Physical Activity in Persons With Parkinson's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarolinska Institutet
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
People diagnosed with idiopathic Parkinson's disease
Hoehn & Yahr 1 to 4
Disqualifiers
Hoehn & Yahr 5 (i.e. wheelchair bound or bedridden unless aided)
Unable to perform critical physical activity and clinical assessments
Trial population
People with Parkinson's disease with mild to severe severity (Hoehn \& Yahr 1-4) of all ages
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
450 Participants
are grouped into 1 trial groupGroup A: People with Parkinson´'s disease
Trial outcomes
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.
Time frame
Baseline and yearly follow-ups for 3 yearsSecondary outcomes
1
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.
Time frame
Baseline and yearly follow-ups for 3 years2
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.
Time frame
Baseline and yearly follow-ups for 3 years3
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.
Time frame
Baseline and yearly follow-ups for 3 years4
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.
Time frame
Baseline and yearly follow-ups for 3 yearsOther outcomes
1
Disease severity, Parkinsons symptoms
Disease severity measured with the Movement Disorders Society -Unified Parkinson's Disease Rating Scale) parts 1 to 4. Higher scores = worse/more symptoms
Time frame
Baseline and 3 year follow-up2
Gait
Gait speed in m/s measured with the 10 meter walking test or through gait analysis.
Time frame
Baseline and 3 year follow-up3
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. 0-28 points with higher scores indicating better balance control
Time frame
Baseline and 3 year follow-up4
Anxiety and depression
Assessed with Hospital Anxiety and Depression Scale (HADS), 0-24 on the depression and anxiety part respectively. Lower score=better
Time frame
Baseline and yearly follow-ups for 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
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
Source ClinicalTrials.gov