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Completed

NCT Number: NCT04842734

Comparison of the Effect of Online Physical Exercise and Computerized Cognitive Stimulation in Patients With Alzheimer's Disease

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.

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Key information

Conditions

Alzheimer Disease Behavior Brain Diseases COVID-19 COVID-19 Pandemic Central Nervous System Diseases Computerized Cognitive Stimulation Coronaviridae Infections Coronavirus Infections Dementia Infections Lung Diseases Mental Disorders Motor Activity Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nidovirales Infections Online Physical Exercise Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Tauopathies Telerehabilitation Virus Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yeditepe University

Istanbul, Eyalet/Yerleşke, 34865, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical exercise

Other

SPEP are planned for 12 weeks, 2 times a week, once a day, 60 minutes / 1 hour

Physical exercise and computerized cognitive training

Other

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

Primary outcomes

  1. Alzheimer's Disease Related Quality of Life Scale

    Time frame: 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).

  2. Montreal Cognitive Assessment Scale

    Time frame: 24 weeks

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

  3. Berg Balance Scale

    Time frame: 24 weeks

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

  4. Time up and Go Test

    Time frame: 24 weeks

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

  5. Sit to Stand Test

    Time frame: 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

  6. Arm Curl Test

    Time frame: 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

Secondary outcomes

  1. Katz Activities of Daily Living Scale

    Time frame: 24 weeks

    Katz ADLs consist of six questions that include information about bathing, dressing, toilet, movement, excretion, and feeding activities.

  2. Lawton Instrumental Activities of Daily Living Scale

    Time frame: 24 weeks

    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

  3. Geriatric Depression Scale (Short Form)

    Time frame: 24 weeks

    The GDS Short Form (GDS-15) is a 15-item scale that is used for the diagnosis of depression in elderly individuals

Sponsors and collaborators

Lead sponsor

Yeditepe University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 13, 2021
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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