ActivPARK - Physical Activity in Persons With Parkinson's Disease- Pilot Study
Conditions: Parkinson Disease, Physical Inactivity
Sponsor: Karolinska Institutet

 
 
 
2025 
ActivPARK – Physical activity in persons with 
Parkinson’s disease 
DOCUMENT APPROVED BY THE ETHICS AUTHORITY IN 
SWEDEN 2025-02-05, DNR 2024-07526-01 
     

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ActivPARK – Physical activity in persons with Parkinson’s disease  
 
Introduction and aims 
The long-term goal of this multicenter clinical cohort study (ActivPARK) is to maintain and 
enhance functioning, health, and wellbeing in persons with Parkinson’s disease (PwPD) by 
tailored and personalized physical activity (PA) interventions. A prerequisite for designing a 
potent intervention is that we understand how PA is perceived and influenced. There is a 
critical need to develop a comprehensive understanding of predictive factors of PA in PwPD.  
To achieve this goal, we need to enhance knowledge of the evolution of PA behavior with the 
diversity of patient profiles (characteristics, clinical and functioning outcomes) in different 
regions of Sweden. This will be achieved by establishing a longitudinal and multicenter 
cohort study. 
The research idea for the multicenter cohort study is founded on the knowledge that 
remaining and engaging in health-enhancing activities while living with PD is crucial for 
maintaining and improving functioning, health, and wellbeing. The longitudinal nature of the 
study will further enable the identification of different target groups and phenotypes, as well 
as deriving interventions / targets to facilitate more contextually relevant care pathways and 
treatments.     
The development and preparation phase are ongoing (see figure below for a methodological 
overview of all phases). We hereby apply for ethical approval for the pilot phase, to conduct 
a multi-center feasibility cohort study in Sweden, i.e., to inform and refine processes and 
scientific criteria for the definitive national longitudinal cohort study and for the national 
study phase, performing the full-scale clinical cohort study with a qualitative sub study 
using semi-structured interviews.  
 
 
 
Specific aims 
Pilot phase 
▪ 
To explore process feasibility (i.e., determining recruitment rates, retention rates, 
representative sample, eligibility criteria, viability of assessment battery in multiple 
modes, coordination between multiple sites) and scientific feasibility (i.e., safety and 
sample diversity and representativity). 
 
Figure 1. Phases and process of the project. Here we apply for the Pilot phase and the National study phase. 

