ACTRN12617001440314终止未知
BRAIN Training Trial: A randomised controlled trial of Balance, Resistance, or INterval Training on cognitive function in older adults with Mild Cognitive Impairment.
试验速览
- 阶段
- 未知
- 状态
- 终止
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 60 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Mild Cognitive Impairment (MCI) defined as the presence of all four generally accepted criteria (*)
- •1.1. Absence of dementia: Clinical Dementia Rating scale (CDR) score below 1.
- •1.2. No or minimal functional impairment due to cognition: Amsterdam IADL
- •Questionnaire score equal or greater than 40, rated by informant or participant if no
- •informant available.
- •1.3. Subjective memory/cognitive complaint:
- •a) Cognitive Change Index (CCI) scale:
- •Participant or informant responds to 3 or more statements with a rating of 3, 4 or 5
- •(‘mild to severe problem’); OR
- •b) Subjective memory complaint questionnaire: Participant or informant responds ‘yes’
- •to question (1): ‘Have you noticed difficulties with your memory?’ and ‘yes’ to questions
- •2 OR 3: (2)‘Have you been concerned about your memory?, (3)Have you mentioned
- •any concerns about memory to anyone? respectively, as per recommendations for
- •the assessment of subjective memory complaint.
- •1.4. Objective cognitive impairment: Score between 19 and 25 on the Montreal
- •Cognitive Assessment (MoCA).
- •2. Age 60 or above
- •3. Ambulatory without the assistance of a person
- •4. If from non-English speaking background, must have completed some education in English.
- •5. Residing in the community, including retirement villages and other senior housing or activity sites (independent level of care)
- •6. Willing to participate in a study which involves attending supervised exercise sessions 3 days per week for 12 months
- •There will be 3-stage screening, which includes: Telephone screen by research assistant of participant and informant (if available) for willingness to participate, sedentary status, no exclusionary medical history, no current mayor depression (PHQ-9 score of 9 or below), no planned move, no planned vacation for more than 4 consecutive weeks during the 12 month stuy period. This will be followed by In-person screen to assess criteria for mild cognitive impairment, and later on by In-person screen by physician to perform medical screen and stress testing (to ascertain unstable or unsuitable medical conditions).
- •(*) Winblad B, Palmer K, Kivipelto M, et al. Mild cognitive impairment-beyond controversies, towards a consensus: report of the International Working Group on Mild Cognitive Impairment. J Intern Med 2004;256:240-6.
排除标准
- •1. Diagnosis of dementia
- •2. High level residential care
- •3. Non-ambulatory or requiring person to assist when walking
- •4. 1 stroke in the past 12 months or 2 or more strokes in a lifetime
- •5. Cardiovascular event/surgery in the past 6 months
- •6. Progressive neurological disease
- •7. Inability to read and identify objects on a computer screen and draw on a piece of paper due to vision impairment
- •8. Current major depressive episode (PHQ-9 score above 9)
- •9. Psychosis or substance abuse according to DSM-IV criteria.
- •10. Alcohol abuse (Responded ‘Yes’ to questions 3 and 4 of the CAGE, and reported risky drinking behaviour using NHMRC standard criteria)
- •11. From a non-English speaking background (NESB) without any education in English
- •12. Already practicing =150 min moderate intensity exercise, PRT or HIIT regularly
- •13. Medical contraindications to the planned exercise due to chronic or unstable or terminal diseases
- •14. Planned move, or planning to be away for 4 or more consecutive weeks during the study period
- •15. Traumatic brain injury or >2 seizures in the past 12 months
研究者
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