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临床试验/NCT04842734
NCT04842734已完成不适用

Comparison of the Effect of Online Physical Exercise and Computerized Cognitive Stimulation in Patients With Alzheimer's Disease During the Covid-19 Pandemic

Yeditepe University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年4月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Alzheimer's Disease Related Quality of Life Scale

研究概览

简要总结

Our aim has been determined to investigate the effect of physical exercise alone and in combination with cognitive exercise, on cognitive, physical function and quality of life in individuals with Alzheimer's Disease during the Covid-19 pandemic period.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •≥ 65 years and older
  • •Diagnosed with AD according to DSM-IV diagnostic criteria by a neurologist,
  • •MOCA ≥ 13
  • •Clinical Dementia Rating Scale < 2
  • •Having sufficient wireless support or telephone connection where the person lives
  • •Who gave consent to participate in the study
  • •No history of any neurological or orthopedic injury that could prevent participation in the study and affect functional mobility.

排除标准

  • •Geriatric Depression Scale score > 11
  • •Various mobility restrictions, musculoskeletal disorders, (wheelchair use, etc.)
  • •Clinically significant aphasia (must be able to understand the therapist's commands)
  • •Significant visual or sensory impairment
  • •MoCA < 13
  • •Having a severe musculoskeletal disorder
  • •Having paralysis
  • •Impaired balance
  • •The presence of severe lung and heart disease

研究组 & 干预措施

Physical exercise and computerized cognitive stimulation

Experimental

Supervised Physical Exercise Program (SPEP) sessions will be performed simultaneously online together with the physiotherapist and the patient. Participants will be able to do the exercises together with their caregivers if needed.

The Computerized Cognitive Stimulation Program (CCSP) (Beynex) will be planned for 12 weeks, 5 days a week, approximately 10 minutes, for a total of 40 sessions.

Fisrtly, the use of CCSP will be demonstrated to the patients. Then, it will be given as home program. While the patients play the games in CCSP via their smartphones, their caregivers will be informed in detail about accompanying the patients if they need it. The follow-up of cognitive stimulation will be made with the person accompanying the patient over the phone.

Individuals will be evaluated by a physiotherapist who will perform the assessment at pre-treatment, post-treatment (12th week) and follow-up period (24th week).

干预措施: Physical exercise and computerized cognitive training (Other)

physical exercise

Experimental

SPEP sessions will be demonstrated to individuals by a 6-year-experienced physiotherapist via videoconference (Zoom Inc.) and the exercises will be performed simultaneously online together with the physiotherapist and the patient. Participants will be able to do the exercises together with their caregivers if needed.

Individuals will be evaluated by a physiotherapist who will perform the assessment at pre-treatment, post-treatment (12th week) and follow-up period (24th week).

干预措施: Physical exercise (Other)

control

No Intervention

The individuals included in this group will be informed that they should continue their normal daily life activities.

Individuals will be evaluated by a physiotherapist who will perform the assessment at pre-treatment, post-treatment (12th week) and follow-up period (24th week).

结局指标

主要结局

Alzheimer's Disease Related Quality of Life Scale

时间窗: 24 weeks

This scale evaluates health-related quality of life in individuals with AD. The scale includes 40 questions in total and examines 5 quality of life domains (A-Social Interaction, B-Self Awareness, C-Affect and Mood, D- Enjoying Activities, E-Interaction with the Environment).

Arm Curl Test

时间窗: 24 weeks

The Arm Curl test is one of the subtests of the Senior fitness test and it is performed to evaluate upper extremity muscle strength

Montreal Cognitive Assessment Scale

时间窗: 24 weeks

MOCA is a short cognitive assessment method developed to detect particularly mild stages of cognitive impairment.

Berg Balance Scale

时间窗: 24 weeks

Berg Balance Scale measures static and dynamic balance in elderly individuals.

Time up and Go Test

时间窗: 24 weeks

TUG test evaluates fall risk, mobility and physical performance in the elderly

Sit to Stand Test

时间窗: 24 weeks

Sit-to-stand test will be performed on an armless chair with a height of 46 cm to determine the physical fitness level of elderly individuals

次要结局

  • Katz Activities of Daily Living Scale(24 weeks)
  • Lawton Instrumental Activities of Daily Living Scale(24 weeks)
  • Geriatric Depression Scale (Short Form)(24 weeks)

研究者

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

Ebru Akbuğa Koç

Lecturer

Yeditepe University

研究点 (1)

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