A Behavioral Digital Intervention For Parkinson's Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEgas Moniz - Cooperativa de Ensino Superior, CRL

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Pregnancy

Anticipated inability to complete the 8-week intervention period due to planned surgery, extended travel, or other commitments

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Digital Exercise ProgramExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

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.

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

Secondary outcomes

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.

Time frame
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).

Time frame
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).

Time frame
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).

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

Other outcomes

1

Program Acceptability and Satisfaction

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.

Time frame
Post-Intervention (Week 9)
2

Barriers and Facilitators to Physical Activity

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.

Time frame
Baseline (Week 0)

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Egas Moniz - Cooperativa de Ensino Superior, CRL

Lead sponsor

Young Parkies Portugal

Collaborator

Aristotle University Of Thessaloniki

Collaborator

Università degli Studi "G. d'Annunzio" Chieti-Pescara

Collaborator

Omišalj-Njivice Gymnastics Club

Collaborator

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