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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04842734
Other study ID # 25.03.2021/37
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 27, 2021
Est. completion date December 25, 2021

Study information

Verified date July 2022
Source Yeditepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 25, 2021
Est. primary completion date July 23, 2021
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - = 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. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Physical exercise
SPEP are planned for 12 weeks, 2 times a week, once a day, 60 minutes / 1 hour
Physical exercise and computerized cognitive training
SPEP are planned for 12 weeks, 2 times a week, once a day, 60 minutes / 1 hour. The CCSP is planned for 12 weeks, minimum 3 to maximum 5 days a week, approximately 10 minutes, for a total of 36-60 sessions

Locations

Country Name City State
Turkey Yeditepe University Istanbul Eyalet/Yerleske

Sponsors (1)

Lead Sponsor Collaborator
Yeditepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Alzheimer's Disease Related Quality of Life Scale 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). 24 weeks
Primary Montreal Cognitive Assessment Scale MOCA is a short cognitive assessment method developed to detect particularly mild stages of cognitive impairment. 24 weeks
Primary Berg Balance Scale Berg Balance Scale measures static and dynamic balance in elderly individuals. 24 weeks
Primary Time up and Go Test TUG test evaluates fall risk, mobility and physical performance in the elderly 24 weeks
Primary Sit to Stand Test 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 24 weeks
Primary Arm Curl Test The Arm Curl test is one of the subtests of the Senior fitness test and it is performed to evaluate upper extremity muscle strength 24 weeks
Secondary Katz Activities of Daily Living Scale Katz ADLs consist of six questions that include information about bathing, dressing, toilet, movement, excretion, and feeding activities. 24 weeks
Secondary Lawton Instrumental Activities of Daily Living Scale Lawton IADL scale consists of 8 items and a single subscale. In addition, it consists of eight questions about using the phone, preparing meals, shopping, doing daily household chores, washing clothes, getting on the transportation vehicle, taking medicines and money management 24 weeks
Secondary Geriatric Depression Scale (Short Form) The GDS Short Form (GDS-15) is a 15-item scale that is used for the diagnosis of depression in elderly individuals 24 weeks
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