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National cohort phase 
▪ 
To describe physical activity levels and sedentary behavior in people with Parkinsons 
disease. 
▪ To identify risk factors of physical inactivity and sedentary behavior in PwPD.  
▪ To explore changes and identify predictors of changes in PA and sedentary behavior in 
PwPD across Sweden.  
▪ To describe and explore experiences of physical activity and every day activities as well 
as perceptions of facilitators and barriers for being physically active with PD (qualitative 
sub study). 
Research questions 
- 
How feasible is the ActivPARK study regarding assessments and study 
procedure/design, as well as sample diversity and representativity. 
- 
How physically active are PwPD in different stages of the disease, or with different 
phenotypes.  
- 
What factors are associated with physical activity level (including different intensity 
levels), inactivity, and sedentary behavior (cross-sectional and longitudinal) in people 
with Parkinson’s disease? 
- 
What factors influence inactivity and sedentary behavior in people with Parkinson's 
disease?  
- 
How does the level of physical activity and sedentary behavior change over time in 
PwPD? Does this differ in relation to different PD-subtypes? 
- 
What factors can predict that people with Parkinson's disease will become inactive 
and more sedentary? 
- 
How do people with Parkinson's disease describe and experience physical activity in 
daily life? 
- 
What do people with Parkinson's perceive as facilitators and barriers for being 
physically active? 
Background 
Parkinson’s disease (PD) is globally one of the leading neurodegenerative health 
conditions, where a doubled prevalence is projected [1]. PD is a neurodegenerative disease 
characterized by both motor (slowness of movement, tremor, rigidity, and impaired balance) 
and non-motor symptoms (cognition, sleep, depression, and anxiety), that influence 
engagement in PA. The benefits of exercise and PA for PwPD are strongly supported in the 
literature [2]. PwPD have much to gain from engaging in a physically active lifestyle in terms 
of managing and potentially modifying symptom progression [3]. Despite the proven benefits 
of PA, PwPD are generally less physically active than healthy people of similar age [4]. 
Physical inactivity is seen early in the disease course and likely declines prior to clinically 
visible motor symptoms [5]. Early detection of reduced PA might be critical for preventing 
physical decline and secondary diseases/symptoms such as cardiovascular disease, falls or 
pain in PwPD [6].  
Another critical reason why we still lack a good understanding of PD and effective treatment 
lies in the heterogeneity and complexity of the disease. Even though the evidence of 
individual clinical heterogeneity increases, different subtypes of PD remain insufficiently 
investigated in relation to PA. Our group recently provided novel insights into three distinct 
PA profiles (Sedentary, Light Movers, and Steady Movers) in PwPD [7, 8], se figure 2. 
“Sedentary” included PwPD with greater time spent in sedentary behavior, little time in light 
intensity physical activity (LIPA), and negligible time in moderate-to-vigorous physical activity 
(MVPA). “Light Movers” were PwPD with values close to the mean for all activity variables. 
“Steady Movers” spent less time in sedentary behavior during midday, and more time in LIPA 
and MVPA throughout the day, compared to the other profiles. “Sedentary” people were 
characterized by poorer balance and functional mobility and were more likely to have fallen 

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previously. However, the robustness of these subtypes over time with disease progression is 
unknown. We also lack knowledge of predictive factors for developing a sedentary lifestyle.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PA and exercise interventions have been found to be effective as symptomatic treatment and 
potentially slowing the progression of the disease [6, 9, 10]. Despite this, high-quality clinical 
PD-cohort databases that includes PA is lacking, and PA-data is unavailable in any existing 
health registry in Sweden (including the National PD Patient Registry, PARKreg).  
 
Activity sensors (accelerometers) have revolutionized the measurement of PA in everyday 
life and proved valid in PwPD [11, 12]. However, international health registers still rely on 
self-reported PA data [13], which has limited validity due to re-call bias and conceptual or 
cultural differences in PA related definitions. In relation to prediction of PA behavior, most 
prior studies used limited explanatory models, often restricted to disease-characteristics and 
clinically derived physical functioning data. Few efforts have been made to explore multi-
domain measurements longitudinally including contextual factors [14, 15] (e.g., personal 
factors such as preferences, habits, motivation, and environmental factors) to better 
understand how PA should be targeted to enhance health and wellbeing in PwPD. 
Furthermore, knowledge of the interplay between health care utilization (including 
pharmacological and non-pharmacological interventions) and PA status among PwPD is 
limited. This “black box” concerning conceptual understanding of PA in PwPD hinders the 
development of tailored and person-centered interventions to be the primary impetus for 
enhancing functioning. It is therefore necessary to deepen the contextual knowledge and fill 
this knowledge gap about PA using a multicenter clinical cohort study. This, to examine 
the burden, determine influential factors on PA, categorize the modifiability of factors, and 
determine intervention targets for future clinical trials and implementation. 
 
Preliminary and previous results 
During the last 10 years, our group has extensively explored PA and exercise in PwPD, 
including using neuroimaging methods to relate behavioral changes to brain structure and 
function. We have described PA levels and patterns as well as identified different subtypes of 
PA patterns in PwPD [4, 8]. Further, we have proposed and validated cut-offs for different 
Figure 2. Illustration of PA-subtypes in PwPD. 

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levels of PA and investigated immediate and long-term responses to exercise interventions 
in rigorous clinical trials [11, 16-18]. Recently, we described and compared PA and health in 
PwPD during the pandemic [19]. This brought us insights into the need to contribute to the 
literature gap on longitudinal studies measuring objective PA patterns and influential factors 
in PwPD. 
 
