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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-07526-01 | Other Identifier | Swedish Ethical Review Authority | |
| 06901869 | Other Identifier | Clinical Trials registration -pilot study |
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| Name | Class |
|---|---|
| Lund University | OTHER |
| Göteborg University | OTHER |
| UmeĂĄ University | OTHER |
| Region Stockholm |
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This project aims to identify why some people with Parkinson's disease (PwPD) become less physically active, and which factors support or hinder activity. Understanding these factors is essential for developing person centred interventions and effective support that can be implemented in routine healthcare. A national, multicentre longitudinal cohort study will be conducted including approx 450 PwPD from five Swedish regions (including the internal pilot NCT06901869). Physical activity will be measured objectively with activity monitors, combined with clinical assessments and digital questionnaires over four years. The primary outcome is physical activity level (accelerometer measured decline), and exposure variables include physical, cognitive, disease specific, social, environmental, motivational, and personal factors. Data collection involves clinical tests, questionnaires, accelerometer data, and patient reported experiences.
This is a continuation of an internal pilot study NCT06901869. The study will enable early identification of those at risk for declining activity and guide development of person centred, evidence based interventions. Long term, it aims to integrate activity monitoring and risk factor screening into routine care to improve health and quality of life for PwPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| People with Parkinson´'s disease | No intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Physical activity - low and moderate intensity | The primary outcome is changes over time in PA (i.e. low + moderate-vigorous intensity PA in time spent per day) measured with accelerometers (Actigraph GT3X+, Pensacola, FL, US) during 7 days in people with Parkinson's disease everyday life. | Baseline and yearly follow-ups for 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity - total vector magnitude | The secondary outcomes are change over time in total vector magnitude measured with accelerometers (Actigraph GT3X+, Pensacola, FL, US) during 7 days in people with Parkinson's disease everyday life. | Baseline and yearly follow-ups for 3 years |
| Physical activity - low intensity |
| Measure | Description | Time Frame |
|---|---|---|
| Disease severity, Parkinsons symptoms | Disease severity measured with the Movement Disorders Society -Unified Parkinson's Disease Rating Scale) parts 1 to 4. Higher scores = worse/more symptoms | Baseline and 3 year follow-up |
| Gait |
Inclusion Criteria:
Exclusion Criteria:
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People with 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 University Hospital | Recruiting | Stockholm | 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.
We 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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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009043 | Motor Activity |
| 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 |
| Region Norrbotten | OTHER |
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The secondary outcomes are change in time spent in low intensity physical activity per day measured with accelerometers (Actigraph GT3X+, Pensacola, FL, US) during 7 days in people with Parkinson's disease everyday life. |
| Baseline and yearly follow-ups for 3 years |
| Physical activity - moderate high intensity | The secondary outcomes are change in time spent in moderate-vigorous physical activity per day measured with accelerometers (Actigraph GT3X+, Pensacola, FL, US) during 7 days in people with Parkinson's disease everyday life. | Baseline and yearly follow-ups for 3 years |
| Physical activity- sedentary | The secondary outcomes are change in sedentary time per day measured with accelerometers (Actigraph GT3X+, Pensacola, FL, US) during 7 days in people with Parkinson's disease everyday life. | Baseline and yearly follow-ups for 3 years |
| Physical activity - steps | The secondary outcomes are change in steps per day measured with accelerometers (Actigraph GT3X+, Pensacola, FL, US) during 7 days in people with Parkinson's disease everyday life. | Baseline and yearly follow-ups for 3 years |
Gait speed in m/s measured with the 10 meter walking test or through gait analysis.
| Baseline and 3 year follow-up |
| 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. 0-28 points with higher scores indicating better balance control | Baseline and 3 year follow-up |
| Anxiety and depression | Assessed with Hospital Anxiety and Depression Scale (HADS), 0-24 on the depression and anxiety part respectively. Lower score=better | Baseline and yearly follow-ups for 3 years |
| Cognitive performance | Assessed with the Montreal Cognitive Assessment (MoCA), 0-25, higher score = better | Baseline and 3 year follow-up |
| Motivation | Assessed with the Behavioural Regulation in Exercise Questionnaire (BREQ 4), a 28-item survey that measures exercise motivation. The questionnaire uses a 7-point Likert scale, ranging from one to seven. Maximum 196. Higher scores = higher motivation | Baseline and yearly follow-ups for 3 years |
| Self-efficacy | Assessed with the Self-efficacy and motivation for exercise/physical activity (ESES). 10 questions rated on a 4 point Likert scale. Maximun 40 points, higher scores= better self-efficacy | Baseline and yearly follow-ups for 3 years |
| Physical activity history and preferences, | Self-made questions on physical activity history and preferences | Baseline |
| Self assessed cognitive function | Assessed with Executive function questionnaire (DEX), 20 items scored 1 to 4, max 80, more scores= worse | Baseline and yearly follow-ups for 3 years |
| Non-Motor Symptoms | Non-Motor Symptoms Questionnaire (NMSQ), 30 questions with yes/no answer. More yes answers = more non-motor symptoms | Baseline and yearly follow-ups for 3 years |
| Walking ability- self rated | WALK-12G questionnaire, 0 and 42 points, with higher scores reflecting greater perceived walking difficulties (higher=worse) | Baseline and yearly follow-ups for 3 years |
| Freezing of gait - self-assessed | Freezing of gait questionnaire (FOGQsa), 6 questions/items, scored 1 to 5 (higher=worse) | Baseline and 3 year follow-up |
| 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 and yearly follow-ups for 3 years |
| Fatigue | Parkinson's Fatigue Scale (PFS-16), 16 items scored 1 to 5 from strongly disagree to strongly agree . more points/score= worse. | Baseline and yearly follow-ups for 3 years |
| Disability | World health organization (WHO) disability assessment schedule (Whodas 2.0), 12 self-assessed questions (12 to 60) more points=worse | Baseline and 3 year follow-up |
| 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 and 3 year follow-up |
| Self-rated pain | Assessed with visual analog scale, VAS from 0 to 100 | Baseline and yearly follow-ups for 3 years |
| 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, cognition, communications and bodily discomfort). The sum score is as a percentage score ranging between 0 and 100. Higher is better | Baseline and yearly follow-ups for 3 years |
| Wellbeing | The WHO- Five Well-Being Index (WHO-5), 5 questions ranging from 0 to 5, 0-25, higher=better | Baseline and yearly follow-ups for 3 years |
| Nutrition | Mini Nutritional Assessment, max 14. higher = better | Baseline and 3 year follow-up |
| Socioeconomic status | Education and income level. | Baseline |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001519 | Behavior |