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临床试验/NCT05482776
NCT05482776已完成不适用

Effectiveness of a HIFT Program on Cognitive and Functional Performance in People With Parkinson's Disease: Randomised Pilot Trial

University of Valencia1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2022年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
1
主要终点
Recruitment rate

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 primary neurotransmitter, responsible for transmitting the necessary information for the correct control of movements. For this reason, the result of 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. On the PD, 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).

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. These training programs are of a unimodal nature, that is, specific exercises for a specific joint and muscle group such as jumping, rowing, running or lifting weights, among others. 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. Thanks to multimodality, more aspects such as agility, coordination and precision of movements are worked on compared to unimodal HIIT programs that make this relevant work difficult in a person's daily life. However, the functionality of the exercises provides added value, since it improves the motivational factor, which in turn increases adherence to the program and the obtaining of health benefits. The current study aims to demonstrate the effectiveness of a HIFT training protocol in a specific population, such as people with Parkinson's disease.

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)

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

classic training group

Active Comparator

The classic training 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: classic training group (Other)

HIFT group

Experimental

The experimental group performed 10-weeks training program consisted in Warm-up phase and HIFT training. They were assessed at the beginning and at the end of the 10 weeks.

干预措施: High intensity functional training (Other)

结局指标

主要结局

Recruitment rate

时间窗: Baseline

Proportion of randomized participants relative to the number of screened participants. Feasibility criteria \> 75 %

Trial completion rate

时间窗: 11 weeks

Proportion of randomized participants who complete the trial. Feasibility criteria \> 80 %

Assessment test performance ratio

时间窗: 11 weeks

Proportion of patients able to perform all screening tests.Feasibility criteria \>85 %

Training completion rate

时间窗: 10 weeks

Proportion of training sessions carried out with respect to the total.Feasibility criteria \>70 %

Consent rate

时间窗: Baseline

Proportion of participants who provide consent relative to the number approached for participation. Feasibility criteria \> 70%

Divergent treatment decision rate

时间窗: 10 weeks

Proportion of exercises modified based on risk of falls. Feasibility criteria \< 30 %

Adverse effects rate

时间窗: through intervention completion, an average of 11 weeks

Proportion of participants who suffered falls, fatigue or situations that prevent them from continuing with the training. feasibility criteria \< 30 %

次要结局

  • Borg scale(through intervention completion, an average of 11 weeks)
  • Mini Mental State Examination (MMSE)(Baseline and 11 week)
  • Trail making Test (TMT)(Baseline and 11 week)
  • Short physical performance battery (SSPB)(Baseline and 11 week)
  • Barthel index(Baseline and 11 week)
  • 2 minute walk test (2-MWT)(Baseline and 11 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marta Aguilar

Assistant Professor

University of Valencia

研究点 (1)

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