Effects of the HiBalance-program: Linking Clinical Signs and Symptoms to Changes in the Brain in People With Parkinson´s Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Mini-BESTest
研究概览
简要总结
This project aims to determine the effects of the HiBalance program on neuroplastic changes in people with mild to moderate Parkinson´s disease. The main hypothesis is that highly challenging exercise will lead to greater gait and balance ability, increased levels of physical activity and an improved health related quality of life. The investigators further hypothesize that neuroplasticity changes will be seen in corresponding areas of the brain, neuropsychological changes on cognitive test measures, and that exercise will inhibit the degeneration of dopaminergic neurons in the brain through the mediation of neurotrophic factors.
详细描述
Parkinson's disease (PD) is a neurodegenerative disease affecting many physiological systems essential for balance control. New findings suggest that intensive, challenging and cognitively demanding exercises could induce neuroplasticity in PD. A new balance training (the HiBalance program) have therefore been developed; emphasizing critical aspects of balance control through highly challenging and progressive exercises incorporating dual/multi-tasking (Conradsson et al, 2012). In an RCT, the HiBalance-program was shown to improve balance, gait and physical activity level in favor for the training group (Conradsson et al, 2015). In this proposal the investigators will combine physiotherapy, neurology and neuroimaging to characterise and determine the effects on physical and cognitive symptoms as well as structural and functional changes and wet biomarkers in the brain after the training.
Participants will be recruited through Karolinska University Hospital and via announcements in relevant forums like for instance the Swedish Parkinson Association. According to earlier power calculations for detecting effects in balance and gait measures after this particular intervention, the investigators anticipate 40 to 50 participants in each group to detect significant changes.
The investigators will perform both per protocol analysis and intention to treat analysis using mixed model or repeated measurement ANOVAs if the data is normally distributed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Investigator and outcome assessors are masked to group allocation at baseline assessment. Care providers are masked to results of the assessments.
Participants are masked to the studied intervention/treatment.
入排标准
- 年龄范围
- 60 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
- •Hoehn & Yahr 2-3
- •≥ 60 years of age
- •Be able to ambulate indoors without mobility aid
- •Balance impairment
排除标准
- •=< 21 points on MoCA
- •Other medical conditions that could substantially influence balance performance, voice or speech performance or participation in the interventions
- •Participating in an intensive exercise program for balance or speech during the last six months.
- •Additional exclusion criteria for the brain imaging will include the presence of; pacemakers, deep brain stimulators or other MRI incompatible implants, claustrophobia, inability to hear instructions without hearing aid, unilateral or bilateral blindness, severe diplopia, tremor, dyskinesia or dystonia.
研究组 & 干预措施
HiBalance
The HiBalance program is based on scientifically well-established principles of exercise training and postural control as well as current research on training in PD. The training will be conducted as a progressive individually adjusted group program in order to challenge the specific balance disorder of every participant and endorse progression. The intervention will be performed for an hour, 2 times/week in groups of six to eight participants for a total of 10 weeks and one home training session on their own.
干预措施: HiBalance (Behavioral)
Speech therapy
The control group will receive a group treatment (2 times/w for 10 w + 1 home training session) consisting of speech and communication therapy performed by a speech therapist. This intervention will be performed in a sitting position. The speech and communication treatment will aim at increasing vocal loudness and improving articulatory precision. Level of difficulty is gradually increased by progressing from using loud voice and clear speech in short and automatized utterances, to using the same technique in more complex sentences and situations. The group format is used to practice techniques in communicative situations and also to introduce increasing level of multitasking by combining speech training with cognitively more challenging tasks in the group training.
干预措施: Speech and communication therapy (Behavioral)
结局指标
主要结局
Mini-BESTest
时间窗: Pre intervention baseline and post intervention at 10 weeks
Mini-Balance Evaluation Systems Test a rating scale for dynamic balance incorporating 14 different balance and gait items that were assessed by a physical therapist on a scale from 0-2. Maximum points 28. 0-28 points with higher scores indicating better balance control
次要结局
- Gait Parameters(Pre intervention baseline and post intervention at 10 weeks)
- Neuropsychological Tests(Pre intervention baseline and post intervention at 10 weeks)
- Quality of Life Questionnaires(Pre intervention baseline and post intervention at 10 weeks)
- Movement Disorder Society - Unified Parkinsons Disease Rating Scale (MDS-UPDRS)(Pre intervention baseline and post intervention at 10 weeks)
- Physical Activity Measured With Accelerometers(Pre intervention baseline and post intervention at 10 weeks)
- Structural Magnetic Resonance Imaging(Pre intervention baseline and post intervention at 10 weeks)
- Task-induced Brain Activity as Measured by Functional Magnetic Resonance Imaging(Pre intervention baseline and post intervention at 10 weeks)
- Wet Biomarkers(Pre intervention baseline and post intervention at 10 weeks)
研究者
Erika Franzén
Associate Professor
Karolinska Institutet