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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-06332 | Other Grant/Funding Number | Swedish Research Council |
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| Name | Class |
|---|---|
| Lund University | OTHER |
| Göteborg University | OTHER |
| Umeå University | OTHER |
| Region Stockholm |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People with Parkinson's disease | No intervention |
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| Measure | Description | Time 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Parkinson's disease with mild to severe severity (Hoehn & Yahr 1-4) of all ages
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Compliance Office Karolinska Insitutet | Contact | +46852480000 | compliance@ki.se | |
| Erika Franzén | Contact | +46852488878 | erika.franzen@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Erika Franzén | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska institutet | Recruiting | Stockholm | Solna | 17177 | Sweden |
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.
The investigators plan to share this when applicable on OSF or similar
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 5, 2025 | Mar 6, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| OTHER_GOV |
| Vastra Gotaland Region | OTHER_GOV |
| Region Skane | OTHER |
| Region Västerbotten | OTHER_GOV |
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| 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 |
| Baseline |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001519 | Behavior |