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临床试验/NCT07417748
NCT07417748进行中(未招募)不适用

The Effect of Kinesthetic Brain Exercises on Cognitive Function in Patients With Heart Failure

Ege University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年2月11日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Cognitive Function

研究概览

简要总结

The aim of this study is to determine the possible effect of kinesthetic brain exercises on cognitive function in patients with heart failure.

The study will include 40 volunteer individuals aged 30-65 years who have been diagnosed with heart failure in the Cardiology Department and are followed up with a physiotherapy program. Individuals will be randomized into a kinesthetic brain exercise program group (n=20) and a control group (n=20).

The control group will receive routine medication monitoring as well as a routine physiotherapy program. The education group will receive routine medication monitoring and a routine physiotherapy program, in addition to individual kinesthetic brain exercise training. Kinesthetic brain exercises will be performed for 30 minutes, 2 days a week for 8 weeks. Demographic information of the individuals will be collected; age, gender, body mass index, age at diagnosis, ejection fraction ratio, family history, smoking status (years/pack). Cognitive function; The Montreal Cognitive Assessment Scale (MoCA), quality of life using the Minnesota Heart Failure Living Questionnaire, and cognitive performance using the Standardized Minimental Test (SMMT) will be used for evaluation. Biochemical analyses will be performed using the Brain-Derived Neurotrophic Factor (BDNF) ELISA kit. Patients in both groups will be evaluated by a physiotherapist before the study and at week 8.

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
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with heart failure
  • Between 30-65 years of age
  • No history of cardiac surgery
  • Cooperative patients

排除标准

  • Diagnosed with or having a history of neurological disease
  • Pregnant or suspected of being pregnant
  • Scoring above 24 on the Mini Mental Test
  • Patients for whom exercise is contraindicated
  • Individuals with a history of orthopedic surgery

研究组 & 干预措施

Exercise

Experimental

干预措施: Kinesthetic brain exercises (Other)

Exercise

Experimental

干预措施: Cardiorespiratory Physiotherapy (Other)

Exercise

Experimental

干预措施: Heart Failure drugs (Drug)

Control

Active Comparator

干预措施: Cardiorespiratory Physiotherapy (Other)

Control

Active Comparator

干预措施: Heart Failure drugs (Drug)

结局指标

主要结局

Cognitive Function

时间窗: Initially and after 8 weeks

Cognitive function will be assessed using the Montreal Cognitive Assessment Scale (MoCA). The MoCA was developed as a rapid screening test for mild cognitive impairment. The MoCA assesses various cognitive functions, including attention and concentration, executive functions, memory, language, visual construction skills, abstract thinking, calculation, and orientation. The test is scored between 0 and 30 points. A score of 21 or higher is considered normal.

Biochemical analyses

时间窗: Initially and after 8 weeks

Brain-derived neurotrophic factor (BDNF) will be examined through biochemical analyses.

Cognitive Performance

时间窗: Initially and after 8 weeks

The Standardized Mini-Mental Test (SMMT) will be used to assess cognitive performance. Test scores range from 0 to 30. The threshold for the Mini-Mental Test is 22-23 for educated individuals and 18-19 for uneducated individuals. In assessments for individuals with dementia, scores between 25-30 indicate normal cognitive function, 21-24 indicate mild dementia, 10-20 indicate mild-to-moderate dementia, and 0-9 indicate advanced dementia.

次要结局

  • Quality of life in heart failure(Initially and after 8 weeks)

研究者

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

Ozden Gokcek

Assistant Professor

Ege University

研究点 (1)

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