NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Behavioral Digital Intervention For Parkinson's Disease
A Behavioral Digital Intervention For Parkinson's Disease

NCT07705620

Not Yet RecruitingNA

Sponsor: Egas Moniz - Cooperativa de Ensino Superior, CRL

Conditions: Parkinson Disease, Exercise Training

Interventions: Digital Exercise Program

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 overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.