Physical Activity in Persons With Parkinson's Disease

NCT07585409 | Recruiting

• 3 other identifiers: 4-438/20242024-07526-0106901869
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

PARKINSON DISEASE (Disorder); Physical Activity; Sedentary Behaviors

Keywords

Parkinson's disease; Physical activity; activity monitors; accelerometers

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and yearly follow-ups for 3 years

Secondary Outcomes (5)

• Physical activity - total vector magnitude

  Baseline and yearly follow-ups for 3 years

• Physical activity - low intensity

  Baseline and yearly follow-ups for 3 years

• Physical activity - moderate high intensity

  Baseline and yearly follow-ups for 3 years

• Physical activity- sedentary

  Baseline and yearly follow-ups for 3 years

• Physical activity - steps

  Baseline and yearly follow-ups for 3 years

Other Outcomes (21)

• Disease severity, Parkinsons symptoms

  Baseline and 3 year follow-up

• Gait

  Baseline and 3 year follow-up

• Balance performance

  Baseline and 3 year follow-up

Study Arms (1)

People with Parkinson´'s disease

No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• People diagnosed with idiopathic Parkinson's disease
• Hoehn \& Yahr 1 to 4

You may not qualify if:

• Hoehn \& Yahr 5 (i.e. wheelchair bound or bedridden unless aided)
• Unable to perform critical physical activity and clinical assessments

Sponsors & Collaborators

• Karolinska Institutet: lead
• Lund University: collaborator
• Göteborg University: collaborator
• Umeå University: collaborator
• Region Stockholm: collaborator
• Vastra Gotaland Region: collaborator
• Region Skane: collaborator
• Region Västerbotten: collaborator
• Region Norrbotten: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Study Officials

• Erika Franzén

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Compliance Office Karolinska Insitutet

CONTACT

+46852480000; compliance@ki.se

Erika Franzén

CONTACT

+46852488878; erika.franzen@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 13, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): January 30, 2031
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: We plan to share this when applicable on OSF or similar
• 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.

Locations

SE (1)