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Parkinson DiseaseActivPARKNCT06901869

Physical Activity in Persons With Parkinson's Disease

An observational study of Parkinson Disease and Physical Inactivity, run by Karolinska Institutet at 1 site in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Parkinson Disease, Physical Inactivity
How many people
50 participants
Where
1 siteSweden
Study dates
25 Mar 2025to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Parkinson's disease with mild to severe severity (Hoehn \& Yahr 1-4) of all ages

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Compliance Office Karolinska Insitutet contact

+46852480000

compliance@ki.se

Erika Franzén contact

+46852488878

erika.franzen@ki.se

Sweden1 site, 1 recruiting

  • Karolinska institutet

    Stockholm, Solna, 17177

    Erika Franzén, PhD, +46852488878, erika.franzen@ki.se

    Erika Franzén, PhD

    Recruiting

Other trials in Sweden

About this study

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

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.

Medical subject headings
Parkinson Disease, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06901869
Study groupRoleWhat they receive
People with Parkinson's diseaseNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Baseline

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

    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.

    Measured: Baseline

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

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

    Measured: Baselline

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

    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.

    Measured: Baseline

  5. Physical activity levels

    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.

    Measured: Baseline

Secondary outcomes (20)

  1. Physical activity - self rated

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

    Measured: Baseline

  2. Disease severity, Parkinson symptoms

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

    Higher scores = worse/more symptoms

    Measured: Baseline

  3. Gait

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

    Measured: Baseline

  4. Balance performance

    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

    Measured: Baseline

  5. Anxiety and depression

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

    Measured: Baseline

  6. Cognitive performance

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

    Measured: Baseline and 3 year follow-up

  7. Self assessed cognitive function

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

    Measured: Baseline

  8. Non-Motor Symptoms

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

    Measured: Baseline

  9. Walking ability- self assessed

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

    Measured: Baseline

  10. Freezing of gait - self-assessed

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

    Measured: Baseline

  11. Balance confidence

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

    Measured: Baseline

  12. Motivation

    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

    Measured: Baseline

  13. Fatigue

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

    Measured: Baseline

  14. Disability

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

    Measured: Baseline

  15. Self-efficacy

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

    Measured: Baseline

  16. Sleep

    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

    Measured: Baseline

  17. Self rated pain

    Assessed with visual analog scale, VAS from 0 to 100

    Measured: Baseline

  18. Health related quality of life

    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

    Measured: Baseline

  19. Wellbeing

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

    Measured: Baseline

  20. Nutrition

    Mini Nutritional Assessment, max 14. higher = better

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2025
  2. Study start25 Mar 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06901869
Sponsor's protocol ID
2024-07526-01
Other IDs
2024-06332
Acronym
ActivPARK
Status last verified
Apr 2025
First submitted
17 Mar 2025
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease and Physical Inactivity, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Compliance Office Karolinska Insitutet (+46852480000, compliance@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the assessment battery - length of the clinical examination and questionnaires (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06901869.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

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