Physical Activity in Persons With Parkinson's Disease (ActivPARK)
13. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Studietype
Observasjonsmessig
Registrering (Antatt)
450
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Compliance Office Karolinska Insitutet
- Telefonnummer: +46852480000
- E-post: compliance@ki.se
Studer Kontakt Backup
- Navn: Erika Franzén
- Telefonnummer: +46852488878
- E-post: erika.franzen@ki.se
Studiesteder
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-
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Stockholm, Sverige
- Rekruttering
- Karolinska University Hospital
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Ta kontakt med:
- Erika Franzén, PhD
- Telefonnummer: +46852488878
- E-post: erika.franzen@ki.se
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Ta kontakt med:
- LIsa Sandberg, MSc
- E-post: lisa.sandberg@ki.se
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
People with Parkinson's disease with mild to severe severity (Hoehn & Yahr 1-4) of all ages
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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People with Parkinson´'s disease
No intervention
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Physical activity - low and moderate intensity
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Physical activity - total vector magnitude
Tidsramme: 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
Tidsramme: 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.
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Baseline and yearly follow-ups for 3 years
|
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Physical activity - moderate high intensity
Tidsramme: 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.
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Baseline and yearly follow-ups for 3 years
|
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Physical activity- sedentary
Tidsramme: 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.
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Baseline and yearly follow-ups for 3 years
|
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Physical activity - steps
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Kognitiv ytelse
Tidsramme: Baseline og 3 års oppfølging
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Vurdert med Montreal Cognitive Assessment (MOCA), 0-25, høyere poengsum = bedre
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Baseline og 3 års oppfølging
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Disease severity, Parkinsons symptoms
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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Baseline and yearly follow-ups for 3 years
|
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Physical activity history and preferences,
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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Baseline and yearly follow-ups for 3 years
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Wellbeing
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline
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Education and income level.
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Baseline
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Erika Franzén, Karolinska Institutet
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. januar 2026
Primær fullføring (Antatt)
31. desember 2030
Studiet fullført (Antatt)
30. januar 2031
Datoer for studieregistrering
Først innsendt
7. mai 2026
Først innsendt som oppfylte QC-kriteriene
7. mai 2026
Først lagt ut (Faktiske)
13. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 4-438/2024
- 2024-07526-01 (Annen identifikator: Swedish Ethical Review Authority)
- 06901869 (Annen identifikator: Clinical Trials registration -pilot study)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
We plan to share this when applicable on OSF or similar
Tilgangskriterier for IPD-deling
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-deling Støtteinformasjonstype
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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