跳至主要内容
临床试验/NCT05691842
NCT05691842招募中不适用

Efficacy of a High-Intensity Interval Exercise Program Versus a Dual-Task Training Program in People With Alzheimer's: A Randomized Clinical Trial

University of Valencia1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2022年12月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
66
试验地点
1
主要终点
Change from baseline balance ability

研究概览

简要总结

Alzheimer's disease (AD) is a the most common type of dementia. It is a progressive disease that affects different areas of human behavior at the cognitive, social, physical and metabolic levels. The benefits of a High-Intensity Interval Exercise Program (HIIT) has been proven not only in healthy older adults, but also in different pathologies, such as cerebrovascular and cardiometabolic diseases. However, there are no studies to date that examine the impact of HIIT in people with AD. The aim of this study was to ascertain the effectiveness of a HIIT program versus a cognitive and motor dual task balance program on parameters related to functional capacity and cognitive function in people with AD.

详细描述

Alzheimer's disease (AD) is a the most common type of dementia. It is a progressive disease that affects different areas of human behavior at the cognitive, social, physical and metabolic levels.

The benefits of interventions such as dual-task training (TD) have been the focus of studies in recent years in AD. Current evidence shows that DT training leads to improvements in parameters related to frontal cognitive function, such as: planning, organization, strategy creation, abstraction, motor sequencing, working memory, thinking flexibility, visual search, sequencing, sustained attention and working memory. DT training has been also shown to improve variables related to gait ability and balance, such as step length and gait speed, postural control and specific functional tasks under challenging conditions of double task. However, AD is also associated with reduced cardiovascular fitness and decreased muscle strength, thus leading to a loss of independence in activities of daily living and poor quality of life.

A promising intervention to address these issues is high-intensity interval exercise (HIIT), defined as brief intermittent bursts of vigorous activity interspersed with periods of rest or low-intensity exercise. Indeed, it has been reported that HIIT generates greater benefits in cardiorespiratory capacity and greater metabolic adaptations than continuous exercise of moderate intensity in healthy older adults. HIIT interventions have resulted in benefits on variables related to functional capacity, such as improved gait speed, increased muscle mass and strength. Furthermore, HIIT has been shown to improve variables related to cognitive function, such as attention, perception and memory abilities.

However, there are no studies to date that examine the impact of HIIT in people with AD. The aim of this study was to ascertain the effectiveness of a HIIT program versus a cognitive and motor dual task balance program on parameters related to functional capacity and cognitive function in people with AD.

Therefore, a randomized clinical trial will be carried out, in which three groups of twenty people in each group will participate, with different interventions:

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 (Participant)

入排标准

年龄范围
60 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged between 60 -90 years
  • •Diagnosed with mild or moderate AD according to the Clinical Dementia Rating (CDR1).
  • •Ability to follow the instructions of the training program.
  • •Ability to get up from a chair alone.
  • •Independent ambulation.
  • •Providing signed informed consent.

排除标准

  • •Dementia or severe cognitive impairment that makes it impossible to understand instructions.
  • •Presence of other neurological pathologies such as: stroke, Parkinson's or cranioencephalic trauma.
  • •Severe cardiovascular disorders.
  • •Severe visual deficits.
  • •Other limitations that make it difficult to ambulate.
  • •Participating in any high intensity exercise program.

研究组 & 干预措施

HIIT intervention

Experimental

Patients in this group (n=22) will undergo a HIIT training protocol for 12 weeks

干预措施: HIIT intervention (Other)

Dual task intervention (DT)

Experimental

Patients in this group (n=22) will undergo a DT training protocol for 12 weeks

干预措施: Dual task intervention (Other)

Control group (CG)

No Intervention

Patients in this group (n=22) will not perform any exercise during the intervention period (12 weeks)

结局指标

主要结局

Change from baseline balance ability

时间窗: At baseline, post-intervention and at 2 month-follow-up

Star Excursion Balance Test: maximal distance in all directions (cm), 3 times

Change from baseline cardiorespiratory fitness

时间窗: At baseline, immediately after the intervention and at 2 month-follow-up

6 minutes walking test" (6MWT): distance (m)

次要结局

  • Change from baseline lower limb isometric strength(At baseline, immediately after the intervention and at 2 month-follow-up)
  • Fall frequency(Daily for 12 weeks (the length of the intervention))
  • Change from baseline Cognitive status(At baseline, immediately after the intervention and at 2 month-follow-up)
  • Change from baseline Risk of Falling(At baseline, immediately after the intervention and at 2 month-follow-up)
  • Change from baseline Executive function status(At baseline, immediately after the intervention and at 2 month-follow-up)
  • Change from baseline depression levels(At baseline, immediately after the intervention and at 2 month-follow-up)
  • Change from baseline lower limb power(At baseline, immediately after the intervention and at 2 month-follow-up)
  • Change from baseline Fear of falling(At baseline, immediately after the intervention and at 2 month-follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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