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Parkinson DiseaseMOVE ON UPNCT07705620

A Behavioral Digital Intervention For Parkinson's Disease

A study testing Digital Exercise Program in people with Parkinson Disease and Exercise Training, run by Egas Moniz - Cooperativa de Ensino Superior, CRL.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease, Exercise Training
What is being tested?
Digital Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
No sites listed yet
Study dates
2 Nov 2026to 30 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of idiopathic Parkinson's disease (self-reported; verification requested from treating physician or neurologist when possible)
  • Hoehn and Yahr stages I-IV (mild to moderate disease severity; ambulatory with or without assistance)
  • Age 18 years or older
  • Access to a computer, tablet, or smartphone with reliable internet connection
  • Basic digital literacy to navigate the study website (caregiver assistance permitted if needed)
  • Ability to communicate with study personnel in the local language (Portuguese, Greek, Croatian, or Italian) to understand instructions and provide informed consent
  • Willingness and ability to provide written informed consent electronically prior to enrolment
  • For those completing remote assessments, willingness to complete self-assessments with or without caregiver assistance following provided video instructions

Who cannot join

  • Self-reported severe cognitive impairment that would preclude understanding and following exercise instructions, based on clinical judgment of referring provider or study coordinator following screening conversation
  • Significant active psychiatric problems (e.g., untreated major depression, psychosis, substance abuse) that would interfere with participation or adherence
  • Medical conditions contraindicating moderate-intensity exercise, including:
  • 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
  • Pregnancy
  • Anticipated inability to complete the 8-week intervention period due to planned surgery, extended travel, or other commitments
  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Xavier Melo, PhD contact

+351 212946700

xmelo@egasmoniz.edu.pt

About this study

Official title: A Behavioral Digital Intervention For Parkinson's Disease: Protocol For A Quasi-Experimental Study Examining Feasibility, Physical Activity, And Exploratory Patient-Reported Outcomes

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:

Read more
  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.
Read the detailed description

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.

Being tested
Digital Exercise Program
Keywords
Parkinson's Disease, Dual-Task Training, Digital Health, Exercise, Behavioral Intervention
Medical subject headings
Parkinson Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital Exercise ProgramBehavioural

    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.

Study groups in NCT07705620
Study groupRoleWhat they receive
Digital Exercise ProgramExperimentalNot described
Receives: Behavioral: Digital Exercise Program
Usual CareNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (Week 0) and Post-Intervention (Week 9)

Secondary outcomes (5)

  1. 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.

    Measured: Baseline (Week 0) and Post-Intervention (Week 9)

  2. 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).

    Measured: Baseline (Week 0) and Post-Intervention (Week 9)

  3. 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).

    Measured: Baseline (Week 0) and Post-Intervention (Week 9)

  4. 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).

    Measured: Baseline (Week 0) and Post-Intervention (Week 9)

  5. 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.

    Measured: Baseline (Week 0) and Post-Intervention (Week 9)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2026
  2. Study start2 Nov 2026 (estimated)
  3. Primary completion30 Jul 2027 (estimated)
  4. Study completion30 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07705620
Sponsor's protocol ID
MOVE ON UP
Other IDs
101182755
Acronym
MOVE ON UP
Status last verified
Jul 2026
First submitted
10 Jul 2026
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 21513547

  • 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.

    PubMed 29623949

  • 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.

    PubMed 36548037

  • 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.

    PubMed 30715489

  • 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.

    PubMed 28440888

  • 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.

    PubMed 32925106

  • 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.

    PubMed 38640167

  • 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.

    PubMed 32917125

  • 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.

    PubMed 32598094

  • 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.

    PubMed 30584159

Questions about this trial

What is this clinical trial studying?

A study testing Digital Exercise Program in people with Parkinson Disease and Exercise Training, run by Egas Moniz - Cooperativa de Ensino Superior, CRL.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xavier Melo, PhD (+351 212946700, xmelo@egasmoniz.edu.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Physical Activity Levels (time frame: Baseline (Week 0) and Post-Intervention (Week 9)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07705620, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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