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

13. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

450

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Compliance Office Karolinska Insitutet
  • Telefonnummer: +46852480000
  • E-mail: compliance@ki.se

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
People with Parkinson´'s disease
No intervention

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Foranstaltningsbeskrivelse
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.
Baseline and yearly follow-ups for 3 years
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.
Baseline and yearly follow-ups for 3 years
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.
Baseline and yearly follow-ups for 3 years
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.
Baseline and yearly follow-ups for 3 years
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.
Baseline and yearly follow-ups for 3 years

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Kognitiv præstation
Tidsramme: Baseline og 3 års opfølgning
Vurderet med Montreal Cognitive Assessment (MOCA), 0-25, Højere score = bedre
Baseline og 3 års opfølgning
Disease severity, Parkinsons symptoms
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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
Baseline and yearly follow-ups for 3 years
Physical activity history and preferences,
Tidsramme: Baseline
Self-made questions on physical activity history and preferences
Baseline
Self assessed cognitive function
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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
Baseline and yearly follow-ups for 3 years
Wellbeing
Tidsramme: 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
Tidsramme: Baseline and 3 year follow-up
Mini Nutritional Assessment, max 14. higher = better
Baseline and 3 year follow-up
Socioeconomic status
Tidsramme: Baseline
Education and income level.
Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Karolinska Institutet

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: Erika Franzén, Karolinska Institutet

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. januar 2026

Primær færdiggørelse (Anslået)

31. december 2030

Studieafslutning (Anslået)

30. januar 2031

Datoer for studieregistrering

Først indsendt

7. maj 2026

Først indsendt, der opfyldte QC-kriterier

7. maj 2026

Først opslået (Faktiske)

13. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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

IPD-delingsadgangskriterier

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 Understøttende informationstype

  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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