Physical Activity in Persons With Parkinson's Disease (ActivPARK)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease; Physical Inactivity

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Compliance Office Karolinska Insitutet; Phone Number: +46852480000; Email: compliance@ki.se
• Study Contact Backup: Name: Erika Franzén; Phone Number: +46852488878; Email: erika.franzen@ki.se

Study Locations

• Sweden
  • Solna
    • Stockholm, Solna, Sweden, 17177
      • Recruiting
      • Karolinska Institutet
      • Contact: Erika Franzén, PhD; Phone Number: +46852488878; Email: erika.franzen@ki.se
      • Principal Investigator: Erika Franzén, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Parkinson's disease with mild to severe severity (Hoehn & Yahr 1-4) of all ages

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
People with Parkinson's disease; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Working och long-term memory	Rey-Auditory Verbal Learning Test (RAVLT), higher= better	Baseline
Parkinson related pain	Assessed with the Kings Parkinsons Pain Scale (KPPS), max 168, higher= more pain	Baseline

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Lund University; Göteborg University; Umeå University; Vastra Gotaland Region; Region Skane; Region Stockholm; Region Västerbotten
• Investigators: Principal Investigator: Erika Franzén, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: March 23, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: 2024-07526-01 (Other Identifier: Swedish Ethical Review Authority); 2024-06332 (Other Grant/Funding Number: Swedish Research Council)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The investigators plan to share this when applicable on OSF or similar
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No