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: 1. Is the MOVE ON UP digital intervention feasible and acceptable, based on recruitment, retention, adherence, and safety? 2. Does participation in the program lead to increased physical activity levels? 3. Does the intervention produce exploratory improvements in patient-reported outcomes such as motor symptoms, balance confidence, and quality of life? 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: 1. Complete baseline and post-intervention assessments of physical activity and patient-reported outcomes. 2. 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. 3. 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. 1. Baseline Assessment (Week 0): All enrolled participants will complete a comprehensive baseline assessment battery. All participants, regardless of group, will receive login credentials to access the study website and complete the following assessments at baseline and post-intervention: (1) primary outcome-physical activity levels measured by the International Physical Activity Questionnaire (IPAQ); (2) secondary outcomes-balance (Falls Efficacy Scale International \[FES-I\]), quality of life (Parkinson's Disease Questionnaire-8 \[PDQ-8\]) , and psychological determinants (Exercise Self-Efficacy Scale \[ESES\], COM-B Self-Evaluation Questionnaire) ; (3) demographic and clinical information including age, sex, disease duration, Hoehn and Yahr stage, current medications, and exercise history. 2. Intervention Period (Weeks 1-8): Following completion of baseline assessments, participants in the intervention group will receive access to the MOVE ON UP digital exercise program via the same platform. The intervention consists of three components: (1) 6 educational lectures (45-60 minutes each) covering topics relevant to exercise and PD; (2) three weekly 60-minute pre-recorded exercise sessions for 8 weeks (24 sessions total) , each combining physical exercises with embedded cognitive challenges requiring both movement and vocal responses; and (3) automated theory-driven text messages targeting COM-B components (capability, opportunity, motivation), delivered in weekly blocks with content tailored to the adoption, maintenance, and consolidation phases of behavior change. Participants are encouraged to complete sessions at consistent times and utilize the website's progress tracking features. Automated reminders are sent if no activity is detected for 72 hours. A support system will allow participants to submit questions to regional staff, with responses provided within 48 hours. Discussion forums enable asynchronous peer interaction. 3. Post-Intervention Assessment (Week 9): Within one week of completing the 8-week program, all participants will complete the full assessment battery again, following identical procedures to baseline. Additionally, all participants will complete a program satisfaction questionnaire assessing ease of understanding, ease of operationalizing instructions, content appropriateness, content relevance, content innovation, program length, and likelihood of recommending the program to a friend, rated on 5-point Likert scales. 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
68
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.
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.
Time frame: Baseline (Week 0) and Post-Intervention (Week 9)
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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Baseline (Week 0) and Post-Intervention (Week 9)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.