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Recruiting NCT07585409

Physical Activity in Persons With Parkinson's Disease

Observational PARKINSON DISEASE (Disorder) Physical Activity Sedentary Behaviors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: PARKINSON DISEASE (Disorder), Physical Activity, Sedentary Behaviors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Physical Activity in Persons With Parkinson's Disease - a Longitudinal Cohort Study

Overview

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.

Primary outcome measures

  • Physical activity - low and moderate intensity [Time frame: Baseline and yearly follow-ups for 3 years]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Karolinska University Hospital — Stockholm

Identifiers

NCT: NCT07585409 · 4-438/2024 · 2024-07526-01 · 06901869

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