The Improvement in Cognitive and Motor Function: An 8 Week Study Comparing the Effects of Instability Resistance Training Versus Aerobic Training on Cognitive and Motor Improvements Found in Parkinson's Disease Participants.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- gait variability
研究概览
简要总结
This study will be looking at the effects that instability resistance training and aerobic training, individually, have on the improvement of various motor and cognitive impairments present in individuals with Parkinson' disease.
There will be 25-30 participants in this study (all of whom have Parkinson's disease). Once passing the eligibility criteria, participants will complete as series of baseline/pre-tests and then be randomly assigned to either the aerobic training group or the instability training group, where they will participate in every training session that occurs in the next 8 consecutive weeks. There will be 3 training sessions a week occurring on non-consecutive days (ex. Monday, Wednesday, Friday) for both training groups (3 aerobic training sessions, 3 instability resistance training sessions). Once the 8 week training intervention has been completed, a series of post-tests will occur exactly once week after (same tests used as in the pre-tests)
详细描述
Twenty-eight to thirty selected participants that fit the eligibility criteria will go through a series of baseline (pre-test) tests during screening session. It should be noted that all participants are to be assessed in their clinical "ON" state (fully medicated).Motor and cognitive tests are conducted to determine the baseline level of participants in the following domain of motor and cognitive functions:
- Timed Up and Go test: mobility test measuring participants static and dynamic balance on gait mat (Protokinetic gait mat)
- Protokinetic gait mat: measure gait velocity and spatial and temporal gait variability (stride length, stride time, double support time, and step width)
a.Measured through three tests: i.dual-tasking walking (counting backwards from 15, naming countries) ii.walking at normal speed (3 trails) iii.fast walking 3. Grip Strength test: measure overall strength 4. Unified Parkinson's Disease Rating Scale (UPDRS): assess various motor, cognitive, emotional and activities of daily living components of Parkinson's disease 5. Montreal Cognitive Assessment (MoCa) test: assess cognitive domains and look for Mild Cognitive Impairment (MCI) (attention and concentration, executive functions, memory, language) with scores ranging from 13-24 6. Trail-Making Test: tests visual attention and task-switching Part A: includes number 1-25, must draw lines and connect numbers in ascending order Part B: includes both letters and numbers; must draw lines connecting number and letters in ascending order ( but must alternate between number and letters, ex. 1-A-2-B) 7. Delis-Kaplan Executive Function System: executive function deficits, those being: measurement of selective attention and cognitive flexibility Trial 1: participant would say out loud the patches of colour Trial 2: participant would read words out loud printed in black ink Trial 3: participant has to say the ink colour, not the word Trial 4: participant has to say the ink colour, not the word UNLESS the word is in a box, then the participant has to say the word and not say the ink colour. 8. Parkinson Disease Cognitive Rating Scale : comprehensive cognitive function scale (measuring frontal sub-cortical and posterior cortical tasks)
Intervention Once baseline tests are completed, participants will be randomly assigned into either the instability resistance training group or the aerobic training group (done through RANDOM.org database), with each group receiving equal number of participants. Participants will participate in an eight week training program that will begin within one week after the baseline tests are completed. This training program will run over the course of eight weeks, with scheduled training sessions occurring three times a week (Monday, Wednesday, Friday), and will be running for one hour for both AET and IRT training groups. In total, there will be a total of twenty-four training sessions for both AET and IRT groups.
Aerobic Training
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
盲法说明
Investigator will not engage in the 8 week training program occurring, a leading supervisor will lead every training session so that the primary investigator (myself) will be blinded to the participants and their performance throughout the 8 week training interventions.
Participants from the opposite training groups will have separate training session times. In this way, no participant from the opposite training group will have contact with each other (ex. aerobic training group's session is at 12pm; instability resistance training group's session is at 4pm).
