Clinical trial NCT06901869: Physical Activity in Persons With Parkinson's Disease
Official title: ActivPARK - Physical Activity in Persons With Parkinson's Disease- Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Physical Inactivity
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Lund University
name: Göteborg University
name: Umeå University
name: Region Stockholm
name: Vastra Gotaland Region
name: Region Skane
name: Region Västerbotten
First posted: 2025-03-30
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson's disease with mild to severe severity (Hoehn \& Yahr 1-4) of all ages

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Parkinson's disease
* Mild to severe disease severity ( Hoehn \& Yahr 1-4).

Exclusion Criteria:

* None

Primary outcomes:
measure: Feasibility of the assessment battery - length of the clinical examination and questionnaires
timeFrame: Baseline
measure: Feasibility of the assessment battery - perception of the clinical examination
timeFrame: Baseline
measure: Feasibility of the assessment battery -Compliance to questionnaires sent via REDCap
timeFrame: Baselline
measure: Feasibility of the assessment battery - Suitability of the primary outcome
timeFrame: Baseline
measure: Physical activity levels
timeFrame: Baseline
Secondary outcomes:
measure: Physical activity - self rated
timeFrame: Baseline
measure: Disease severity, Parkinson symptoms
timeFrame: Baseline
measure: Gait
timeFrame: Baseline
measure: Balance performance
timeFrame: Baseline
measure: Anxiety and depression
timeFrame: Baseline
measure: Cognitive performance
timeFrame: Baseline and 3 year follow-up
measure: Self assessed cognitive function
timeFrame: Baseline
measure: Non-Motor Symptoms
timeFrame: Baseline
measure: Walking ability- self assessed
timeFrame: Baseline
measure: Freezing of gait - self-assessed
timeFrame: Baseline
measure: Balance confidence
timeFrame: Baseline
measure: Motivation
timeFrame: Baseline
measure: Fatigue
timeFrame: Baseline
measure: Disability
timeFrame: Baseline
measure: Self-efficacy
timeFrame: Baseline
measure: Sleep
timeFrame: Baseline
measure: Self rated pain
timeFrame: Baseline
measure: Health related quality of life
timeFrame: Baseline
measure: Wellbeing
timeFrame: Baseline
measure: Nutrition
timeFrame: Baseline
Other outcomes:
measure: Working och long-term memory
timeFrame: Baseline
measure: Parkinson related pain
timeFrame: Baseline
Locations:
city: Stockholm
country: Sweden
facility: Karolinska institutet
state: Solna
Study officials:
affiliation: Karolinska Institutet
name: Erika Franzén
role: PRINCIPAL_INVESTIGATOR
References: