vastra Gotaland Region
Region Skane
Region Stockholm
Region Västerbotten
Region Norrbotten

Les enquêteurs

  • Chercheur principal: Erika Franzén, Karolinska Institutet

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

15 janvier 2026

Achèvement primaire (Estimé)

31 décembre 2030

Achèvement de l'étude (Estimé)

30 janvier 2031

Dates d'inscription aux études

Première soumission

7 mai 2026

Première soumission répondant aux critères de contrôle qualité

7 mai 2026

Première publication (Réel)

13 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 4-438/2024
  • 2024-07526-01 (Autre identifiant: Swedish Ethical Review Authority)
  • 06901869 (Autre identifiant: Clinical Trials registration -pilot study)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Délai de partage IPD

We plan to share this when applicable on OSF or similar

Critères d'accès au partage 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.

Type d'informations de prise en charge du partage d'IPD

  • SÈVE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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