Physical Training for People With Parkinson's Disease and Multiple Sclerosis: Effect on Mind and Body
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in anxiety and depressive symptoms
研究概览
简要总结
People with Parkinson's disease and Multiple Sclerosis experience disabling motor and non-motor symptoms, which respond insufficiently to medication. To adequately alleviate disease burden, physical training is increasing acknowledged as an assisting therapy; however, the optimal dose of exercise in unknown.
详细描述
Next to complex motor deficits, people with Parkinson's disease and Multiple Sclerosis experience highly disabling non-motor symptoms; for example, anxiety and depression, cognitive decline, fatigue, and sleep problems. Physical training is increasingly recognized as an assisting and, importantly, safe therapy for these patients to alleviate disease burden. However, the optimal dose (i.e., type, frequency, intensity, duration) of exercise has not yet been established. This study aims to investigate differences in response patterns of motor and non-motor symptoms, blood-based biomarkers of neuroplasticity and neurodegeneration, as well as functional brain connectivity to eight weeks of high intensity interval training [2x/week, ~30 min/session], continuous aerobic training [2x/week, ~50 min/session], or movement advice [+3000 steps/day for 5 days/week monitored with an activity tracker]. Frequently repeated assessment of outcomes measures will be conducted.
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)
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 Parkinson's Disease (PD) or Progressive Multiple Sclerosis (MS)
- •Hoehn & Yahr stage <4 (PD), Expanded Disability Status Scale score <6 (MS)
- •Anxiety and/or depressive symptoms; Hospital Anxiety and Depression Scale (HADS) score >=8 points on HADS-A and/or HADS-D
- •Sufficient cognitive ability to understand training instructions; Montreal Cognitive Assessment score >21 points
- •Able to participate in intensive physical training, no contra-indications for exercise
- •Stable medication regime for at least 4 weeks prior to inclusion
- •Age >=18 years
排除标准
- •Participation in intensive exercise program in the month prior to inclusion
- •Relapse in the month prior to inclusion (MS)
- •Symptoms indicating cardiovascular, pulmonary, or metabolic disease or cardiovascular, pulmonary, or metabolic disease which are not under control with medication
- •abnormal electrocardiography in rest
结局指标
主要结局
Change in anxiety and depressive symptoms
时间窗: Baseline (week 0), week 4, week 12, week 16
The effect of physical training on anxiety and depressive symptoms, measured by the Hospital Anxiety and Depression Scale
次要结局
- Change in daily sleep quality(Weekly assessment from baseline to week 16)
- Change in disease severity(Baseline (week 0), week 4, week 12, week 16)
- Change in cognitive function (i.e., ability to inhibit cognitive interference)(Baseline (week 0), week 4, week 12, week 16)
- Change in fatigue(Baseline (week 0), week 4, week 12, week 16)
- Change in well-being(Baseline (week 0), week 4, week 12, week 16)
- Change in motor capacity (i.e., finger dexterity)(Baseline (week 0), week 4, week 12, week 16)
- Change in biomarkers of neuroplasticity in blood(Baseline (week 0), week 4, week 12, week 16)
- Change in biomarkers of neurodegeneration in blood(Baseline (week 0), week 4, week 12, week 16)
- Change in structural brain connectivity(Week 4, week 12)
- Change in motor capacity (i.e., walking speed)(Baseline (week 0), week 4, week 12, week 16)
- Change in cognitive function (i.e., mental flexibility)(Baseline (week 0), week 4, week 12, week 16)
- Change in activities of daily living(Baseline (week 0), week 4, week 12, week 16)
- Change in brain morphology(Week 4, week 12)
- Change in brain iron concentration in the Substantia Nigra(Week 4, week 12)
- Change in brain neuromelanin content(Week 4, week 12)
- Change in cognitive function (i.e., range of cognitive operations: motor speed, attention, and visuoperceptual functions)(Baseline (week 0), week 4, week 12, week 16)
- Change in sleep quality(Baseline (week 0), week 4, week 12, week 16)
- Change in quality of life(Baseline (week 0), week 4, week 12, week 16)
- Change in motor capacity (i.e., lower extremity function, mobility, and fall risk)(Baseline (week 0), week 4, week 12, week 16)
- Change in brain connectivity(Week 4, week 12)
- Change in daily mood(Weekly assessment from baseline to week 16)
- Change in daily anxiety(Weekly assessment from baseline to week 16)
- Change in daily ability to concentrate(Weekly assessment from baseline to week 16)
- Change in daily fatigue(Weekly assessment from baseline to week 16)
研究者
Dr. Erwin E. H. van Wegen
Principal Investigator, Associate Professor Neurorehabilitation
Amsterdam UMC, location VUmc