Effect of a 12-week Multimodal Exercise Intervention on Walking Economy, Fatigability, and Propulsion in Individuals With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Change in Walking Economy
研究概览
简要总结
Sustained ambulation is a challenge for individuals with Parkinson's disease (PD) as walking economy is frequently compromised. There are also various disease-related skeletal muscle alterations that may contribute to performance fatigability during ambulation. Concomitantly, individuals with PD experience substantial difficulty maintaining sustained forward progression at push-off during the gait cycle due to diminished force production. Exercise is commonly prescribed for these individuals, though traditional exercise approaches to PD have often applied a "one impairment-one modality" paradigm that addresses each impairment separately. Interventions to optimize movement should facilitate an individual's response to the challenge of responding to a complex interplay of constraints that are also specific to a task and its environmental context. Thus, there are multiple concurrent targets for exercise interventions that may not fit easily within a "one impairment-one modality" model. A multimodal intervention is designed to address an array of constraining impairments concurrently. However, the evidence-base for multimodal exercise approaches is still developing and far from conclusive.
The purpose of this study is to demonstrate that multimodal overground locomotion training (OLT) can promote walking economy during sustained overground ambulation in individuals with PD, and produce concurrent secondary effects that decrease performance fatigability and increase propulsion. The aims of this study are to 1) Evaluate walking economy during sustained overground walking after 12 weeks of multimodal OLT, 2) Evaluate secondary effects of OLT.
详细描述
Protocol Overview: Subjects will be recruited from the greater Washington D.C. metro area. Individuals interested in participating as subjects will complete initial verbal screening to determine eligibility for inclusion. Those subjects who volunteer to participate will then be consented and enrolled for participation if exclusion and inclusion criteria are met.
Visit 1: (~120 minutes) Subjects will fill out a medical history form. Height and weight measurements will then be taken. The Hoehn and Yahr, Mini-Mental State Exam, Fatigue Severity Scale (FSS), Physical Activity Readiness Questionnaire (PAR-Q), and Physical Activity Scale in the Elderly (PASE) will then be administered. Subjects will first perform the 10-meter walk test. Subjects will be asked by researchers to walk 10 meters across a pressure sensitive walkway, 5 times at both comfortable speed and fast speed. After the 10-meter walk test, subjects will be given a 10-20 minute resting period before the second test. Subjects performing the 10-minute walk test will be fitted with a portable metabolic unit consisting of a face mask and torso apparatus. Wearable sensors will be secured to both arms, trunk, and legs. Before the test, subjects will stand in a resting position for at least 3 minutes to gain resting metabolic data. The subjects will then be asked to walk as far as they (the subjects) can in 10 minutes. Following the 10-minute walking period, subjects will again stand in a resting position to obtain recovery data. Subjects will then be given a 10-20 minute resting period during the transition to the third test. For the third test, subjects will be fitted with reflective markers at pre-specified anatomical landmarks used in a standardized gait marker set, for example medial and lateral knee and ankle joints. Electromyography (EMG) sensors will be placed on lower limb muscles. Subjects will then be asked to walk at both their preferred and fast walking speed over a 6 meter platform with embedded force plates. Subjects will be asked to perform as many trials as necessary to collect sufficient force plate data. After this test, subjects will be given the opportunity for a rest period if required before ending the testing day. For those subjects who start with the gait propulsion test, the testing order will include the same procedures yet in the reversed order.
Visit 2: (~90 minutes) Researchers will measure adipose tissue thickness over the calf muscle on the more affected leg (as indicated by the subject) using standard calipers. Subjects will then undergo a vascular occlusion test while resting in a semi-recumbent position. To perform this test investigators will place a large blood pressure cuff on the thigh and will place a NIRS optode on the calf muscle. Investigators will then inflate the cuff to 220mmHg to occlude blood flow to the lower leg. After a 5 minute period of occlusion the cuff pressure will be released and recovery NIRS data will be obtained. Subjects will then perform the CWRT Subjects will be fitted with 12-lead ECG and ICG sensors, will wear a face mask to collect metabolic data, and will be asked to perform the CWRT. Before the CWRT, subjects will rest for a minimum of 2 minutes in a standing position on a treadmill. During the CWRT subjects will be asked to walk at a constant speed for 6 minutes and 30 minutes with an 8 minute rest period between bouts. After the CWRT subjects will be asked to rest in a standing position to obtain recovery data. After this test, subjects will be given the opportunity to rest for a period if required before ending the testing day.
Visits 3-26: (~1 hour each) For these visits, subjects will perform an overground multimodal locomotor training protocol. Subjects will train individually with 1-2 trained instructors. Subjects will wear a Polar chest strap and a research grade pedometer during each session to enable instructors to modify training within the session to maintain a target intensity zone. The training protocol covers 12 weeks with two sessions per week for a total of 24 sessions.
Visit 27 (~90 minutes): Subjects will repeat the same testing procedures as they did in visit 1 in the same order as they did, determined by the initial randomization process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •18 years of age or older
- •diagnosis of idiopathic Parkinson's Disease, mild to moderate (Hoehn and Yahr score less than or equal to 3)
- •speaks English
- •able to ambulate without requiring an assistive device
排除标准
- •neurological disease diagnosis other than PD
- •uncontrolled cardiovascular, pulmonary, neurological, or metabolic disease which may impact the ability to exercise or in which exercise is contraindicated
- •any medications, such as beta-blockers, that may alter HR or metabolic data
- •cognitive or psychiatric impairment precluding informed consent or ability to following instructions
- •mini-Mental State Examination score <24
- •pregnancy
结局指标
主要结局
Change in Walking Economy
时间窗: pre and post 12 week intervention protocol
measured as oxygen consumption (VO2) over distance walked (meters) during a 10-minute walk test
次要结局
- Change in Performance Fatigability(pre and post 12 week intervention protocol)
- Change in Propulsion(pre and post 12 week intervention protocol)
- Change in Spatiotemporal Parameters during Overground Walking(pre and post 12 week intervention protocol)
- Change in Resting Skeletal Muscle Oxygenation and Hemodynamics(pre and post 12 week intervention protocol)
- Change in Interlimb Coordination(pre and post 12 week intervention protocol)
- Change in Cardiorespiratory Response to Treadmill Walking(pre and post 12 week intervention protocol)
- Change in Muscle Activation(pre and post 12 week intervention protocol)
- Change in Perceived Fatigability(pre and post 12 week intervention protocol)
- Change in Self-Reported Exertion During Treadmill Walking(pre and post 12 week intervention protocol)