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临床试验/NCT06823921
NCT06823921Enrolling By Invitation不适用

Effects of High-Intensity Interval Training (HIIT) on Cognitive Function and Quality of Life in Parkinson's Disease: A Pilot Clinical Trial

Sule Tinaz1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年2月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
30
试验地点
1
主要终点
Quality of Life in Neurological Disorders (Neuro-QoL) cognitive function survey

研究概览

简要总结

This pilot study will evaluate the short-term (3 months) and long-term (6 months) effectiveness of a high-intensity interval training (HIIT) program in improving cognitive function and self-efficacy in individuals with PD.

详细描述

Participants will be assigned to either the HIIT group, which will engage in 3 classes per week, or a standard-of-care control group, which will include people who will continue their standard care and usual physical activities but do not plan on partaking in additional structured exercise interventions for 3 months (except for physical and occupational therapy if medically necessary). Cognitive functions will be measured using standardized tests (Stroop, Trail Making Test-B (TMT-B), verbal fluency (using letters F-A-S), and Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)), alongside assessing subjective ratings of daily cognitive function using the Neuro Quality of Life - Cognitive Function (Neuro-QoL CF) survey. Secondary outcomes will include self-efficacy measures, specifically regarding goal achievement, managing emotions and daily activities. We will also aim to obtain brain functional MRI (fMRI) and neuromelanin-sensitive MRI (NM-MRI) data from a subset of participants to measure the brain effects of HIIT as exploratory outcomes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •Diagnosis of idiopathic Parkinson's disease
  • •Age 40 year and above
  • •Willingness and ability to participate in HIIT exercise classes

排除标准

  • •Non-English speaking
  • •Neuropsychiatric disorder other than Parkinson's disease and comorbid depression and anxiety (e.g., stroke, epilepsy, brain tumor, multiple sclerosis, schizophrenia, bipolar disorder, obsessive compulsive disorder, etc.)
  • •High levels of exercise at baseline (exercising at high intensity at least 3 times per week or moderate intensity at least 5 times per week)
  • •Hoehn & Yahr disease stage > 3 (physically not independent)

研究组 & 干预措施

High-intensity interval training

Experimental

Participants in the HIIT group will be expected to attend 3 exercise classes per week for 3 months

干预措施: Exercise (Other)

Control

No Intervention

Participants in the control group will continue their standard care and usual physical activities

结局指标

主要结局

Quality of Life in Neurological Disorders (Neuro-QoL) cognitive function survey

时间窗: 3 months and 6 months

Subjective measures of cognitive functioning in daily life. It captures aspects of cognitive functioning such as attention, memory, and executive function. The average T-score is 50. Higher score indicates better performance.

次要结局

  • Executive function composite T-score(3 months and 6 months)
  • Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) memory domain index score(3 months and 6 months)

研究者

发起方
Sule Tinaz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sule Tinaz

Associate Professor of Neurology

Yale University

研究点 (1)

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