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| ID | Type | Description | Link |
|---|---|---|---|
| 101182755 | Other Grant/Funding Number | EUROPEAN EDUCATION AND CULTURE EXECUTIVE AGENCY |
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| Name | Class |
|---|---|
| Young Parkies Portugal | UNKNOWN |
| Aristotle University Of Thessaloniki | OTHER |
| Università degli Studi "G. d'Annunzio" Chieti-Pescara | UNKNOWN |
| Omišalj-Njivice Gymnastics Club |
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The goal of this interventional, quasi-experimental study is to evaluate whether a digital dual-task exercise and behavioral program can improve physical activity and influence patient-reported outcomes in people with Parkinson's disease.
The main questions it aims to answer are:
Because the study includes a comparison group, researchers will compare participants receiving the MOVE ON UP digital intervention with participants receiving usual care to determine whether the digital program produces measurable behavioral and functional changes.
Participants will:
Complete baseline and post-intervention assessments of physical activity and patient-reported outcomes.
Engage in an 8-week digital dual-task exercise program, including:
2.1 Structured dual-task exercise sessions delivered digitally. 2.2 Educational content related to Parkinson's disease and physical activity. 2.3 Behavioral support elements informed by the COM-B model.
Use the digital platform to follow the program and complete follow-up questionnaires.
This study employs a quasi-experimental, multicenter, two-arm design to evaluate the feasibility, acceptability, and preliminary efficacy of the MOVE ON UP digital exercise program as a complement to usual care. The study will be conducted across four European countries: Portugal, Greece, Croatia, and Italy, involving partner organizations Egas Moniz School of Health & Science (EM, Portugal), Young Parkies Portugal (YP, Portugal), Aristotle University of Thessaloniki (AUT, Greece), Omišalj-Njivice Gymnastics Club (GON, Croatia), and Università degli Studi "G. d'Annunzio" Chieti-Pescara (UdA, Italy).
All participants will continue their usual medical care and ongoing activities throughout the study period. The intervention group will receive the 8-week digital exercise program in addition to usual care. A non-randomized comparison group will receive usual care alone. This design allows preliminary comparison of outcomes between those receiving the digital program and those continuing with standard care, while maintaining feasibility across sites.
The primary outcomes are feasibility (recruitment, retention, adherence, safety) and change in physical activity levels (primary behavioral outcome). Secondary outcomes include patient-reported changes in motor symptoms, balance confidence, quality of life, and psychological determinants. Randomization was not deemed appropriate at this stage given the primary objective of evaluating a newly developed digital program and the logistical constraints of a four-country multicenter design. The study will be reported in accordance with the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) statement guidelines.
The study comprises three distinct phases spanning approximately 14 weeks per participant: 1) screening and baseline assessment (Week 0), 2) 8-week intervention period (Weeks 1-8), and 3) post-intervention assessment (Week 9).
Screening and Enrolment (Week 0): Potential participants expressing interest through partner organization outreach, stakeholder networks, and social media campaigns will be directed to the MOVE ON UP study website. After registering and providing initial electronic consent, candidates will complete an online screening questionnaire to assess eligibility. Eligible individuals will receive detailed study information and informed consent will be obtained electronically prior to any study procedures.
STUDY SETTINGS The study is conducted entirely in community settings across four countries from January to July 2027. The intervention is delivered remotely via the MOVE ON UP MOOC, available at https://moveonup.csd.auth.gr (the platform is accessible at https://moveonup.csd.auth.gr/mooc/), from participants' homes using personal computers, tablets, or smartphones with internet connection. Telephone and email support is available if technical difficulties arise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Exercise Program | Experimental |
| |