During 2024, we have worked with planning and developing the ActivPARK project in a 
development phase (see figure 1) with consensus iterations for final recommendations. A 
national, multistakeholder expert / steering group was formed. The group identified key initial 
recommendations on “what” should be evaluated in reference to PA, “how” it should be 
measured, as well as “where” and “when”. This was done by using the nominal group 
techniques as underlying methodology. The nominal group technique utilizes both qualitative 
and quantitative methodologies, and its highly structured discussions helps to generate 
views and experiences from a wide range of participants [20]. The feasibility of the key 
decisions will subsequently be tested in the pilot phase.  
 
Methods  
Study design 
The ActivPARK study is a large multicenter study with open cohort design with several sites 
across Sweden (e.g., Lund/Malmö, Umeå, Göteborg, Stockholm). This project is designed in 
a resource effective way with follow-ups on distance and by using digital 
questionnaires/assessments. We will initiate with a pilot study investigating feasibility 
components for the larger multicenter study evaluating such as recruitment rates, the 
diversity of the population, outcome measures and coordination of sites. The larger cohort 
study will also include a cross-sectional qualitative sub study using individual semi-structured 
interviews to gain deeper understanding of the barriers and facilitators to physical activity in 
PwPD. 
 
Participants and recruitment 
PwPD will be recruited through advertisement, other research studies, patient organizations 
and our established collaboration with clinical sites (hospitals, rehabilitation clinics and 
primary care facilities). We will include participants diagnosed with PD with mild to severe 
severity (Hoehn & Yahr 1-4). However, we will screen for people with speech or cognitive 
difficulties that affect the ability to understand and follow verbal/written instructions to 
highlight this specific subset which would otherwise require more intense health and social 
care services. We anticipate that they will be a small part of the cohort and will adapt the 
core set to be able to include them as well. 
 
Testing procedure  
• 
Baseline measurements will consist of a clinical visit and questionnaires sent out via 
REDCap. 
• 
Follow-up measurements will be performed in years 1 and 2 through telephone 
interviews, questionnaires via REDCap and an accelerometer will be sent to each 
participant and returned using pre-stamped envelopes.  
• 
In year 3, the participants will be invited for a clinical visit, be asked to wear an 
accelerometer for a week as well as questionnaires via REDCap.  
 
Main outcome  
PA as a multidimensional behavior can inform about health and well-being of PwPD. The 
ActiGraph accelerometer (GT3X+, ActiGraph, Pensacola, FL, US) will be used to measure 
absolute and relative time spent in sedentary behavior, LIPA, and MVPA, by total time in 
bouts or through variation over a day. We will assess PA with accelerometers both at the 
baseline visit and all of the follow-up assessments. The participants will be instructed to wear 

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the accelerometer on the hip for seven consecutive days, which provides ecologically valid 
measured PA. Our research group has previously developed disease-sensitive cut-off points 
for intensity classification of PA in PwPD [11] as well as a used a similar a protocol for 
remote assessment in the home environment [19].   
 
 
 
 
 
 
Explanatory variables 
The findings from the national steering group’s initial recommendations on explanatory 
models / factors to consider for PA will be included. Apart from disease-related variables 
(including motor symptoms), the national study group prioritized the following: psychological 
factors (e.g., preferences and motivation for PA and exercise, previous activity habits, 
apathy), as well as contextual factors, (i.e., the physical built, social, and attitudinal 
environment), and resources in the evaluation of exposures across the various settings 
across Sweden. For some of these explanatory factors, no standardized measures were 
available and therefore new proposed items and questions were developed; these will be 
further tested in the pilot study. More traditional PD-measures will also be included, which for 
example cover disease- and symptom severity and the presence of nonmotor symptoms, PD 
medications and other treatments. Moreover, gait velocity, balance and walking ability will 
also be assessed.  
 
