Physical Activity in Persons With Parkinson's Disease (ActivPARK)
13 mei 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Studietype
Observationeel
Inschrijving (Geschat)
450
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Compliance Office Karolinska Insitutet
- Telefoonnummer: +46852480000
- E-mail: compliance@ki.se
Studie Contact Back-up
- Naam: Erika Franzén
- Telefoonnummer: +46852488878
- E-mail: erika.franzen@ki.se
Studie Locaties
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Stockholm, Zweden
- Werving
- Karolinska University Hospital
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Contact:
- Erika Franzén, PhD
- Telefoonnummer: +46852488878
- E-mail: erika.franzen@ki.se
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Contact:
- LIsa Sandberg, MSc
- E-mail: lisa.sandberg@ki.se
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
People with Parkinson's disease with mild to severe severity (Hoehn & Yahr 1-4) of all ages
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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People with Parkinson´'s disease
No intervention
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Physical activity - low and moderate intensity
Tijdsspanne: 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.
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Baseline and yearly follow-ups for 3 years
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Physical activity - total vector magnitude
Tijdsspanne: 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.
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Baseline and yearly follow-ups for 3 years
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Physical activity - low intensity
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
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Baseline and yearly follow-ups for 3 years
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Cognitieve prestaties
Tijdsspanne: Basislijn en 3 jaar follow-up
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Beoordeeld met de Montreal Cognitive Assessment (MOCA), 0-25, hogere score = beter
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Basislijn en 3 jaar follow-up
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Disease severity, Parkinsons symptoms
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
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Baseline and yearly follow-ups for 3 years
|
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Motivation
Tijdsspanne: 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
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Baseline and yearly follow-ups for 3 years
|
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Self-efficacy
Tijdsspanne: 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,
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
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Baseline and yearly follow-ups for 3 years
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Fatigue
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline
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Education and income level.
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Baseline
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Erika Franzén, Karolinska Institutet
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
15 januari 2026
Primaire voltooiing (Geschat)
31 december 2030
Studie voltooiing (Geschat)
30 januari 2031
Studieregistratiedata
Eerst ingediend
7 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
7 mei 2026
Eerst geplaatst (Werkelijk)
13 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
15 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
13 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 4-438/2024
- 2024-07526-01 (Andere identificatie: Swedish Ethical Review Authority)
- 06901869 (Andere identificatie: Clinical Trials registration -pilot study)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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.
IPD-tijdsbestek voor delen
We plan to share this when applicable on OSF or similar
IPD-toegangscriteria voor delen
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.
IPD delen Ondersteunend informatietype
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .