Enhanced Tai Chi: A Randomised, Controlled, Single-Site Study of the Effects of Enhanced Tai Chi Training on Motor and Non-Motor Symptoms of Parkinson's Disease: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in motor symptoms (MDS-UPDRS Part III)
研究概览
简要总结
This pilot study evaluates whether a structured, Parkinson's disease-specific Tai Chi programme ("Enhanced Tai Chi") can improve motor and non-motor symptoms in people with Parkinson's disease (PD).
PD is a progressive neurological condition associated with motor impairments such as bradykinesia, rigidity, gait disturbance and postural instability, as well as non-motor symptoms including fatigue, pain, mood disturbance, sleep problems and cognitive changes. Although pharmacological treatments improve many motor symptoms, balance and postural control often respond poorly, contributing to falls and reduced independence.
Enhanced Tai Chi is a tailored programme developed specifically for people with PD, incorporating elements of Tai Chi and Qi Gong focused on balance control, coordination, postural alignment, body awareness and confidence in movement. This single-site, randomised, controlled pilot trial will enrol 30 adults with idiopathic PD (Hoehn & Yahr stages I-III), randomised in a 2:1 ratio to Enhanced Tai Chi plus usual clinical care or usual clinical care alone.
Participants in the intervention group will complete 36 supervised one-hour sessions over 12 weeks (three sessions per week: one in-person and two delivered remotely), with optional independent practice encouraged. Adherence will be monitored through attendance records. Outcomes will be assessed at baseline, post-intervention and 3-month follow-up. Findings will inform feasibility, acceptability and preliminary efficacy estimates to support the design of a future definitive randomised controlled trial.
详细描述
Background and Rationale
Parkinson's disease (PD) is a progressive neurodegenerative disorder characterised by motor and non-motor symptoms that substantially affect quality of life and functional independence. While dopaminergic therapies remain the cornerstone of treatment, symptoms such as balance impairment and postural instability often respond incompletely, increasing the risk of falls and injury. Exercise-based interventions are increasingly recommended as adjunctive therapies in PD and may improve mobility, balance, non-motor symptoms and overall quality of life.
Tai Chi and related mind-body practices emphasise slow, controlled movements, weight shifting, postural control, breathing and mental focus. Previous studies suggest Tai Chi may improve balance and reduce falls in people with PD; however, many trials vary in methodological quality and provide limited detail regarding intervention content. Enhanced Tai Chi for Parkinson's (Enhanced-Tai-Chi-PD) was developed to address these limitations by providing a structured, PD-specific programme targeting balance, proprioception, coordination and movement confidence.
Study Design
This is a single-site, randomised, controlled, interventional pilot study. Thirty adults with idiopathic Parkinson's disease will be randomised in a 2:1 ratio to either Enhanced Tai Chi plus usual clinical care or usual clinical care alone. Assessments will be conducted at baseline, after completion of the 12-week intervention period, and at 3-month follow-up.
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
- Single (Outcomes Assessor)
盲法说明
Baseline and Outcome assessments are performed by a blinded rater who is not involved in intervention delivery and does not have access to group allocation. Participants and care providers are not masked due to the nature of the behavioural intervention.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's disease (Hoehn & Yahr stage I-III)
- •Able to stand and participate in movement sessions
- •Stable medication dose for ≥ 4 weeks before study entry
排除标准
- •Atypical or secondary parkinsonism
- •Advanced therapies (DBS, apomorphine infusion, jejunal levodopa)
- •Dementia (MoCA ≤ 21)
- •Other neurological or medical conditions limiting participation
- •Inability to commit to scheduled sessions
结局指标
主要结局
Change in motor symptoms (MDS-UPDRS Part III)
时间窗: Baseline to 12 weeks (end of intervention)
Clinician-rated assessment using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale, Part III (MDS-UPDRS III), performed in the ON medication state. Total score ranges from 0 to 132, with higher scores indicating greater motor impairment. Reductions in score indicate improvement in motor symptoms.
次要结局
- Change in apathy (Apathy Scale - AS)(Baseline, 12 weeks, 3-month follow-up)
- Change in physical activity level (PASE)(Baseline, 12 weeks, 3-month follow-up)
- Change in global clinical severity (CISI-PD)(Baseline, 12 weeks, 3-month follow-up)
- Change in balance performance (Berg Balance Scale)(Baseline, 12 weeks, 3-month follow-up)
- Change in mobility (Timed Up and Go - TUG)(Baseline, 12 weeks, 3-month follow-up)
- Number of monthly falls(Baseline, 12 weeks, 3-month follow-up)
- Feasibility / compliance with intervention(Continuous over 12-week intervention)
- Change in quality of life (PDQ-8)(Baseline, 12 weeks, and 3-month follow-up)
- Change in non-motor symptoms (MDS Non-Motor Symptoms Scale)(Baseline, 12 weeks, and 3-month follow-up)
- Patient Global Impression of Change (PGIC)(12 weeks and 3-month follow-up)
- Change in cognitive function (MoCA)(Baseline, 12 weeks, and 3-month follow-up)
- Change in pain (King's Parkinson's Disease Pain Scale - KPPS)(Baseline, 12 weeks, and 3-month follow-up)
- Change in sleep disturbance (PD Sleep Scale-2)(Baseline, 12 weeks, and 3-month follow-up)
- Change in fatigue (Parkinson's Fatigue Scale-16)(Baseline, 12 weeks, 3-month follow-up)
- Change in anxiety and depression (Hospital Anxiety and Depression Scale - HADS)(Baseline, 12 weeks, and 3-month follow-up)
- Change in physical activity level (PASE)(Baseline, 12 weeks, 3-month follow-up)
- Change in walking speed (10-Meter Walk Test)(Baseline, 12 weeks, 3-month follow-up)
- Number of monthly falls(Baseline, 12 weeks, 3-month follow-up)
- Change in apathy (Apathy Scale - AS)(Baseline, 12 weeks, 3-month follow-up)
- Change in global clinical severity (CISI-PD)(Baseline, 12 weeks, 3-month follow-up)
- Change in balance performance (Berg Balance Scale)(Baseline, 12 weeks, 3-month follow-up)
- Change in mobility (Timed Up and Go - TUG)(Baseline, 12 weeks, 3-month follow-up)
- Feasibility / compliance with intervention(Continuous over 12-week intervention)