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临床试验/NCT07432425
NCT07432425
招募中
不适用

Effects of Different Exercise Protocols on Physical Status, Cognitive Functions, Brain Structure, and Blood Biomarkers in People With Chronic Neck Pain

Hacettepe University1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2025年5月1日最近更新:

概览

阶段
不适用
状态
招募中
入组人数
21
试验地点
1
主要终点
Pain Intensity

概览

简要总结

This study aims to investigate the effects of different exercise approaches on physical status, cognitive functions, brain structures, and blood biomarkers in individuals with chronic neck pain.

详细描述

Chronic neck pain is a common musculoskeletal disorder. It has been stated in the literature that in addition to physical disabilities, cognitive problems may also be observed in these individuals. Still, the neurophysiological and biochemical mechanisms related to these disabilities are not yet sufficiently clear. Previous studies conducted on individuals with chronic neck pain are mostly evaluation studies aimed at existing disabilities, and our planned study seeks to achieve positive improvements in these disabilities by applying a treatment approach known to be effective on physical and cognitive health, such as exercise. Within the scope of the project, neuropsychological tests will be applied to the participants to evaluate attention, memory, visual and spatial structuring, language skills, and executive functions. Participants' brain structural changes will be evaluated with T1-weighted imaging, and brain perfusion changes will be evaluated with Arterial Spin Labeling imaging. Within the scope of physical condition and pain-related evaluations, participants' pain intensity, neck disability levels, muscle strength, functional capacities, pain catastrophizing level, kinesiophobia, central sensitization, and sleep quality will be evaluated. Finally, blood samples of the participants will be collected and serum concentrations of Cortisol, Interleukin 1-Beta, Tumor Necrosis Factor-Alpha, Insulin-Like Growth Factor-1, Interleukin-10, Irisin, Brain-Derived Neurotrophic Factor, Nerve Growth Factor and Cathepsin-B will be examined. All these assessments will be applied both before and after the exercise applications, and only muscle strength and functional capacities will be measured again at the end of the 6th week so that the exercise program can progress according to the gains in physical condition. Individuals whose initial assessments are completed will be assigned to aerobic exercise, strength exercises, or home exercise control group by stratified randomization method. Exercise applications will be applied 3 days a week for 3 months and each participant will participate in a total of 36 exercise sessions individually. It is anticipated that revealing the cognitive, physical, neurophysiological, and biochemical effects of aerobic, strengthening, and home exercise practices in individuals with chronic neck pain and explaining the similarities and superiorities of different exercise practices will pave the way for planning targeted health services.

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
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants aged 20-65
  • Having neck pain at least 3 months and rated as 3 or more according to the Numeric Rating Scale
  • Having a score of 10 or more according to the Neck Disability Index
  • Having a score of 24 or above according to the Mini Mental State Examination
  • Right hand dominancy according to Edinburgh Handedness Inventory
  • Having at least a primary school graduate

排除标准

  • Having neuropsychiatric, neurologic, metabolic, cardiovascular, and inflammatory disease(s)
  • Participating in a rehabilitation program for neck pain in the last 6 months
  • Having an exercise or sports history of 6 months or more
  • Presence of brain parenchymal lesion on MRI
  • Presence of materials in the body such as jewelry, metal, hearing aid, pacemaker, lead that cannot be removed and are not suitable for MRI
  • History of neck or shoulder surgery
  • Being pregnant or having given birth within the last year

研究组 & 干预措施

Aerobic exercise group

Experimental

Aerobic exercise training will be applied 3 days a week for 3 months and each participant will participate in a total of 36 exercise sessions individually.

干预措施: Aerobic exercise (Other)

Strengthening exercise group

Experimental

Strengthening exercise training will be applied 3 days a week for 3 months and each participant will participate in a total of 36 exercise sessions individually.

干预措施: Strengthening exercise (Other)

Posture and stretching exercise group

Other

Posture and stretching exercise training will be applied 3 days a week for 3 months and each participant will participate in a total of 36 exercise sessions individually as the control intervention.

干预措施: Posture and strentching exercise (Other)

结局指标

主要结局

Pain Intensity

时间窗: Baseline, 6th week, and 12th week

Numerical scales are among the frequently used one-dimensional pain intensity scales because they are easy to use and effective. In the application, volunteers are asked to choose the number that best describes their pain intensity. Zero indicates no pain, while 10 represents the worst pain imaginable.

次要结局

未报告次要终点

研究者

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

Songül Atasavun UYSAL

Professor

Hacettepe University

研究点 (1)

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