Specifically, standardized questions will be used to collect information on personal factors 
(e.g. sex, age, length, weight, other diseases/comorbidities, educational level, 
socioeconomic status/income medical history, and fall history) and environmental factors 
(e.g. living situation, education, employment status, support resource in daily life and use of 
assistive devices). Questions on PD medications, health care utilization (rehab/hospital 
visits, health care contacts), other PD treatments as well as questions of PA history and 
current PA-level will be asked either through REDCap, over phone or at the clinical visit.  
 
The clinical visit will take approximately 1 to 1.5 hour and constitutes the Movement 
Disorders Society - Unified Parkinson’s Disease Rating scale (MDS-UPDRS [21] including 
the Hoeh & Yahr stages [22]), assessment of balance (Mini-BESTest including the Timed up 
and Go test [23, 24]), gait (10 meter walking test or gait analysis) and cognitive function 
(Montreal Cognitive Assessment, MoCA [25]). At the clinical visit, they will also be instructed 
how to wear an accelerometer for seven days in their home environment. 
Figure 3. Example of the ActiGraph accelerometer and its output. 

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Some of the clinical assessments are prioritized lower and will only be assessed if 
equipment is available at the sites and if the PwPD has time and energy. The assessment 
with lower priority are, assessment of cognitive function with the Ray Auditory Verbal 
Learning test (RAVLT [26] ), and pain with Kings Parkinsons Pain Scale (KPPS [27]). 
Optional and where equipment is available are measurement of body composition with 
Bioelectrical Impedance Analysis (BIA) as well as the addition of gait analysis (assessing 
cadence, velocity and step time) to the gait assessment using either a pressure sensitive 
walkway (GAITRite, CIR Systems, Inc) or wireless inertial sensors (Opal, APDM Inc) 
positioned on trunk, low back, wrists and ankles. These sensors are light-weighted; similar to 
a regular watch. Some sites will also use these sensors while assessing mobility (i.e., Timed 
Up & Go test). 
 
  
 
 
 
 
 
 
 
Questionnaires  will be administered digitally via REDCap and cover physical activity level 
(Frändin Grimby scale[28]), non-motor symptoms (Non-Motor Symptoms Questionnaire 
items, NMSQ[29, 30]), depression and anxiety (Hospital Anxiety and Depression Scale, 
HADS [31]), Walking ability (WALK-12G [32] and Freezing of gait questionnaire, FOGQsa 
[33]), balance confidence (Activities specific balance confidence, ABC scale[34]), motivation 
(Behavioural Regulation In Exercise Questionnaire, BREQ 4), disability (World health 
organization (WHO) disability assessment schedule, Whodas 2.0 [35]), executive functioning 
(Executive function questionnaire, DEX[36]), fatigue (Parkinson’s Fatigue Scale, PFS[37, 
38]), self-efficacy (Self-efficacy of exercise/PA, ESES[39]), nutrition (parts of Mini Nutritional 
Assessment (MNA[40]) score and questions about protein intake, changes in weight, 
dysphagia), sleep ( Scales for Outcomes in Parkinson's disease – Sleep, SCOPA- 
SLEEP[41]), Wellbeing (The WHO- Five Well-Being Index (WHO-5)[42])and Quality of life 
(Parkinson's Disease Questionnaire, PDQ-39 [43]). 
We estimate that all the questionnaires take approximately 1.5 h fill in therefore they will be 
administered at two or three different occasions/emails (approx. 30 min each) adjacent to the 
clinical visit to reduce fatigue filling in the forms. We will also evaluate the feasibility of all 
these questionnaires during the pilot phase and most likely reduce the battery for the larger 
cohort study. 
Clinical visit 
 
