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NCT07705620

A Behavioral Digital Intervention For Parkinson's Disease

Sponsor: Egas Moniz - Cooperativa de Ensino Superior, CRL

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-11-02

Completion Date

2027-07-30

Last Updated

2026-07-15

Healthy Volunteers

Conditions

Parkinson Disease Exercise Training

Interventions

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.

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.