| Usual Care | No Intervention | Participants continue usual medical care and ongoing activities. No access to the digital exercise program during the 8-week study period. Complimentary access to the full program is offered after study completion. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Exercise Program | Behavioral | 8-week asynchronous digital program for Parkinson's disease, delivered via online platform (Moodle). Three integrated components: (1) 6 educational lectures (45-60 min) covering balanced exercise routines, overcoming barriers, dual-task training rationale, voice integration, technology use, and online exercise; (2) 24 pre-recorded exercise sessions (3/week, 60 min) combining physical movements with cognitive challenges and vocal responses, progressing from foundational dual-task training to attention consolidation; sessions require minimal equipment (chair, 3m space); (3) automated COM-B-based text messages targeting capability, opportunity, and motivation delivered in weekly blocks. Platform features include progress tracking, reminders after 72h inactivity, discussion forums, and technical support. Grounded in behavior change theory and developed with input from people with Parkinson's, caregivers, and clinicians. Accessible via computer, tablet, or smartphone. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Activity Levels | Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ) - Short Form, a 7-item self-report instrument assessing time spent walking, in moderate-intensity activity, and in vigorous-intensity activity over the preceding week. Total physical activity will be calculated as MET-minutes per week using standard IPAQ scoring protocols: walking MET-min/week = walking minutes × walking days × 3.3 METs; moderate-intensity MET-min/week = moderate minutes × moderate days × 4.0 METs; vigorous-intensity MET-min/week = vigorous minutes × vigorous days × 8.0 METs. These are summed to yield total MET-min/week. Minutes per week of moderate-to-vigorous physical activity (MVPA) will also be calculated separately, and the proportion of participants meeting international physical activity recommendations (≥150 minutes of MVPA per week or ≥600 MET-min/week) will be reported. | Baseline (Week 0) and Post-Intervention (Week 9) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fear of Falling | Assessed using the Falls Efficacy Scale International (FES-I), a 16-item self-report questionnaire assessing fear of falling during indoor and outdoor activities. Items are rated 1-4 (not at all concerned to very concerned), with total scores ranging 16-64. Higher scores indicate greater fear of falling. The FES-I shows excellent internal consistency (α = 0.96-0.98) and test-retest reliability (ICC = 0.91-0.94) in Parkinson's disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Program Acceptability and Satisfaction | Assessed using the MOVE ON UP Participant Satisfaction Questionnaire, a 6-item measure rated on 5-point Likert scales (1 = Strongly Disagree to 5 = Strongly Agree) assessing: (1) ease of understanding; (2) ease of operationalizing instructions; (3) content appropriateness for people with Parkinson's; (4) content relevance to daily life; (5) program length (8 weeks, 3 sessions/week); and (6) likelihood of recommending the program to a friend with Parkinson's. Total scores range from 6 to 30, with higher scores indicating greater program satisfaction and acceptability. Open-ended questions will elicit qualitative feedback on barriers, facilitators, and suggestions for improvement. |
Inclusion Criteria:
Exclusion Criteria:
Unstable cardiovascular disease (uncontrolled hypertension, recent myocardial infarction, unstable angina) Severe orthopedic limitations (acute fractures, severe osteoarthritis limiting mobility) Other systemic conditions that would make participation unsafe as determined by the participant's physician or study coordinator during screening
Participants with a caregiver willing to assist with technology, assessments, or exercise supervision are not excluded; caregiver involvement will be documented and considered in exploratory analyses where appropriate.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xavier Melo, PhD | Contact | +351 212946700 | xmelo@egasmoniz.edu.pt |
| Name | Affiliation | Role |
|---|---|---|
| João Vaz, PhD | Egas Moniz School of Health and Science | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21513547 | Background | Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42. | |
| 29623949 | Background | Dorsey ER, Glidden AM, Holloway MR, Birbeck GL, Schwamm LH. Teleneurology and mobile technologies: the future of neurological care. Nat Rev Neurol. 2018 May;14(5):285-297. doi: 10.1038/nrneurol.2018.31. Epub 2018 Apr 6. |
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Data obtained in this study may be provided to qualified researchers with academic interest in digital exercise for people with parkinson's. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact xmelo@egasmoniz.edu.pt
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| UNKNOWN |
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| Baseline (Week 0) and Post-Intervention (Week 9) |
| Change in Freezing of Gait Severity | Assessed using the New Freezing of Gait Questionnaire (NFOG-Q), a 9-item self-report instrument assessing freezing episodes, frequency, duration, and impact on daily life. Items are scored on a 0-4 scale; higher scores indicate greater freezing severity. Participants view a video demonstration of freezing episodes before completing the questionnaire to ensure accurate perception. The NFOG-Q demonstrates excellent internal consistency (α = 0.91) and validity in Parkinson's disease (ICC = 0.88). | Baseline (Week 0) and Post-Intervention (Week 9) |
