Effectiveness of a HIFT Training Program on Cognitive and Functional Performance in People With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Barthel index
研究概览
简要总结
Parkinson's disease (PD) is a progressive and chronic neurodegenerative disease, which presents signs and symptoms both motor (impaired gait, posture, balance, etc.) and cognitive (memory loss, dementia, etc.), all of which cause disability and assuming a high economic cost. Currently, there are already certain authors who have shown how a high-intensity interval training (HIIT) protocol produces improvements in cognitive and physical performance in healthy adults and in people with multiple sclerosis. However, another modality has been created, such as high-intensity functional training (HIFT), which can benefit different populations, both healthy and pathological, due to the multimodal nature of the exercises. These are prescribed knowing the target group and involve the whole body using universal motor recruitment patterns in multiple planes of movement such as squats. The main hypothesis of the study is that high-intensity functional training (HIFT), at a motor and cognitive level, provides a greater benefit than conventional programs of strength, balance and cognition, on the functionality and cognitive capacity of people with Parkinson's disease.
详细描述
Parkinson's disease (PD) is a progressive and chronic neurodegenerative disease, which presents signs and symptoms both motor (impaired gait, posture, balance, etc.) and cognitive (memory loss, dementia, etc.), all of which are causing disability and assuming a high economic cost.
This pathology is characterized by the destruction, due to still unknown causes, of the dopaminergic neurons, which are found in a region of the brain called the basal ganglia, specifically in a part of the brainstem called the substantia nigra. These neurons act in the central nervous system and use dopamine as their primary neurotransmitter, responsible for transmitting the necessary information for the correct control of movements. For this reason, the result of its destruction involves slowing of movements along with lack of coordination.
These processes cause multiple deficits in higher cortical functions, affecting the motor and cognitive capacity of the individual and, therefore, negatively affecting the execution of both basic and instrumental daily activities.
PD is the second most common neurodegenerative disease after Alzheimer's and it presents in both sexes in a similar way, with a slight predominance in men. The World Health Organization already estimated in 2005 a global incidence of 4.5-19 new cases per year per 100,000 inhabitants and a global prevalence of 100-200 cases per 100,000 inhabitants, while a more recent report published by the European Parkinson's Disease Association estimates a worldwide prevalence for the year 2030 of between 8.7 and 9.3 million people. 70% of patients are people over 65 years of age, and 15% of all those affected are adults under 45 years of age. As a general rule, PD affects 1% of the population over 60 years of age, 2% of those over 70 years of age, and 3% of those over 803.
Due to all the physical and psychological consequences that can occur, the economic impact of this type of neurodegenerative pathology in the family nucleus is really great. The average annual expenditure per family unit for the different neurological pathologies is 13,063 euros. If the investigators focus on the EP, the amount is established up to the figure of 9,219 euros per year. This expense is usually progressive according to the degree of advancement of the disease, averaging an expense of 7,146 euros in the incipient phase of the disease, going through 8,491 euros in the intermediate phase and reaching 14,443 euros in the advanced phase. From all this it can be deduced that families are currently the main providers of support services for this type of patient, causing a very high cost for them. In this sense, it is important to highlight that a large percentage of patients have had to change their address or have had to carry out reforms to adapt the home to their situation (bathroom, adjustable bed, crane, restraints or barriers for the bed, among others).
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
Randomization will be performed using an Excel spreadsheet, following random number filters.
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's disease.
- •Phase I or II (Hoehn - Yahr Scale).
- •Independent ambulation for 10 consecutive minutes.
- •Perform physical exercise on a regular basis.
排除标准
- •Medical contraindication for physical activity, deafness or limited hearing and very low vision or blind.
- •Vestibular disorders that compromise balance.
- •Serious psychotic or cognitive disorder.
- •Decompensation or changes in medication.
- •Surgical intervention in the last 6 months.
- •Sedentary people
研究组 & 干预措施
Control group
The control group followed their routine of both physical and cognitive exercises that were recorded for their control. Balance exercises, strength and aerobic exercise. They were assessed at the beginning and at the end of the 10 weeks.
干预措施: Hight intensity functional trainning (Other)
HIFT group
High-intensity functional training was carried out for 10 weeks. The rehabilitation pillar was based on high-intensity functional training. 45-minute sessions divided into 5 minutes of warm-up, 35 minutes of functional exercises, and 5 minutes of going back to bed and cooling down. The 35 minutes of exercises were divided into 3 categories: lower extremity exercises, upper extremity exercises, and static and dynamic balance and coordination exercises. Each category consists of 3 exercises per session, performing 2 sets with a maximum of 10-RM repetitions. Load progression was progressively increased at weeks 3, 5, and 8 between 40-60% of the 1-RM.
