Augmented Benefits of Different Exercise Types to Enhance Skill Learning in People With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- Change in gait performances
研究概览
简要总结
Background: Gait disturbance is one of the most common complaints from patients with Parkinson's disease (PD). It is well-established that people with PD have motor learning impairments. To enhance motor learning, several methods have been recommended, such as sleep, non-invasive brain stimulation techniques, and aerobic exercise. To date, only 2 studies have investigated the effects of acute aerobic exercise on motor learning in people with PD. It is yet unclear whether adding aerobic exercise after multiple motor training sessions can enhance motor learning in people with PD. Additionally, most prior evidences utilized moderate to high intensity aerobic exercise to facilitate motor learning, it is yet unclear whether other types of exercise (e.g., resistance training) could induce similar beneficial effects. Therefore, this proposed project is specifically designed to investigate the effects of adding aerobic or resistance exercise after motor training. To take a step further, this project will also determine the patient characteristics who may benefit from the intervention.
Objectives: (1) To examine whether adding specific exercise after training can facilitate learning on patients with Parkinson's disease. (2) To determine the characteristics of participants who may benefit from these types of intervention approach.
Methods: A total of 76 participants with idiopathic PD diagnosed by neurologists will be recruited. All eligible participants will be randomized into one of the 4 groups: aerobic group (AEX), resistance group (REX), conventional PT group (CPT), and control group (CON). All participants will receive 12 sessions of gait training. All outcome measures will be assessed before the intervention (pre-test), after the 6th intervention session (mid-test), after all 12 intervention sessions (post-test), and 1-month after the intervention (follow-up test). All assessments will be performed by an independent research assistant who will be blinded to the group allocation of the participants. The primary outcome will be gait performance, and the secondary outcomes will include measurements of cognitive and behavioral functions. Additionally, transcranial magnetic stimulation will be used to examine the changes of corticomotor excitability associated with the interventions.
详细描述
Background: Gait disturbance is one of the most common complaints from patients with Parkinson's disease (PD). It is well-established that due to the dysfunction of the corticostriatal circuits, people with PD have motor learning impairments and may consequently influence the effects of rehabilitation. To enhance motor learning, several methods have been recommended, such as sleep, non-invasive brain stimulation techniques, and aerobic exercise. To date, only 2 studies have investigated the effects of acute aerobic exercise on motor learning in people with PD. These 2 studies were cross-sectional studies that only provided a single bout of aerobic exercise and followed the effects on motor learning for 7 days. It is yet unclear whether adding aerobic exercise after goal-based motor skill training for multiple training sessions, like a regular clinical treatment regimen, can boost up the speed of motor skill acquisition and enhance retention and transfer performances for people with PD. Additionally, most prior evidences utilized moderate to high intensity aerobic exercise to facilitate motor learning, it is yet unclear whether other types of exercise (e.g., resistance training) could induce similar beneficial effects. To the best of our knowledge, no study is specifically designed to compare the addictive effect of aerobic or resistance exercise on motor skill learning in people with PD. Therefore, this proposed project is specifically designed to answer the above questions. To take a step further, this project will also determine the patient characteristics who may benefit from the intervention.
Objectives: (1) To examine whether adding aerobic or resistance exercise after walking skill training can facilitate learning of the walking task on patients with Parkinson's disease. (2) To determine the characteristics of participants who may benefit from these types of intervention approach.
The first aim of this study is to investigate investigate the effects of adding aerobic or resistance exercise after gait training in people with PD. The second aim is to further determine the characteristics of participants who benefit from the proposed training program..
