NCT06901869|Recruiting
Physical Activity in Persons With Parkinson's Disease
ActivPARK
ActivPARK - Physical Activity in Persons With Parkinson's Disease- Pilot Study
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ActivPARK
ActivPARK - Physical Activity in Persons With Parkinson's Disease- Pilot Study
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Swedish Research Council
observational
50
1 country
1
Study Start
March 25, 2025
Actual (reported)Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Parkinson's disease (PD) is a leading neurodegenerative health condition in Sweden and a public health concern. Although no cure exists, functional independence and participation in society remain top priorities, and can be achieved through targeted physical activity (PA) interventions. To date, few longitudinal cohort studies have been conducted, using PA as main outcome in therapy research, partly due to the complex nature of predicting and controlling this phenomenon. To help address this knowledge gap, the overall purpose of the future long-term (ActivPARK) study is to enhance knowledge of the evolution of PA behavior, and how it is influenced beyond the disease characteristics using a broad explanatory model, in persons with PD from a diversity of settings in Sweden with the aim of prescribing tailored and personalized interventions to enhance functioning, health, and wellbeing throughout the disease progression and recommend potential health care pathway modifications. The investigators have just established an expert group, comprising researchers, healthcare professionals, and PD organisations (including persons with PD) and reached consensus on essential priority clinical therapy research questions on PA and methodological considerations. The next phase entails performing a multicentre feasibility/pilot study, further developing and refining the assessment battery and research questions linked to the improved explanatory model for PA and methodology, to inform the definite larger clinical cohort study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 17, 2025
Actual (reported)March 25, 2025
Actual (reported)March 30, 2025
Actual (reported)December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Feasibility of the assessment battery - length of the clinical examination and questionnaires
The pilot/feasibility study aims to evaluate feasibility of the assessment battery measured the time it takes to complete the examination and questionnaires.
Baseline
Feasibility of the assessment battery - perception of the clinical examination
Feasibility of the assessment battery will also be evaluated through semi-structured questions regarding fatique, concentration, pain/discomfort to the participants after the clinical examination.
Baseline
Feasibility of the assessment battery -Compliance to questionnaires sent via REDCap
Compliance will be measured with percentages of completed questionnaires in REDCap.
Baselline
Feasibility of the assessment battery - Suitability of the primary outcome
Suitability of the accelerometers in the home environment as the primary outcome for the targeted patient group will be assessed by the percentage of participants that are able to wear the accelerometer for at least 4 days days and render valid data.
Baseline
Physical activity - self rated
Baseline
Disease severity, Parkinson symptoms
Baseline
Gait
Baseline
Balance performance
Baseline
Anxiety and depression
Baseline
Working och long-term memory
Baseline
Parkinson related pain
Baseline
No intervention
Parkinson's disease with mild to severe severity (Hoehn \& Yahr 1-4) of all ages
Karolinska institutet
Stockholm, Solna, 17177, Sweden
Erika Franzén
Karolinska Institutet
First Submitted
March 17, 2025
First Posted
March 30, 2025
Study Start
March 25, 2025
Actual (reported)Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Physical activity levels
The ActiGraph accelerometer (GT3X+, ActiGraph, Pensacola, FL, US) will be used to measure absolute and relative time spent in sedentary behavior, low intensity physical activity (LIPA) and moderate to vigorous intensity physical activity (MVPA), by total time in bouts.
Baseline
Contact the study team to confirm eligibility.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 4, 2025
Record last verified: 2025-04
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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Source: ClinicalTrials.gov.
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