Area of assessment 
Measurement 
Motor symptoms 
MDS- UPDRS part 3-4 
Non-motor symptoms 
MDS- UPDRS part 1a 
Physical activity 
Accelerometer to wear for next seven days  
Gait 
10-meter walk test or gait analysis  
Balance 
Mini-BESTest, Timed Up and Go 
Cognition 
Montreal Cognitive Assessment (MoCA),  
Rey-Auditory Verbal Learning Test (RAVLT) 
Pain 
Kings Parkinsons Pain Scale (KPPS) 
Body composition 
Bioelectrical Impedance Analysis (BIA) 
Italic denotes lower prioritized measurements 
Questionnaires via REDCap 
Area of assessment 
Measurement 
Physical activity 
Frändin Grimby Scale 
Non-motor symptoms 
Non-Motor Symptoms Questionnaire (NMSQ), MDS-UPDRS part 1b 
Anxiety and depression 
Hospital Anxiety and Depression Scale (HADS) 
Gait 
WALK-12G questionnaire, Freezing of gait questionnaire (FOGQsa) 
Balance 
Activities specific balance confidence (ABC scale) 
Motivation 
Behavioural Regulation in Exercise Questionnaire (BREQ 4) 
ADL 
MDS-UPDRS part 2 
Disability 
World health organization (WHO) disability assessment schedule (Whodas 2.0) 
Cognition, executive function 
Executive function questionnaire (DEX)   
Fatigue 
Parkinson’s Fatigue Scale (PFS-16) 

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Pilot (feasibility) phase  
The pilot/feasibility study aims to evaluate recruitment rates and whether a diverse and 
representative population can reasonably be enrolled, as a success factor in the larger 
cohort study. To ensure that the proposed multicenter cohort study can be scaled to four 
regions of Sweden, this pilot phase aims to conduct feasibility study in at least two of the 
sites to specifically evaluate and achieve process and scientific feasibility for the definitive 
longitudinal cohort study. We will here specifically address process feasibility (i.e., 
determining recruitment rates, retention rates, viability of assessment battery in multiple 
modes, coordination between multiple sites) and scientific feasibility (i.e., safety and 
population diversity and representation as well as explore associations that might be worth 
following up in the larger study).   
 
As stated under participants, we will include PwPD diagnosed with mild to severe severity 
(H&Y1-4). The pilot study will also inform if we need additional exclusion criteria such as 
cognitive difficulties that affect the ability to understand and follow verbal/written instructions 
or adaptations in the core set to be able to include a diverse group of people with PD. 
 
Sample size: We plan to include approx. 50 PwPD (10% of the total cohort) recruited from at 
least 2 sites, preferably more to test coordination and feasibility aspects in the different sites. 
We estimate this to be representative of the target study population and also large enough to 
provide useful information about the aspects that are being assessed for feasibility [44]. 
 
Analysis: Descriptive statistics will be used to determine feasibility criteria such as 
recruitment rates, retention rates, eligibility criteria, sample PA means as well as 
characteristics of the study samples.  
 
National cohort phase  
This phase consists of the main study, a large multicenter study with open cohort design 
across Sweden. Participants diagnosed with PD with mild to severe disease severity (H&Y1-
4) will be recruited from four different geographical sites in Sweden (i.e., Lund/Malmö, 
Umeå, Göteborg, Stockholm), which differ in terms of population density, rurality (urban vs. 
rural), physical, social, and attitudinal features of the environment.  
 
We propose four data collection points in the future national cohort study, specifically at 
baseline (in-person clinical evaluation + digital questionnaires + accelerometers in home), 
one-year follow-up (digital questionnaires + accelerometers in home), 2-years follow-up 
(digital questionnaires + accelerometers in home), and, finally, 3-years follow-up (in-person 
clinical evaluation + digital questionnaires + accelerometers in home), see time plan below. 
We are anticipating that we will only make minor changes to the design and test battery after 
the pilot phase and therefore plan for an internal pilot incorporating the pilot subjects into the 
larger cohort study at the one-year follow-up.  
 
