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

May 13, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Compliance Office Karolinska Insitutet
  • Phone Number: +46852480000
  • Email: compliance@ki.se

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
People with Parkinson´'s disease
No intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and yearly follow-ups for 3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and yearly follow-ups for 3 years
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.
Baseline and yearly follow-ups for 3 years
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.
Baseline and yearly follow-ups for 3 years
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.
Baseline and yearly follow-ups for 3 years
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.
Baseline and yearly follow-ups for 3 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cognitive performance
Time Frame: Baseline and 3 year follow-up
Assessed with the Montreal Cognitive Assessment (MoCA), 0-25, higher score = better
Baseline and 3 year follow-up
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
Baseline and 3 year follow-up
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.
Baseline and 3 year follow-up
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
Baseline and 3 year follow-up
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
Baseline and yearly follow-ups for 3 years
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
Baseline and yearly follow-ups for 3 years
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
Baseline and yearly follow-ups for 3 years
Physical activity history and preferences,
Time Frame: Baseline
Self-made questions on physical activity history and preferences
Baseline
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
Baseline and yearly follow-ups for 3 years
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
Baseline and yearly follow-ups for 3 years
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)
Baseline and yearly follow-ups for 3 years
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)
Baseline and 3 year follow-up
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
Baseline and yearly follow-ups for 3 years
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.
Baseline and yearly follow-ups for 3 years
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
Baseline and 3 year follow-up
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
Baseline and 3 year follow-up
Self-rated pain
Time Frame: 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
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
Baseline and yearly follow-ups for 3 years
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
Baseline and yearly follow-ups for 3 years
Nutrition
Time Frame: Baseline and 3 year follow-up
Mini Nutritional Assessment, max 14. higher = better
Baseline and 3 year follow-up
Socioeconomic status
Time Frame: Baseline
Education and income level.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lund University
Göteborg University
Umeå University
Vastra Gotaland Region
Region Skane
Region Stockholm
Region Västerbotten
Region Norrbotten

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Erika Franzén, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4-438/2024
  • 2024-07526-01 (Other Identifier: Swedish Ethical Review Authority)
  • 06901869 (Other Identifier: Clinical Trials registration -pilot study)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

We plan to share this when applicable on OSF or similar

IPD Sharing Access Criteria

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 Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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