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson's disease participants aged between 50 to 80 years old
- •Has idiopathic Parkinson's disease
- •On stable medication (dopaminergic medication)
- •Hoehn and Yahr stage between 2 and 3
- •Does not present other neurological disorder other than Parkinson's disease)
- •Does not have significant arthritis, cardiovascular disease, and cognitive impairment by Mini-Mental State Examination (score <23)
- •Has normal or corrected vision in at one eye in order to carry out exercise)
- •Able to comply to scheduled visits, treatments, and other trial procedures
- •Must be in sufficient health to participate in study's training program as determined through the use of Physical Activity Readiness Questionnaire-Plus (PARQ+) screening tool, coupled with evaluation by a certified exercise physiologist/physician for clearance to participate in training program
排除标准
- •has uncontrolled hypertension and/or diabetes
- •Is currently participating in any form of physical activity/exercise program that involves AET or RT two or more times a week in the last six months
- •presence of dementia which is determined by having a score of 13 or less on the MoCa test.
- •has significant arthritis, cardiovascular disease, and cognitive impairment by Mini-Mental State Examination (score <23)
研究组 & 干预措施
Aerobic training group (AET)
Each AET sessions are to last one hour, with 40 minutes being allocated to the aerobic exercise training component, 10 minutes allocated to warm-ups, 5 minutes allocated to cool-downs, and one 5 minute rest period between the 20 minutes spent on each machine (20 minutes of cycling, 5 minute rest, 20 minutes seated row). The AET program consists of 20 minutes of cycling on the stationary bicycle and 20 minutes of seated row on the kinesis Technogym machine. This is to be preceded by 10 minutes of static stretching during warm up, and 5 minutes of post-exercise recovery (dynamic stretches).
干预措施: Exercise (Other)
Instability training group (IRT)
Each IRT sessions are to last one hour, with time being allocated to a 10 minute warm up, consisting of static stretches, a 5 minute cool down, consisting of dynamic stretches, and a series of IRT exercises performed in a circuit setting over the duration of 40 minutes. In the sessions, five resistance exercises will be performed. A linear periodization will occur, in which the training load will progress from high-volume low-intensity to low-volume high-intensity loads over the duration of eight weeks to maximize training adaptations. Additionally, there will be a progressive increase in load/resistance by 1-2 lbs and the degree of instability of each exercise during the course of the eight week program. Unstable devices will be changed from the least unstable to the most unstable device throughout the program, but only when participants showed a considerable decrease in body sway/movement and force production increased when performing exercises.
干预措施: Exercise (Other)
结局指标
主要结局
gait variability
时间窗: change from baseline gait functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
gait variability will be measured using the the Protokinetic Gait-walk test
gait (static and dynamic balance)
时间窗: change from baseline gait functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
static and dynamic balance will be measured using Timed Up and Go Test
executive function (visual attention and task switching)
时间窗: change from baseline executive functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
visual attention and task switching ability will be measured using the Trail Making Test
executive function (attention, working memory and recall verbal memory)
时间窗: change from baseline executive functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
sustained attention, working memory, and immediate and delayed free recall verbal memory is measured using the Parkinson's Disease Cognitive Rating Scale (score total out of 134-the perfect score. The closer to 134, the the better results)
executive function (memory, language and concentration)
时间窗: change from baseline executive functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
memory, language and concentration will be measured using Montreal Cognitive Assessment test
executive function (selective attention, cognitive flexibility)
时间窗: change from baseline executive functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
selective attention, cognitive flexibility will be measured using the Delis-Kaplan Executive Function System test
muscular strength
时间窗: change from baseline muscular strength tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
muscular strength will be measured using the grip strength test (jamar dynamometer tool)
assessing comprehensive motor and non-motor symptoms
时间窗: change from baseline motor and non-motor functions tested after 8 weeks of intervention (post-test measured on consecutive week after last week of intervention)
assess non-motor experiences of daily living, motor experiences of daily living, motor examination, and motor complications symptoms will be assessed through the Unified Parkinson's Disease Rating Scale (0-4 rating scale, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe)
次要结局
未报告次要终点
研究者
Alisha Mistry
Primary Investigator
Sun Life Financial Movement Disorders Research and Rehabilitation Centre