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Clinical Trial NCT06901869 (ActivPARK) for Parkinson Disease, Physical Inactivity is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Physical Activity in Persons With Parkinson's Disease (ActivPARK)

Recruiting
Clinical Trial NCT06901869 (ActivPARK) is an observational study for Parkinson Disease, Physical Inactivity that is recruiting. It started on March 25, 2025 with plans to enroll 50 participants. Led by Karolinska Institutet, it is expected to complete by December 1, 2026. The latest data from ClinicalTrials.gov was last updated on April 4, 2025.
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.

Official Title

ActivPARK - Physical Activity in Persons With Parkinson's Disease- Pilot Study

Conditions
Parkinson DiseasePhysical Inactivity
Other Study IDs
  • ActivPARK
  • 2024-07526-01
  • 2024-06332 (Other Grant/Funding Number) (Swedish Research Council)
NCT ID Number
NCT06901869
Start Date (Actual)
2025-03-25
Last Update Posted
2025-04-04
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
50
Study Type
Observational
Status
Recruiting
Arms / Interventions
Participant Group/ArmIntervention/Treatment
People with Parkinson's disease
No intervention
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 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
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Physical activity - self rated
Frändin Grimby scale, ranging from 1 to 6, higher score=better.
Baseline
Disease severity, Parkinson symptoms
Movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS- UPDRS) parts 1 to 4. Higher scores = worse/more symptoms
Baseline
Gait
Gait speed in m/s measured with the 10 meter walking test or through gait analysis.
Baseline
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. Maximum points 28. 0-28 points with higher scores indicating better balance control
Baseline
Anxiety and depression
Assessed with Hospital Anxiety and Depression Scale (HADS), 0-24 on the depression and anxiety part respectively. Lower score=better
Baseline
Cognitive performance
Assessed with the Montreal Cognitive Assessment (MoCA), 0-25, higher score = better
Baseline and 3 year follow-up
Self assessed cognitive function
Assessed with Executive function questionnaire (DEX), 20 items scored 1 to 4, max 80, more scores= worse.
Baseline
Non-Motor Symptoms
Non-Motor Symptoms Questionnaire (NMSQ), 30 questions with yes/no answer. More yes answers = more non-motor symptoms
Baseline
Walking ability- self assessed
WALK-12G questionnaire, 0 and 42 points, with higher scores reflecting greater perceived walking difficulties (higher=worse)
Baseline
Freezing of gait - self-assessed
Freezing of gait questionnaire (FOGQsa), 6 questions/items, scored 1 to 5 (higher=worse)
Baseline
Balance confidence
Activities specific balance confidence (ABC scale), 16 items which is scored 1 to 10 and then divided by 16. 0-100%, higher % = better
Baseline
Motivation
Behavioural Regulation in Exercise Questionnaire (BREQ 4), 28 items score 1 to 7 and divided into subcomponents: Amotivation, External regulation, Introjected avoidance, Introjected approach, Identified regulation, Integrated regulation, Intrinsic regulation
Baseline
Fatigue
Parkinson's Fatigue Scale (PFS-16), 16 items scored 1 to 5 from strongly disagree to strongly agree . more points/score= worse.
Baseline
Disability
World health organization (WHO) disability assessment schedule (Whodas 2.0), 12 self-assessed questions (12 to 60) more points=worse
Baseline
Self-efficacy
Self-efficacy of exercise/PA (ESES), 10 questions, scored 1-4. higher=better
Baseline
Sleep
Scales for Outcomes in Parkinson's disease - Sleep (SCOPA-SLEEP), 4 parts, A-2 questions, B-5 questions , C-1 question and D- 6 questions. Higher= worse
Baseline
Self rated pain
Assessed with visual analog scale, VAS from 0 to 100
Baseline
Health related quality of life
Parkinson's Disease Questionnaire (PDQ39). The Parkinson's Disease Questionnaire (PDQ-39) assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living (mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communications and bodily discomfort). The sum score is as a percentage score ranging between 0 and 100. Higher is better
Baseline
Wellbeing
The WHO- Five Well-Being Index (WHO-5), 5 questions ranging from 0 to 5, 0-25, higher=better
Baseline
Nutrition
Mini Nutritional Assessment, max 14. higher = better
Baseline
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Eligible Sexes
All
  • Diagnosed with Parkinson's disease
  • Mild to severe disease severity ( Hoehn & Yahr 1-4).

  • None
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Study Responsible Party
Erika Franzén, Principal Investigator, Professor, Karolinska Institutet
Study Central Contact
Contact: Compliance Office Karolinska Insitutet, +46852480000, [email protected]
Contact: Erika Franzén, +46852488878, [email protected]
1 Study Locations in 1 Countries

Solna

Karolinska institutet, Stockholm, Solna, 17177, Sweden
Erika Franzén, PhD, Contact, +46852488878, [email protected]
Erika Franzén, PhD, Principal Investigator
Recruiting