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NCT Number: NCT06901869

Physical Activity in Persons With Parkinson's Disease

Parkinson's disease (PD) is a leading neurodegenerative health condition in Sweden and a public health concern. Although no cure exists, functional independence and participation in society remain top priorities, and can be achieved through targeted physical activity (PA) interventions. To date, few longitudinal cohort studies have been conducted, using PA as main outcome in therapy research, partly due to the complex nature of predicting and controlling this phenomenon. To help address this knowledge gap, the overall purpose of the future long-term (ActivPARK) study is to enhance knowledge of the evolution of PA behavior, and how it is influenced beyond the disease characteristics using a broad explanatory model, in persons with PD from a diversity of settings in Sweden with the aim of prescribing tailored and personalized interventions to enhance functioning, health, and wellbeing throughout the disease progression and recommend potential health care pathway modifications.

The investigators have just established an expert group, comprising researchers, healthcare professionals, and PD organisations (including persons with PD) and reached consensus on essential priority clinical therapy research questions on PA and methodological considerations. The next phase entails performing a multicentre feasibility/pilot study, further developing and refining the assessment battery and research questions linked to the improved explanatory model for PA and methodology, to inform the definite larger clinical cohort study.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska institutet

Stockholm, Solna, 17177, Sweden

Location status: Recruiting

Location contact

Erika Franzén, PhD

CONTACT

[email protected]

+46852488878

Erika Franzén, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with Parkinson's disease
  • Mild to severe disease severity ( Hoehn & Yahr 1-4).

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Feasibility of the assessment battery - length of the clinical examination and questionnaires

    Time frame: Baseline

    The pilot/feasibility study aims to evaluate feasibility of the assessment battery measured the time it takes to complete the examination and questionnaires.

  2. Feasibility of the assessment battery - perception of the clinical examination

    Time frame: Baseline

    Feasibility of the assessment battery will also be evaluated through semi-structured questions regarding fatique, concentration, pain/discomfort to the participants after the clinical examination.

  3. Feasibility of the assessment battery -Compliance to questionnaires sent via REDCap

    Time frame: Baselline

    Compliance will be measured with percentages of completed questionnaires in REDCap.

  4. Feasibility of the assessment battery - Suitability of the primary outcome

    Time frame: Baseline

    Suitability of the accelerometers in the home environment as the primary outcome for the targeted patient group will be assessed by the percentage of participants that are able to wear the accelerometer for at least 4 days days and render valid data.

  5. Physical activity levels

    Time frame: Baseline

    The ActiGraph accelerometer (GT3X+, ActiGraph, Pensacola, FL, US) will be used to measure absolute and relative time spent in sedentary behavior, low intensity physical activity (LIPA) and moderate to vigorous intensity physical activity (MVPA), by total time in bouts.

Secondary outcomes

  1. Physical activity - self rated

    Time frame: Baseline

    Frändin Grimby scale, ranging from 1 to 6, higher score=better.

  2. Disease severity, Parkinson symptoms

    Time frame: Baseline

    Movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS- UPDRS) parts 1 to 4.

    Higher scores = worse/more symptoms

  3. Gait

    Time frame: Baseline

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

  4. Balance performance

    Time frame: Baseline

    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. Maximum points 28. 0-28 points with higher scores indicating better balance control

  5. Anxiety and depression

    Time frame: Baseline

    Assessed with Hospital Anxiety and Depression Scale (HADS), 0-24 on the depression and anxiety part respectively. Lower score=better

  6. Cognitive performance

    Time frame: Baseline and 3 year follow-up

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

  7. Self assessed cognitive function

    Time frame: Baseline

    Assessed with Executive function questionnaire (DEX), 20 items scored 1 to 4, max 80, more scores= worse.

  8. Non-Motor Symptoms

    Time frame: Baseline

    Non-Motor Symptoms Questionnaire (NMSQ), 30 questions with yes/no answer. More yes answers = more non-motor symptoms

  9. Walking ability- self assessed

    Time frame: Baseline

    WALK-12G questionnaire, 0 and 42 points, with higher scores reflecting greater perceived walking difficulties (higher=worse)

  10. Freezing of gait - self-assessed

    Time frame: Baseline

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

  11. Balance confidence

    Time frame: Baseline

    Activities specific balance confidence (ABC scale), 16 items which is scored 1 to 10 and then divided by 16. 0-100%, higher % = better

  12. Motivation

    Time frame: Baseline

    Behavioural Regulation in Exercise Questionnaire (BREQ 4), 28 items score 1 to 7 and divided into subcomponents: Amotivation, External regulation, Introjected avoidance, Introjected approach, Identified regulation, Integrated regulation, Intrinsic regulation

  13. Fatigue

    Time frame: Baseline

    Parkinson's Fatigue Scale (PFS-16), 16 items scored 1 to 5 from strongly disagree to strongly agree . more points/score= worse.

  14. Disability

    Time frame: Baseline

    World health organization (WHO) disability assessment schedule (Whodas 2.0), 12 self-assessed questions (12 to 60) more points=worse

  15. Self-efficacy

    Time frame: Baseline

    Self-efficacy of exercise/PA (ESES), 10 questions, scored 1-4. higher=better

  16. Sleep

    Time frame: Baseline

    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

    Assessed with visual analog scale, VAS from 0 to 100

  18. Health related quality of life

    Time frame: Baseline

    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, cognitions, 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

    The WHO- Five Well-Being Index (WHO-5), 5 questions ranging from 0 to 5, 0-25, higher=better

  20. Nutrition

    Time frame: Baseline

    Mini Nutritional Assessment, max 14. higher = better

Other outcomes

  1. Working och long-term memory

    Time frame: Baseline

    Rey-Auditory Verbal Learning Test (RAVLT), higher= better

  2. Parkinson related pain

    Time frame: Baseline

    Assessed with the Kings Parkinsons Pain Scale (KPPS), max 168, higher= more pain

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 Skane
  • Region Stockholm
  • Region Västerbotten
  • Umeå University
  • Vastra Gotaland Region

Registry information

Official study title

ActivPARK - Physical Activity in Persons With Parkinson's Disease- Pilot Study

Acronym: ActivPARK

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 30, 2025
Registry last updated
Apr 4, 2025

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.

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