A Randomised Controlled Feasibility Study of a Novel Technology-assisted Home Based Aerobic Exercise Programme for Individuals With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Adherence to exercise program
研究概览
简要总结
This study aim to evaluate the (1) feasibility of a novel mobile application ( Combat PD) that support a home-based gamified aerobic exercise program in individuals with mild Parkinson's disease (PD).
The study aims to further explore (2) the effectiveness of Combat PD in improving adherence to prescribed home-based exercise program; and (3) the clinical effectiveness if combat PD in improving motor and non-motor function in PD.
详细描述
This study aim to evaluate the (1) feasibility of a novel mobile application ( Combat PD) that support a home-based gamified aerobic exercise program in individuals with mild Parkinson's disease (PD).
The study aims to further explore (2) the effectiveness of Combat PD in improving adherence to prescribed home-based exercise program; and (3) the clinical effectiveness if combat PD in improving motor and non-motor function in PD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patient blinding will be done by ensuring that patients are unaware of the content of either treatment group before participation, and will only be made aware of the content of their allocated programme after randomization. They will be instructed not to share the details of their exercise programme with their physicians or other study participants, and to only contact their assigned physiotherapist in case of any problems during the study. Intervention and control group participants will be assigned different dates for study site visits to avoid cross-contamination.
Study team members who will assess outcomes or perform data analyses will be masked to group allocation.
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 30-75, diagnosed with Parkinson's disease, with mild disease severity (Hoehn and Yahr stages I to II)
- •Sedentary lifestyle
- •Receive a stable dose of dopaminergic medication for at least 4 weeks prior to study inclusion
- •Has a smart phone device
排除标准
- •Uncontrolled hypertension, arrhythmia, or unstable cardiovascular status
- •Poorly controlled diabetes mellitus
- •Advanced kidney disease
- •Recent cerebrovascular event/ concussion/ fall in the last 6 months
- •Significant cognitive impairment (MoCA<21)
- •Any other medical/orthopaedic/psychiatric condition that would interfere with ability to participate in the study
- •No stable internet or smart device access
- •Inability to fill up self-reported questionnaires
- •Attendance at any regular exercise programme up to 4 weeks prior to study inclusion
结局指标
主要结局
Adherence to exercise program
时间窗: 12 weeks
actual exercise frequency compared to prescribed exercise targets.
次要结局
- Dual-task Timed Up and Go Test (TUG)(12 weeks)
- Montreal Cognitive Assessment (MoCA)(12 weeks)
- Scales for Outcomes in Parkinson's disease (SCOPA-sleep)(12 weeks)
- Timed Up and Go test (TUG)(12 weeks)
- Adverse events(12 weeks)
- Motor section of Movement Disorder Society sponsored Unified Parkinson's disease Rating Scale (MDS-UPDRS-III)(12 weeks)
- 6-minute walk test(12 weeks)
- Fatigue Severity Scale (FSS)(12 weeks)
- Parkinson Disease Questionnaire (PDQ)-8(12 weeks)
- Hospital Anxiety and Depression Scale (HADS)(12 weeks)
研究者
Chloe Chung Lau Ha
Principal Physiotherapist
Tan Tock Seng Hospital