Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07585409

Physical Activity in Persons With Parkinson's Disease

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

PARKINSON DISEASE (Disorder) Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Motor Activity Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Physical Activity Sedentary Behavior Sedentary Behaviors Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Physical activity - low and moderate intensity

    Time frame: 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.

Secondary outcomes

  1. Physical activity - total vector magnitude

    Time frame: 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.

  2. Physical activity - low intensity

    Time frame: 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.

  3. Physical activity - moderate high intensity

    Time frame: 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.

  4. Physical activity- sedentary

    Time frame: 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.

  5. Physical activity - steps

    Time frame: 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.

Other outcomes

  1. Disease severity, Parkinsons symptoms

    Time frame: 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

  2. Gait

    Time frame: Baseline and 3 year follow-up

    Gait speed in m/s measured with the 10 meter walking test or through gait analysis.

  3. Balance performance

    Time frame: 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

  4. Anxiety and depression

    Time frame: 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

  5. Cognitive performance

    Time frame: Baseline and 3 year follow-up

    Assessed with the Montreal Cognitive Assessment (MoCA), 0-25, higher score = better

  6. Motivation

    Time frame: 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

  7. Self-efficacy

    Time frame: 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

  8. Physical activity history and preferences,

    Time frame: Baseline

    Self-made questions on physical activity history and preferences

  9. Self assessed cognitive function

    Time frame: 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

  10. Non-Motor Symptoms

    Time frame: 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

  11. Walking ability- self rated

    Time frame: 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)

  12. Freezing of gait - self-assessed

    Time frame: Baseline and 3 year follow-up

    Freezing of gait questionnaire (FOGQsa), 6 questions/items, scored 1 to 5 (higher=worse)

  13. Balance confidence

    Time frame: 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

  14. Fatigue

    Time frame: 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.

  15. Disability

    Time frame: 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

  16. Sleep

    Time frame: 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

  17. Self-rated pain

    Time frame: Baseline and yearly follow-ups for 3 years

    Assessed with visual analog scale, VAS from 0 to 100

  18. Health related quality of life

    Time frame: 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

  19. Wellbeing

    Time frame: 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

  20. Nutrition

    Time frame: Baseline and 3 year follow-up

    Mini Nutritional Assessment, max 14. higher = better

  21. Socioeconomic status

    Time frame: Baseline

    Education and income level.

Study contacts

Contact information is provided by the study sponsor or research team.

Compliance Office Karolinska Insitutet

CONTACT

[email protected]

+46852480000

Erika Franzén

CONTACT

[email protected]

+46852488878

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

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

Registry information

Official study title

Physical Activity in Persons With Parkinson's Disease - a Longitudinal Cohort Study

Acronym: ActivPARK

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
May 13, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.