A Behavioral Digital Intervention For Parkinson's Disease (MOVE ON UP)

July 14, 2026 updated by: Egas Moniz - Cooperativa de Ensino Superior, CRL

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:

  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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digital Exercise Program
Behavioral: Digital Exercise Program
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.
No Intervention: Usual Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Physical Activity Levels
Time Frame: Baseline (Week 0) and Post-Intervention (Week 9)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fear of Falling
Time Frame: Baseline (Week 0) and Post-Intervention (Week 9)
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.
Baseline (Week 0) and Post-Intervention (Week 9)
Change in Freezing of Gait Severity
Time Frame: Baseline (Week 0) and Post-Intervention (Week 9)
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
Time Frame: Baseline (Week 0) and Post-Intervention (Week 9)
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
Time Frame: Baseline (Week 0) and Post-Intervention (Week 9)
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
Time Frame: Baseline (Week 0) and Post-Intervention (Week 9)
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Program Acceptability and Satisfaction
Time Frame: Post-Intervention (Week 9)
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.
Post-Intervention (Week 9)
Barriers and Facilitators to Physical Activity
Time Frame: Baseline (Week 0)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Egas Moniz - Cooperativa de Ensino Superior, CRL

Collaborators

Aristotle University Of Thessaloniki
Young Parkies Portugal
Università degli Studi "G. d'Annunzio" Chieti-Pescara
Omišalj-Njivice Gymnastics Club

Investigators

  • Study Chair: João Vaz, PhD, Egas Moniz School of Health and Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 2, 2026

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

July 30, 2027

Study Registration Dates

First Submitted

July 10, 2026

First Submitted That Met QC Criteria

July 10, 2026

First Posted (Actual)

July 15, 2026

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOVE ON UP
  • 101182755 (Other Grant/Funding Number: EUROPEAN EDUCATION AND CULTURE EXECUTIVE AGENCY)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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