Physical Activity in Persons With Parkinson's Disease

Recruiting

• Conditions: Parkinson Disease; Physical Inactivity

• Registration Number: NCT06901869
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-03-23
• Study Start: 2025-03-25
• Study First Posted: 2025-03-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of the assessment battery - length of the clinical examination and questionnaires	Baseline	The pilot/feasibility study aims to evaluate feasibility of the assessment battery measured the time it takes to complete the examination and questionnaires.
Feasibility of the assessment battery - perception of the clinical examination	Baseline	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.
Feasibility of the assessment battery -Compliance to questionnaires sent via REDCap	Baselline	Compliance will be measured with percentages of completed questionnaires in REDCap.
Feasibility of the assessment battery - Suitability of the primary outcome	Baseline	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.
Physical activity levels	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
Balance performance	Baseline	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
Anxiety and depression	Baseline	Assessed with Hospital Anxiety and Depression Scale (HADS), 0-24 on the depression and anxiety part respectively. Lower score=better
Cognitive performance	Baseline and 3 year follow-up	Assessed with the Montreal Cognitive Assessment (MoCA), 0-25, higher score = better
Self assessed cognitive function	Baseline	Assessed with Executive function questionnaire (DEX), 20 items scored 1 to 4, max 80, more scores= worse.
Non-Motor Symptoms	Baseline	Non-Motor Symptoms Questionnaire (NMSQ), 30 questions with yes/no answer. More yes answers = more non-motor symptoms
Walking ability- self assessed	Baseline	WALK-12G questionnaire, 0 and 42 points, with higher scores reflecting greater perceived walking difficulties (higher=worse)
Freezing of gait - self-assessed	Baseline	Freezing of gait questionnaire (FOGQsa), 6 questions/items, scored 1 to 5 (higher=worse)
Balance confidence	Baseline	Activities specific balance confidence (ABC scale), 16 items which is scored 1 to 10 and then divided by 16. 0-100%, higher % = better
Motivation	Baseline	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
Fatigue	Baseline	Parkinson's Fatigue Scale (PFS-16), 16 items scored 1 to 5 from strongly disagree to strongly agree . more points/score= worse.
Disability	Baseline	World health organization (WHO) disability assessment schedule (Whodas 2.0), 12 self-assessed questions (12 to 60) more points=worse
Self-efficacy	Baseline	Self-efficacy of exercise/PA (ESES), 10 questions, scored 1-4. higher=better
Sleep	Baseline	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
Self rated pain	Baseline	Assessed with visual analog scale, VAS from 0 to 100
Health related quality of life	Baseline	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
Wellbeing	Baseline	The WHO- Five Well-Being Index (WHO-5), 5 questions ranging from 0 to 5, 0-25, higher=better
Nutrition	Baseline	Mini Nutritional Assessment, max 14. higher = better
Physical activity - self rated	Baseline	Frändin Grimby scale, ranging from 1 to 6, higher score=better.
Disease severity, Parkinson symptoms	Baseline	Movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS- UPDRS) parts 1 to 4.; Higher scores = worse/more symptoms
Gait	Baseline	Gait speed in m/s measured with the 10 meter walking test or through gait analysis.

Trial Locations

Locations (1)

Karolinska institutet; 🇸🇪 Stockholm, Solna, Sweden