| Change in Quality of Life | Assessed using the Parkinson's Disease Questionnaire-8 (PDQ-8), the short form of the PDQ-39. This 8-item instrument assesses quality of life across eight domains: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort (one item per domain). Items are rated 0-4 (never to always) and transformed to a 0-100 scale, with higher scores indicating worse quality of life. The PDQ-8 demonstrates acceptable test-retest reliability (ICC = 0.76-0.93) and internal consistency (α = 0.72-0.95), and is strongly correlated with the full PDQ-39 (r = 0.94-0.97). | Baseline (Week 0) and Post-Intervention (Week 9) |
| Change in Exercise Self-Efficacy | Assessed using the Exercise Self-Efficacy Scale (ESES), a 10-item self-report instrument measuring confidence in maintaining exercise despite barriers (e.g., fatigue, pain, time constraints). Items are rated on a 4-point scale (1 = Not always true to 4 = Always true). Total scores range from 10-40, with higher scores indicating greater self-efficacy for exercise. The ESES demonstrates moderate test-retest reliability in Parkinson's disease (ICC = 0.66). | Baseline (Week 0) and Post-Intervention (Week 9) |
| Change in Psychological Determinants | Assessed using the COM-B Self-Evaluation Questionnaire, a validated 6-item measure assessing perceived capability (physical and psychological), opportunity (physical and social), and motivation (reflective and automatic) for engaging in regular physical activity and exercise. Items are rated on a 10-point scale from 1 (Strongly Disagree) to 10 (Strongly Agree). Total scores range from 6-60, with higher scores indicating greater perceived capability, opportunity, and motivation. The questionnaire demonstrates acceptable test-retest reliability (ICC = 0.55-0.83) and construct validity. | Baseline (Week 0) and Post-Intervention (Week 9) |
| Post-Intervention (Week 9) |
| Barriers and Facilitators to Physical Activity | Assessed at baseline using a tailored questionnaire developed based on a literature review of common barriers and facilitators to physical activity in people with Parkinson's disease. The questionnaire consists of 32 items asking participants to rate the extent to which each barrier affects their ability to engage in physical activity. Items are rated on a 5-point Likert scale (1 = Strongly disagree to 5 = Strongly agree). Individual items are analyzed descriptively; no total score is calculated. Responses will inform personalization of COM-B-based message prompts and allow for subgroup analyses of intervention response based on baseline barrier profiles. | Baseline (Week 0) |
| 36548037 | Background | Domingos J, Dean J, Fernandes JB, Godinho C. An Online Dual-Task Cognitive and Motor Exercise Program for Individuals With Parkinson Disease (PD3 Move Program): Acceptability Study. JMIR Aging. 2022 Dec 22;5(4):e40325. doi: 10.2196/40325. |
| 30715489 | Background | Ellis TD, Cavanaugh JT, DeAngelis T, Hendron K, Thomas CA, Saint-Hilaire M, Pencina K, Latham NK. Comparative Effectiveness of mHealth-Supported Exercise Compared With Exercise Alone for People With Parkinson Disease: Randomized Controlled Pilot Study. Phys Ther. 2019 Feb 1;99(2):203-216. doi: 10.1093/ptj/pzy131. |
| 28440888 | Background | Strouwen C, Molenaar EALM, Munks L, Keus SHJ, Zijlmans JCM, Vandenberghe W, Bloem BR, Nieuwboer A. Training dual tasks together or apart in Parkinson's disease: Results from the DUALITY trial. Mov Disord. 2017 Aug;32(8):1201-1210. doi: 10.1002/mds.27014. Epub 2017 Apr 25. |
| 32925106 | Background | Schootemeijer S, van der Kolk NM, Ellis T, Mirelman A, Nieuwboer A, Nieuwhof F, Schwarzschild MA, de Vries NM, Bloem BR. Barriers and Motivators to Engage in Exercise for Persons with Parkinson's Disease. J Parkinsons Dis. 2020;10(4):1293-1299. doi: 10.3233/JPD-202247. |
| 38640167 | Background | Li J, Aulakh N, Culum I, Roberts AC. Adherence to Non-Pharmacological Interventions in Parkinson's Disease: A Rapid Evidence Assessment of the Literature. J Parkinsons Dis. 2024;14(s1):S35-S52. doi: 10.3233/JPD-230266. |
| 32917125 | Background | Radder DLM, Ligia Silva de Lima A, Domingos J, Keus SHJ, van Nimwegen M, Bloem BR, de Vries NM. Physiotherapy in Parkinson's Disease: A Meta-Analysis of Present Treatment Modalities. Neurorehabil Neural Repair. 2020 Oct;34(10):871-880. doi: 10.1177/1545968320952799. Epub 2020 Sep 11. |
| 32598094 | Background | Rajan R, Brennan L, Bloem BR, Dahodwala N, Gardner J, Goldman JG, Grimes DA, Iansek R, Kovacs N, McGinley J, Parashos SA, Piemonte MEP, Eggers C. Integrated Care in Parkinson's Disease: A Systematic Review and Meta-Analysis. Mov Disord. 2020 Sep;35(9):1509-1531. doi: 10.1002/mds.28097. Epub 2020 Jun 29. |
| 30584159 | Background | Dorsey ER, Sherer T, Okun MS, Bloem BR. The Emerging Evidence of the Parkinson Pandemic. J Parkinsons Dis. 2018;8(s1):S3-S8. doi: 10.3233/JPD-181474. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001519 | Behavior |