干预措施: Hight intensity functional trainning (Other)
结局指标
主要结局
Barthel index
时间窗: At week 0 and 11
It was first described by Mahoney and Barthel in 1965 and is widely used by clinicians and researchers. The BI is defined as a generic measure that assesses the patient's level of independence with respect to performing some activities of daily living (ADL), through which different scores and weights are assigned according to the ability of the examined subject to carry out carry out these activities. The values assigned to each activity are based on the time and amount of physical assistance required if the patient is unable to perform that activity. It is made up of ten basic activities that include feeding, dressing and undressing, washing, using the toilet, urination control, stool control, transfers, use of personal hygiene, going up and down stairs and walking. The scores range from 0 to 10 points, passing through 5. 0 is totally dependent on the third person, 5 means that he needs some help and 10 is totally independent.
Fall Risk Assessment Score Scale
时间窗: At week 0 and 11
The Fall Risk Assessment Score Scale is a tool that was developed to predict the risk of falls in older people. It is based on five questions about the last year: history of falls in the last 12 months (2 points); decreased gait or noticeable changes in it (1.5 points); loss of balance in the last 12 months (1 point); visual deficit (1 point); decreased grip strength in the hands (1 point). Each variable is associated with a different score, indicated in parentheses at the end of each item. The final score of the scale varies between 0 and 6.5, in such a way that the higher the score, the greater the probability of suffering a fall. Thus, the cut-off value for this scale is 3.5 points, by which scores higher than this are considered to imply risk of falls.
2 minute walk test (2-MWT)
时间窗: At week 0 and 11
The 2-MWT15 is a simple, inexpensive, and easy-to-administer test that consists of measuring the maximum distance that the patient is able to walk in 2 minutes, in a short walk in a corridor, simultaneously evaluating the heart rate, the saturation of oxygen and the degree of dyspnea using the Borg scale. Its physiological basis is that the distance achieved on a flat course during the defined time (2 minutes) is an expression of the individual's capacity for submaximal exercise, which allows an evaluation of this capacity in different respiratory pathologies. The 2-MWT influences, in addition to an underlying cardio-respiratory pathology, motivational and musculoskeletal factors that provide a global assessment of exercise capacity and can reflect the daily activity of patients better than other laboratory tests.
Mini Mental State Examination
时间窗: At week 0 and 11
It is a brief test that assesses cognitive function. The questions included in the test attempt to examine various areas of cognitive function: orientation, registration, concentration, memory, language, and copying a figure. The Mini Mental State Examination total score is widely accepted as an indicator of the severity of cognitive impairment. Sensitivity is 87% and specificity is 82% in detecting dementia. Likewise, the values obtained in test-retest, 0.89, and from the inter-rater, 0.82, have also shown that Mini Mental State Examination is an effective instrument in the English language. Concurrent validity has been tested with extensive neuropsychological tests and also in longitudinal studies. The test has been widely used in clinical practice and in research.
Trail Making Test A y B
时间窗: At week 0 and 11.
The test with part A and B measures visual search, scanning, processing speed, mental flexibility and executive functions. In Part A, the subject uses a pencil to connect a series of 25 circled numbers in numerical order on a sheet of paper with the prompt to do so in the shortest time possible. This makes it possible to accurately measure search tools and visual attention and psychomotor speed. In part B, a similar execution is required, with the exception that the person must alternate the sequence of numbers from 1 to 13 with letters from "A" to "L". In this way, we can obtain data on executive control, cognitive flexibility and alternation. The evaluated person is timed, obtaining the resulting time. If the examiner notices an error in the order of the lines drawn, she must interrupt the subject and correct the error without stopping the stopwatch during the correction.
Sociodemographic and neurological data registration form
时间窗: At week 0
Form for registering clinical history, sociodemographic data and neurological history of each participant, as well as personal and contact information.
Barthel index
时间窗: At week 0 and 11
It was first described by Mahoney and Barthel in 1965 and is widely used by clinicians and researchers. The BI is defined as a generic measure that assesses the patient's level of independence with respect to performing some activities of daily living (ADL), through which different scores and weights are assigned according to the ability of the examined subject to carry out carry out these activities. The values assigned to each activity are based on the time and amount of physical assistance required if the patient is unable to perform that activity. It is made up of ten basic activities that include feeding, dressing and undressing, washing, using the toilet, urination control, stool control, transfers, use of personal hygiene, going up and down stairs and walking. The scores range from 0 to 10 points, passing through 5. 0 is totally dependent on the third person, 5 means that he needs some help and 10 is totally independent.
