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Completed

NCT Number: NCT05504811

FitMi AD Home Therapy for Individuals With MCI or Mild Dementia Due to Alzheimer's Disease

This study will investigate the efficacy of a newly developed exercise device (FitMi AD) for individuals with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease. FitMi AD uses embedded sensors that can track and record the patient's direction and degree of movement while performing exercises described on a computer.

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Key information

Conditions

Cognitive Dysfunction Brain Diseases Central Nervous System Diseases Cognition Disorders Dementia Dementia, Mild Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mental Disorders Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neurocognitive Disorders

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rancho Research Institute, Inc

Downey, California, 90242, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • have MCI or mild dementia due to AD (i.e. Clinical Dementia Rating (CDR) score 1 for mild dementia or 0.5 for MCI)
  • ability to clearly see the screen and hear the audio instructions from the tablet
  • have a family member or friend who can answer questions about the participant's daily living skills
  • willing to participate in a research study.

Exclusion criteria

  • age < 50 years old
  • use of a wheelchair as a primary mobility device (use of a cane or walker is permitted)
  • presence of other neurologic conditions such as movement disorders or history of stroke
  • other severe concurrent medical conditions that may prevent the participants from completing the 3-month study

Treatment and study plan

FitMi AD

Device

Exercise using the motion sensing devices and a tablet computer

Conventional Exercise Program

Other

Exercise following printed sheets or booklet

Primary outcomes

  1. Change in Functional Reach Test

    Time frame: Baseline, Immediately Post-Treatment (an average of 3 months)

    How far can someone reach while standing in a fixed position

  2. Change in Timed Up and Go Test

    Time frame: Baseline, Immediately Post-Treatment (an average of 3 months)

    Time it takes to stand up from a chair and walk a short distance

  3. Change in 30 Second Chair Stand Test

    Time frame: Baseline, Immediately Post-Treatment (an average of 3 months)

    How many times someone stand up from a chair in 30 seconds

Secondary outcomes

  1. Duration of Exercise Performed

    Time frame: Immediately Post-Treatment (an average of 3 months)

    Duration of exercise performed over intervention period.

Other outcomes

  1. Visual Analog Pain Scale

    Time frame: Baseline, Immediately Post-Treatment (an average of 3 months)

    Indicates perceived pain intensity. The scale consists of a line, often 10 cm long, with verbal anchors at either end (i.e. "no pain" on the far left and "the most intense pain imaginable" on the far right). The patient places a mark at a point on the line corresponding to the patient's rating of pain intensity.

  2. Global Physical Activity Questionnaire

    Time frame: Baseline, Immediately Post-Treatment (an average of 3 months)

    Assesses physical activity habits

  3. Geriatric Depression Scale

    Time frame: Baseline, Immediately Post-Treatment (an average of 3 months)

    Evaluates depression in elderly individuals. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.

  4. Pittsburgh Sleep Quality Index

    Time frame: Baseline, Immediately Post-Treatment (an average of 3 months)

    Measures the quality and patterns of sleep in adults. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

Sponsors and collaborators

Lead sponsor

Flint Rehabilitation Devices, LLC

Industry

Collaborators

  • Rancho Research Institute, Inc.

Registry information

Official study title

FitMi AD: a Safe and Motivating Computer-guided Exercise System for Individuals With MCI or Mild Dementia Due to Alzheimer's Disease

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 17, 2022
Registry last updated
Jul 20, 2026

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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