A Behavioral Digital Intervention For Parkinson's Disease: Protocol For A Quasi-Experimental Study Examining Feasibility, Physical Activity, And Exploratory Patient-Reported Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 主要终点
- Change in Physical Activity Levels
研究概览
简要总结
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:
- Is the MOVE ON UP digital intervention feasible and acceptable, based on recruitment, retention, adherence, and safety?
- Does participation in the program lead to increased physical activity levels?
- 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:
- Complete baseline and post-intervention assessments of physical activity and patient-reported outcomes.
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Digital Exercise Program
干预措施: Digital Exercise Program (Behavioral)
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.
结局指标
主要结局
Change in Physical Activity Levels
时间窗: 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.
次要结局
- 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))