Sample size: A study conducted in Sweden involving patients with Parkinson's disease 
reported that the prevalence of decline in physical activity after one year of follow-up is 
approximately 16% (reference [45]). This study was conducted during the COVID-19 
pandemic (first and third waves). Therefore, we estimate that the prevalence of decline in 
this cohort may be slightly lower, as the pandemic did not significantly affect the Swedish 
Self-efficacy 
Self-efficacy of exercise/PA (ESES) 
Nutrition 
Mini Nutritional Assessment, questions on protein intake, weight and dysphagia 
Sleep 
Scales for Outcomes in Parkinson's disease – Sleep (SCOPA-SLEEP) 
Pain 
Visal analog scale VAS (0-100) 
Wellbeing 
The WHO- Five Well-Being Index (WHO-5) 
Quality of life 
Parkinson's Disease Questionnaire (PDQ39) 
Italic denotes lower prioritized questionnaires 

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population's physical activity levels. We expect the proportion of decline in physical activity in 
this cohort to be 10% per year, as it includes people with Parkinson's disease at various 
disease stages and ages. 
Sample size calculations were performed using a one-sample proportion test, two-sided, in 
STATA 18. We assume a decline rate of 20% after two years follow-up and an alternative 
proportion of 26% (16% + 10%), with a power of 80% and a significance level (alpha) of 
0.05. With an estimated 20% drop-off that would result in 478 participants. Hence, we 
anticipate including 500 patients of different disease stages and ages. 
 
Analysis: Baseline assessments of PA and exposures will be used to identify potential risk 
factors for PA behavior, i.e. volume and intensity. Following on, all risk factors - more 
specifically those “unexposed” for some participants at baseline - will be analyzed to observe 
if their (exposures) emergence impacted the outcome of interest. Using multivariate/multi-
level modelling/ or LASSO regressions will allow for the identification of clusters of predictors 
as these were prospectively and longitudinally identified. The Biostatistics Core Facility at KI 
has been involved in the power analysis and will be involved in analysis of data.  
 
Qualitative interviews (sub study) 
To more deeply describe physical activity and everyday activities and explore the barriers 
and facilitators of physical activity among PwPD, we will perform semi-structured interviews 
which are the most widely used interviewing format for qualitative research. The interviews 
will be organized around a set of predetermined open-ended questions, with additional 
questions and discussion points emerging from the dialogue [46]. We will strive for diversity 
and recruit participants from all sites and hold interviews digitally (Zoom/Teams) or at a 
preferred location (home or clinic) if possible and expect that each session will take 
approximately 1 to 1.5 hours. The sessions will be audio recorded. The interviewer will be 
prepared to tailor the interview questions and communication style to the patients’ 
capabilities, and in case of cognitive impairment, to adopt strategies suggested to optimize 
communication with patients with cognitive deficits [47].  
Sample size: For the qualitative sub study, study participants will be consecutively included 
using a varied sampling method until data saturation is reached. We here anticipate a 
sample of 15-20 PwPD to reach saturation in accordance with previous literature [48].  
Analysis: The interview transcripts will be systematically analyzed using standard 
procedures for qualitative content analysis according to published guidelines. More 
specifically, we will use thematic qualitative content analysis - a replicable and valid method 
for text data analysis. During data analysis the research team will mainly strive for an 
inductive approach to category development, by allowing categories to emerge from the data 
[49, 50]. 
 
National study group 
The already established national expert group consists of Academics and health care 
professionals with diverse experience in clinical therapy service delivery and research of 
the PD population from several regions in Sweden. This group covers different ages, 
experiences, four regions as well as several disciplines and professions. Most have joint 
positions between health care and academia facilitating implementation.  
 
The sites responsible are professor Erika Franzén (PI) from Karolinska Institute (KI) and 
Karolinska University Hospital (K), Stockholm, associate professor Maria H Nilsson, at Lund 
University and the Memory Clinic, Department of Neurology, Rehabilitation Medicine, Skåne 
University Hospital, Skåne County Council, professor Filip Bergquist University of 
Gothenburg and University Hospital Senior Consultant at the Neurology clinic at 
Sahlgrenska Academy, Västra Götaland County Council and postdoc Gudrun Johansson 
Department of Community Medicine and Rehabilitation at Umeå University and 

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physiotherapist at the Neuro- and Stroke rehabilitation clinic at University Hospital of Umeå, 
County Council of Västerbotten.  
 
