PARKINSON DISEASE (Disorder)ActivPARKNCT07585409
Physical Activity in Persons With Parkinson's Disease
An observational study of PARKINSON DISEASE (Disorder) and Physical Activity, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PARKINSON DISEASE (Disorder), Physical Activity, Sedentary Behaviors
- How many people
- 450 participants
- Where
- 1 siteSweden
- Study dates
- 15 Jan 2026to 30 Jan 2031
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with Parkinson's disease with mild to severe severity (Hoehn \& Yahr 1-4) of all ages
Who may be able to join
- People diagnosed with idiopathic Parkinson's disease
- Hoehn \& Yahr 1 to 4
Who cannot join
- Hoehn \& Yahr 5 (i.e. wheelchair bound or bedridden unless aided)
- Unable to perform critical physical activity and clinical assessments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm
Erika Franzén, PhD, +46852488878, erika.franzen@ki.se
LIsa Sandberg, MSc, lisa.sandberg@ki.se
About this study
Official title: 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.
- Keywords
- Parkinson's disease, Physical activity, activity monitors, accelerometers
- Medical subject headings
- Parkinson Disease, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| People with Parkinson´'s disease | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity - low and moderate intensity
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.
Measured: Baseline and yearly follow-ups for 3 years
Secondary outcomes (5)
Physical activity - total vector magnitude
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.
Measured: Baseline and yearly follow-ups for 3 years
Physical activity - low intensity
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.
Measured: Baseline and yearly follow-ups for 3 years
Physical activity - moderate high intensity
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.
Measured: Baseline and yearly follow-ups for 3 years
Physical activity- sedentary
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.
Measured: Baseline and yearly follow-ups for 3 years
Physical activity - steps
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.
Measured: Baseline and yearly follow-ups for 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start15 Jan 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion30 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, Göteborg University, Umeå University, Region Stockholm, Vastra Gotaland Region, Region Skane, Region Västerbotten, Region Norrbotten
- Responsible party
- Principal investigator, Erika Franzén, Karolinska Institutet
- Investigators
- Erika Franzén, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585409
- Sponsor's protocol ID
- 4-438/2024
- Other IDs
- 2024-07526-01, 06901869
- Acronym
- ActivPARK
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 15 May 2026
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity in Persons With Parkinson's Disease - a Longitudinal Cohort Study
- ClinicalTrials.gov ID
- NCT07585409
- Acronym / sponsor ID
- ActivPARK / 4-438/2024
- Keywords
- Parkinson's disease, Physical activity, activity monitors, accelerometers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Lund University, Göteborg University, Umeå University, Region Stockholm, Vastra Gotaland Region, Region Skane, Region Västerbotten, Region Norrbotten
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 30 Jan 2031 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with Parkinson´'s disease | – | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with Parkinson's disease with mild to severe severity (Hoehn \& Yahr 1-4) of all ages
Key inclusion criteria (2 listed)
- People diagnosed with idiopathic Parkinson's disease
- Hoehn \& Yahr 1 to 4
Key exclusion criteria (2 listed)
- Hoehn \& Yahr 5 (i.e. wheelchair bound or bedridden unless aided)
- Unable to perform critical physical activity and clinical assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Physical activity - total vector magnitude
Time frame: Baseline and yearly follow-ups for 3 years
Physical activity - low intensity
Time frame: Baseline and yearly follow-ups for 3 years
Physical activity - moderate high intensity
Time frame: Baseline and yearly follow-ups for 3 years
Physical activity- sedentary
Time frame: Baseline and yearly follow-ups for 3 years
Physical activity - steps
Time frame: Baseline and yearly follow-ups for 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erika Franzén principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PARKINSON DISEASE (Disorder) and Physical Activity, 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 2 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 15 May 2026. 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?
Physical activity - low and moderate intensity (time frame: Baseline and yearly follow-ups for 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2026.