Methods: A total of 76 participants with idiopathic PD diagnosed by neurologists will be recruited. All eligible participants will be randomized into one of the 4 groups: aerobic group (AEX), resistance group (REX), conventional PT group (CPT), and control group (CON). All participants will receive one-on-one intervention sessions with a trained physical therapist. Each intervention sessions will last 60 minutes, which will include 30 minutes of treadmill training and an additional therapy based on group allocation. The participants will come to the lab for 12 training sessions spread across 4 to 6 weeks. All outcome measures will be assessed before the intervention (pre-test), after the 6th intervention session (mid-test), after all 12 intervention sessions (post-test), and 1-month after the intervention (follow-up test). All assessments will be performed by an independent research assistant who will be blinded to the group allocation of the participants. The primary outcome will be gait performance, and the secondary outcomes will include Montreal Cognitive Assessment test, Stroop Color-Word test, Unified Parkinson's Disease Rating Scale, Fatigue Severity Scale, Activities-Specific Balance Confidence Scale, Parkinson's Disease Questionnaire-39, New Freezing of Gait Questionnaire, Geriatric Depression Scale, finger sequence task, Timed Up and Go test, 5 times sit to stand test. Transcranial magnetic stimulation will be used to examine the changes of corticomotor excitability associated with the interventions.
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
The researcher(s) who will conduct the outcome assessments will be masked from the group allocation.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's Disease
- •Able to follow instructions to perform the tasks
- •The Montreal Cognitive Assessment, MoCA ≥ 20
- •Be able to walk independently with or without devices for at least 10 meters
排除标准
- •Has deep brain stimulation or pacemaker implanted in their body
- •A self-history of seizure
- •A family-history of epilepsy
- •Pregnancy
- •Uncontrolled medical conditions
- •Unstable cardiovascular diseases
- •Has other neurological or psychological disorders in addition to Parkinson's Disease
研究组 & 干预措施
Aerobic exercise group (AEX)
Gait training followed by 20 minutes of moderate to high intensity aerobic exercise on a recumbent bicycle.
干预措施: Gait + aerobic exercise (Behavioral)
Resistance exercise group (REX)
Gait training followed by 20 minutes of resistance training targeting major muscle groups.
干预措施: Gait + resistance exercises (Behavioral)
Conventional physical therapy group (CPT)
Gait training followed by 20 minutes of conventional PT programs that do not involve aerobic or resistance exercise.
干预措施: Gait + conventional physical therapy (Behavioral)
Control group (CON)
Gait training followed by 20 minutes of rest (sitting on a chair and read magazines).
干预措施: Gait + rest (Behavioral)
结局指标
主要结局
Change in gait performances
时间窗: Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks)
The participants will be required to walk along a walkway with their comfortable walking speed, fastest walking speed and under dual task condition for 3 times each. The gait performances will be captured by the Physilog®5 system (Gait Up, Renens, Switzerland), which include two inertial sensors with built-in 3D accelerometers and gyroscopes.Gait performances in pretest, mid-test, post-test, and follow-up test will be evaluated, and the trend of changes will be determined.
次要结局
- Change in the Unified Parkinson's Disease Rating Scale (UPDRS)(Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks))
- Change in Parkinson's Disease Questionnaire-39 (PDQ-39)(Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks))
- Change in the Stroop Color-Word test(Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks))
- Change in fatigue severity questionnaire (FSS)(Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks))
- Change in muscle strength of lower extremity muscles(Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks))
- Change in Montreal Cognitive Assessment (MoCA)(Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks))
- Change in Activities-Specific Balance Confidence (ABC) Scale(Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks))
- Change in New Freezing of Gait Questionnaire (NFOG-Q)(Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks))
- Change in The Timed Up and Go (TUG) Test(Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks))
- Change in Five Times Sit-to-Stand (FTSTS) Test(Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks))
- Change in motor evoked potential (MEP)(Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks))
- Change in cortical silent period (CSP)(Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks))
- Change in intracortical inhibition and facilitation(Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks))
- Change in Geriatric Depression Scale (GDS)(Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks))
- Change in six-minute walk test (6MWT)(Four time points: pre-test (before intervention, 0 week), mid-test (after 6th intervention sessions, up to 2 weeks), post-test (after all intervention sessions, up to 4 weeks), follow-up test (one month after intervention, up to 8 weeks))