Effects of Aerobic Exercise on Brain Health in People With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Percentage brain volume change
研究概览
简要总结
The purpose of the project is to investigate how aerobic exercise affects brain volume, specific brain regions, neurotrophins and cognition in patients with multiple sclerosis.
The study will be a single blinded randomized controlled trial with a 6 months intervention.
It is hypothesized that aerobic exercise can slow down brain atrophy, increase the size of hippocampus, upregulate the secretion of neurotrophins and improve cognitive performance in people with multiple sclerosis.
详细描述
Multiple Sclerosis (MS) is a physically and cognitively disabling, chronic autoimmune disease of unknown etiology. It is the most common neurological disease affecting young adults in Western countries. According to the Danish MS Registry the prevalence has increased markedly over the last 40 years for particularly women, and today there are approximately 14.000 patients with MS (PwMS) in Denmark.
The pathological hallmark of MS is sclerotic plaque. Plaques in the central nervous system (CNS) can be detected in vivo using magnetic resonance imaging (MRI). Both the accumulation of lesions and the accelerated whole-brain atrophy correlate with the progressing physical and cognitive disabilities that clinically characterize PwMS.
The disease causes damage of both white and grey matter in the CNS, leading to whole brain atrophy and topographically specific atrophy within the hippocampus and the frontal and temporal cortices. The degradation of the CNS manifests as cognitive and physical disability. Cognitive impairment is estimated to affect up to 65% of PwMS, making it one of the most common and disabling symptoms of MS. Medical therapies for cognitive impairment in MS have so far proved ineffective. Collectively, the prevalence, impact and missing treatments highlight the importance of alternative approaches towards preservation of cognitive function. Despite equivocal findings, aerobic exercise represents a promising approach towards preservation or even expansion of hippocampal volume and cognitive functioning in MS. No longitudinal randomized controlled trial (RCT) study has so far applied the MRI technique when evaluating the potential neuro-protective effect of exercise on brain structure and function in MS. Also, given the scarcity of effective treatments for cognitive impairment in MS, a longitudinal exercise intervention evaluating the potential effect of aerobic exercise on cognition is urgently needed in MS.
The purpose of the present project is to investigate how aerobic exercise affects brain volume, specific brain regions, neurotrophins and cognition in PwMS.
It is hypothesized that aerobic exercise can slow down brain atrophy, increase the size of hippocampus, upregulate the secretion of neurotrophins and improve cognitive performance in people with MS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed consent
- •Definite MS diagnosis
- •Be clarified with the diagnosis and treatment
- •Expectedly able to carry out the aerobic training / test
- •Expanded Disability Status Scale (EDSS) score ≤6.0
- •Must be able to transport themselves to and from training sessions
排除标准
- •Dementia, alcohol abuse or pacemaker
- •Medical comorbidity such as cardiovascular, respiratory, orthopedic or metabolic disorders or other concurrent diseases causing disability and hindering participation in the intervention
- •Disease relapse in a 8 week period prior to study start
- •Pregnancy
- •Metallic implants hindering the MRI scans.
- •Expected training attendance below 85%
结局指标
主要结局
Percentage brain volume change
时间窗: 0, 24 and 48 weeks
次要结局
- Cognition measured by the Brief Repeatable Battery of Neuropsychological Tests(0, 24 and 48 weeks)
- Blood samples: Cytokines and neurotrophins(0, 24 and 48 weeks)
- VO2max(0, 24 and 48 weeks)
- Regional volume change changes (e.g. hippocampus, thalamus)(0, 24 and 48 weeks)
- Modified Fatigue Impact Scale(0, 24 and 48 weeks)
- Fatigue Severity Scale(0, 24 and 48 weeks)
- Major Depression Inventory(0, 24 and 48 weeks)
- Short Form 36(0, 24 and 48 weeks)
- Multiple Sclerosis Impact Scale 29(0, 24 and 48 weeks)
- 6-min walk test(0, 24 and 48 weeks)
- Six Spot Step Test(0, 24 and 48 weeks)