Short physical performance battery (SSPB)
时间窗: At week 0 and 11
The test includes 3 spheres as described below: 1. Balance test A. Stand with feet together side by side B. Semi-tandem C. Full tandem 2. Walking speed test: Walk 4 meters and record the time. 3. Chair rise test: Sit down and get up from the chair 5 times and record the time spent. Each test is scored from 0 to 4. The total score ranges from 0 to 12 points.
Fall Risk Assessment Score Scale
时间窗: At week 0 and 11
The Fall Risk Assessment Score Scale is a tool that was developed to predict the risk of falls in older people. It is based on five questions about the last year: history of falls in the last 12 months (2 points); decreased gait or noticeable changes in it (1.5 points); loss of balance in the last 12 months (1 point); visual deficit (1 point); decreased grip strength in the hands (1 point). Each variable is associated with a different score, indicated in parentheses at the end of each item. The final score of the scale varies between 0 and 6.5, in such a way that the higher the score, the greater the probability of suffering a fall. Thus, the cut-off value for this scale is 3.5 points, by which scores higher than this are considered to imply risk of falls.
Trail Making Test A y B
时间窗: At week 0 and 11.
The test with part A and B measures visual search, scanning, processing speed, mental flexibility and executive functions. In Part A, the subject uses a pencil to connect a series of 25 circled numbers in numerical order on a sheet of paper with the prompt to do so in the shortest time possible. This makes it possible to accurately measure search tools and visual attention and psychomotor speed. In part B, a similar execution is required, with the exception that the person must alternate the sequence of numbers from 1 to 13 with letters from "A" to "L". In this way, we can obtain data on executive control, cognitive flexibility and alternation. The evaluated person is timed, obtaining the resulting time. If the examiner notices an error in the order of the lines drawn, she must interrupt the subject and correct the error without stopping the stopwatch during the correction.
Short Form 12-item Questionnaire
时间窗: At week 0 and 11
Short Form 12-item Questionnaire is a generic health-related quality of life measurement instrument. It was born as an abbreviated version of the Short Form 36-item Questionnaire, since it consists of 12 items compared to the 36 items of the original and its administration time is approximately 2 minutes. The measurement is based on a Likert-type dichotomous scale, with a different number of response categories, between three and six. The scores of the twelve items were standardized to later place them in a range between 0 and 100. The objective is to evaluate the degree of well-being and functional capacity of people over 14 years of age. This test includes 2 dimensions that represent 8 health concepts most frequently used when measuring quality of life, as well as aspects related to illness. The higher the score, the healthier the person is.
2 minute walk test (2-MWT)
时间窗: At week 0 and 11
The 2-MWT15 is a simple, inexpensive, and easy-to-administer test that consists of measuring the maximum distance that the patient is able to walk in 2 minutes, in a short walk in a corridor, simultaneously evaluating the heart rate, the saturation of oxygen and the degree of dyspnea using the Borg scale. Its physiological basis is that the distance achieved on a flat course during the defined time (2 minutes) is an expression of the individual's capacity for submaximal exercise, which allows an evaluation of this capacity in different respiratory pathologies. The 2-MWT influences, in addition to an underlying cardio-respiratory pathology, motivational and musculoskeletal factors that provide a global assessment of exercise capacity and can reflect the daily activity of patients better than other laboratory tests.
Borg scale
时间窗: For 10 weeks
It is a standardized and validated visual analog scale in Spanish, quick and easy to apply, which allows graphically evaluating the subjective perception of respiratory distress or physical effort exerted. The Borg scale has been used since the 1970s and the modified one since the 1980s, which has a range from 0 to 10. The scale determines the intensity of dyspnea and has a written expression added to the number, which helps to categorize the sensation of dyspnea of the subject to whom the test is performed. The result is recorded and coded. The interval between the ranges of the scale increases progressively, number 10 shows the greatest perception of dyspnea (of effort). The modified Borg scale is easy to use if the patient is properly instructed.
Mini Mental State Examination
时间窗: At week 0 and 11
It is a brief test that assesses cognitive function. The questions included in the test attempt to examine various areas of cognitive function: orientation, registration, concentration, memory, language, and copying a figure. The Mini Mental State Examination total score is widely accepted as an indicator of the severity of cognitive impairment. Sensitivity is 87% and specificity is 82% in detecting dementia. Likewise, the values obtained in test-retest, 0.89, and from the inter-rater, 0.82, have also shown that Mini Mental State Examination is an effective instrument in the English language. Concurrent validity has been tested with extensive neuropsychological tests and also in longitudinal studies. The test has been widely used in clinical practice and in research.
次要结局
未报告次要终点
研究者
Marta Aguilar
Assistant Professor
University of Valencia