Neuroprotective, Motor and Cognitive Impact of a Long-standing Aerobic Training Program in Parkinson's Disease. A Multicenter Comparison of the Effects of Two Aerobic Programs of Graded Intensities and a Conventional Physical Therapy Program Prolonged for 9 Months on Nigrostriatal, Motor and Cognitive Functions.
试验速览
- 阶段
- 不适用
- 入组人数
- 69
- 试验地点
- 6
- 主要终点
- Change in MDS-UPDRS III Score (Movement Disorders Society - Unified Parkinson's Disease Rating Scale) in the " OFF " state between Day 1 and Month 9.
研究概览
简要总结
In phenotypic animal models of Parkinson's Disease (PD), chronic physical exercise has produced nigrostriatal neuroprotection and symptom improvement, provided training was of high-intensity and prolonged duration (>3 months in rodent models). Conventional physical therapy in Parkinson's disease (PD) has traditionally avoided fatigue and high intensity workouts. Yet, in PD controlled studies have shown that: (i) an acute aerobic stress produces endogenous dopamine immediately after the exercise and (ii) short term (a few weeks) high intensity aerobic training enhances D2 striatal receptor density and cortical excitability and clinically improves walking, upper limb and executive functions; (iii) long-term (six months) high intensity aerobic treadmill training is associated with less deterioration of subjective UPDRS III score compared to a waiting list. Long-term high intensity aerobic training has not been compared to low or medium intensity training in PD patients for its objective motor, cognitive and putative neuroprotective effects.
详细描述
A short description, 5000 characters Intro: In phenotypic animal models of Parkinson's Disease (PD), chronic physical exercise has produced nigrostriatal neuroprotection and symptom improvement, provided training was of high-intensity and prolonged duration (>3 months in rodent models). Conventional physical therapy in Parkinson's disease (PD) has traditionally avoided fatigue and high intensity workouts. Yet, in PD controlled studies have shown that: (i) an acute aerobic stress produces endogenous dopamine immediately after the exercise and (ii) short term (a few weeks) high intensity aerobic training enhances D2 striatal receptor density and cortical excitability and clinically improves walking, upper limb and executive functions; (iii) long-term (six months) high intensity aerobic treadmill training is associated with less deterioration of subjective UPDRS III score compared to a waiting list. Long-term high intensity aerobic training has not been compared to low or medium intensity training in PD patients for its objective motor, cognitive and putative neuroprotective effects.
Hypothesis/Objective
Hypothesis High-intensity aerobic exercises practiced over 9 months will produce greater symptomatic motor and cognitive benefits and neuroprotective effects in PD patients, than low or medium intensity training.
Primary Objective To compare the motor effects of a 9-month conventional physical therapy program (light aerobic exercises), an aerobic program of medium intensity on stationary bicycle (50% maximal oxygen uptake, VO2 max), and an aerobic program of high intensity (70% VO2 max) in Parkinson's disease.
Secondary Objectives
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
- Double (Investigator, Outcomes Assessor)
盲法说明
- Study participants will be unaware of the hypothesis.
- All investigator assessors, clinical, cardiological, biomechanical or through SPECT [123I] beta-CIT striatal uptake measurements, will be unaware of the participant group
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 PD according to the UKPDSBB criteria
- •Previous MRI available, to further help distinguish idiopathic PD from atypical parkinsonism Hoehn & Yahr Stage 1-3 in OFF state
- •Age > 18
- •Signed informed consent to participate in study
排除标准
- •Patients lacking motivation or ability to participate in training sessions for 9 months, in the investigator's opinion
- •Contra-indications to high-intensity aerobic training in the cardiologist's opinion
- •Contra-indications to perchlorate de potassium or to the use of 123I-FP-CIT
- •Concurrent severe co-morbidities
- •Cognitive deficit limiting participation to the program in the investigator's opinion
- •Montreal Cognitive Assessment test (MoCA)<23
- •Uninsured patient
- •Participation in another ongoing interventional clinical trial (drug therapy, surgical treatment, another rehabilitation treatment, medical device)
- •Pregnancy or current lactation, or no efficacious contraception during the 9 months of intervention.
结局指标
主要结局
Change in MDS-UPDRS III Score (Movement Disorders Society - Unified Parkinson's Disease Rating Scale) in the " OFF " state between Day 1 and Month 9.
时间窗: at day 1 and 9 Months
The MDS-UPDRS III Score is a subjective assessment of motor symptoms based on the addition of ordinal 1-4 scores.
次要结局
- Two-minute walking test at maximal speed(at day 1, 9 Months and 12 Months)
- Maximal aerobic capacity (VO2 max)(at day 1, 9 Months and 12 Months)
- Montreal Cognitive Assessment test (MoCA)(at day 1, 9 Months and 12 Months)
- Modified 20-meter up-and-go test (AT20)(at day 1, 9 Months and 12 Months)
- Global Mobility Task (GMT)(at day 1, 9 Months and 12 Months)
- Trail Making Test(at day 1, 9 Months and 12 Months)
- Upper limb performance in activities of daily living (Mount Sinai Parkinsonism Impairment Rating Scale, MSPIR)(at day 1, 9 Months and 12 Months)
- Digit span task (forward and backward)(at day 1, 9 Months and 12 Months)