Karolinska institutet
Stockholm, Solna, 17177, Sweden
Location status: Recruiting
NCT Number: NCT06901869
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.
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Observational
Stockholm, Solna, 17177, Sweden
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
The pilot/feasibility study aims to evaluate feasibility of the assessment battery measured the time it takes to complete the examination and questionnaires.
Time frame: 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.
Time frame: Baselline
Compliance will be measured with percentages of completed questionnaires in REDCap.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Frändin Grimby scale, ranging from 1 to 6, higher score=better.
Time frame: Baseline
Movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS- UPDRS) parts 1 to 4.
Higher scores = worse/more symptoms
Time frame: Baseline
Gait speed in m/s measured with the 10 meter walking test or through gait analysis.
Time frame: 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
Time frame: Baseline
Assessed with Hospital Anxiety and Depression Scale (HADS), 0-24 on the depression and anxiety part respectively. Lower score=better
Time frame: Baseline and 3 year follow-up
Assessed with the Montreal Cognitive Assessment (MoCA), 0-25, higher score = better
Time frame: Baseline
Assessed with Executive function questionnaire (DEX), 20 items scored 1 to 4, max 80, more scores= worse.
Time frame: Baseline
Non-Motor Symptoms Questionnaire (NMSQ), 30 questions with yes/no answer. More yes answers = more non-motor symptoms
Time frame: Baseline
WALK-12G questionnaire, 0 and 42 points, with higher scores reflecting greater perceived walking difficulties (higher=worse)
Time frame: Baseline
Freezing of gait questionnaire (FOGQsa), 6 questions/items, scored 1 to 5 (higher=worse)
Time frame: Baseline
Activities specific balance confidence (ABC scale), 16 items which is scored 1 to 10 and then divided by 16. 0-100%, higher % = better
Time frame: 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
Time frame: Baseline
Parkinson's Fatigue Scale (PFS-16), 16 items scored 1 to 5 from strongly disagree to strongly agree . more points/score= worse.
Time frame: Baseline
World health organization (WHO) disability assessment schedule (Whodas 2.0), 12 self-assessed questions (12 to 60) more points=worse
Time frame: Baseline
Self-efficacy of exercise/PA (ESES), 10 questions, scored 1-4. higher=better
Time frame: 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
Time frame: Baseline
Assessed with visual analog scale, VAS from 0 to 100
Time frame: 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
Time frame: Baseline
The WHO- Five Well-Being Index (WHO-5), 5 questions ranging from 0 to 5, 0-25, higher=better
Time frame: Baseline
Mini Nutritional Assessment, max 14. higher = better
Time frame: Baseline
Rey-Auditory Verbal Learning Test (RAVLT), higher= better
Time frame: Baseline
Assessed with the Kings Parkinsons Pain Scale (KPPS), max 168, higher= more pain
Contact information is provided by the study sponsor or research team.
Compliance Office Karolinska Insitutet
CONTACT
Erika Franzén
CONTACT
Karolinska Institutet
Other
ActivPARK - Physical Activity in Persons With Parkinson's Disease- Pilot Study
Acronym: ActivPARK
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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