The group also includes Conran Joseph, associate professor at Stellenbosch University, 
South Africa; expert in epidemiologic designs in neurological disorders, Susanne Guidetti, 
professor/ occupational therapist, Peter Hagell, professor/nurse, David Moulaee 
Conradsson associate professor/physiotherapist, Maria Hagströmer professor/ 
physiotherapist, Urban Ekman, associate professor/psychologist, Franziska Albrecht 
assistant professor/neurobiologist and Gerd Faxén-Irving, PhD/Docent and dietician as well 
as other clinicians at the four sites and not least people with PD and representative from the 
Swedish Parkinson Association (Parkinsonförbundet). 
 
Ethical considerations 
The testing procedure will not include any additional risks compared to regular clinical 
assessments as most of the clinical tests and questionnaires included in this proposal are 
part of regular clinical assessments of PwPD. However, there might be a risk of responder 
burden due to the extensive questionnaires and therefore this will be an important feasibility 
factor in the pilot phase.   
 
While testing gait and balance in populations with impaired balance (e.g. PD) or older adults 
there is always a risk of instability and falls. Therefore, participants will not be asked to walk 
faster than they are comfortable with, and the test leader will be positioned close to the 
participants during all testing to prevent them from falling in case of a trip or slip. If needed, 
participants with more severe balance impairments will be equipped with a safety belt to 
ensure further safety. Consideration for fatigue during testing has been made and breaks in 
the protocol have been set up. 
 
The instruments used to measure physical activity (accelerometer) are non-invasive 
methods without any documented associated risks for the individual. Furthermore, the size 
of the accelerometer is similar to a normal wristwatch and will not interfere with the ability of 
the participant to perform daily activities.  
 
All data will be analyzed on a group level, and all data will be pseudonymized; the code key 
to connect individual with data will be kept secured and encrypted. Data will be stored as 
paper and digitally in accordance with regulations of public authority archives and the 
General Data Protection Regulation.  
Significance and clinical relevance 
This project includes people with PD and non-profit organisations in the design, 
development, and implementation of the pilot/feasibility and future national cohort study. 
Importantly, end users and PD organisations are active members of the already established 
national steering committee for this project; they have engaged in several workshops and 
decision-making processes (voting) since the inception. End users are seen as equal 
partners with experiential knowledge and lived experiences, which is invaluable in ensuring 
that societal questions of high priority are pursued.  
The clinical relevance of this project is in understanding how PA evolve and how it is 
influenced, in a diverse and representative group of PwPD across Sweden. This includes the 
role of contextual factors which is difficult to capture comprehensively. Developing a more 
holistic explanatory framework for PA in Sweden can help unravel unique intervention 
components to be targeted in future clinical therapy trials. 
 
This project has the potential of improving our understanding of PA and subtypes in PwPD, 
enabling more person-centered interventions and prevention strategies, and thereby using 
the health care system more effectively. This work could also inform the importance of PA as 

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an essential factor in screening and support in the diagnosis of PD, especially early onset 
PD and further strengthen the multidisciplinary management of PD. 
 
 Time plan 
The pilot study will start during spring 2025 with setting up the sites, educating the data 
assessors/physical therapists as well as setting up routines for measurements, data 
management, storing and communication. Thereafter the data collection will begin, and sites 
will join in when ready for collecting data. The pilot will run during 2025 and 2026, and we 
will continuously follow the feasibility and adapt minor changes to the protocol, design and 
coordination. If there are no major changes, we will conduct an internal pilot and integrate 
the pilot subjects into the follow-up assessments of the larger study. The national cohort 
study will most likely go on until 2032 depending on the sample size and recruiting rates.  
The qualitative sub study will be performed during 2026 and 2027.   
 
 
 
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