A Behavioral Digital Intervention For Parkinson's Disease

NCT07705620 | Not Yet Recruiting

• 2 other identifiers: MOVE ON UP101182755
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Is the MOVE ON UP digital intervention feasible and acceptable, based on recruitment, retention, adherence, and safety?
2. 2.Does participation in the program lead to increased physical activity levels?
3. 3.Does the intervention produce exploratory improvements in patient-reported outcomes such as motor symptoms, balance confidence, and quality of life?
4. 4.Complete baseline and post-intervention assessments of physical activity and patient-reported outcomes.
5. 5.Engage in an 8-week digital dual-task exercise program, including:
6. 6.Use the digital platform to follow the program and complete follow-up questionnaires.

Conditions

Parkinson Disease; Exercise Training

Keywords

Parkinson's Disease; Dual-Task Training; Digital Health; Exercise; Behavioral Intervention

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

• Change in Fear of Falling

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

• Change in Freezing of Gait Severity

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

• Change in Quality of Life

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

• Change in Exercise Self-Efficacy

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

• Change in Psychological Determinants

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

Other Outcomes (2)

• Program Acceptability and Satisfaction

  Post-Intervention (Week 9)

• Barriers and Facilitators to Physical Activity

  Baseline (Week 0)

Study Arms (2)

Digital Exercise Program

EXPERIMENTAL

Behavioral: Digital Exercise Program

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.

Interventions

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.

Digital Exercise Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Egas Moniz - Cooperativa de Ensino Superior, CRL: lead
• Young Parkies Portugal: collaborator
• Aristotle University Of Thessaloniki: collaborator
• Università degli Studi "G. d'Annunzio" Chieti-Pescara: collaborator
• Omišalj-Njivice Gymnastics Club: collaborator

Related Publications (10)

• 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.

  PMID: 21513547 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.

  PMID: 29623949 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.

  PMID: 36548037 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.

  PMID: 30715489 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.

  PMID: 28440888 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.

  PMID: 32925106 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.

  PMID: 38640167 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.

  PMID: 32917125 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.

  PMID: 32598094 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.

  PMID: 30584159 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Study Officials

• João Vaz, PhD

  Egas Moniz School of Health and Science

  STUDY CHAIR

Central Study Contacts

Xavier Melo, PhD

CONTACT

+351 212946700; xmelo@egasmoniz.edu.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start (Estimated): November 2, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 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 Criteria: 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