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

FitMi AD: a Safe and Motivating Computer-guided Exercise System 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.

Study Overview

• Status: Completed
• Conditions: Cognitive Dysfunction; Dementia, Mild
• Intervention / Treatment: Device: FitMi AD; Other: Conventional exercise program

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Downey, California, United States, 90242
      • Rancho Research Institute, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: FitMi AD Exercise Program; Participants will perform exercises by interacting with FitMi pucks, as described and monitored on a tablet computer. Participants will be asked to exercise at least 30 minutes per day for 3 months.	Device: FitMi AD; Exercise using the motion sensing devices and a tablet computer
Active Comparator: Active Comparator: Conventional booklet of exercise program; Participants will perform exercises described in a booklet similar to what is typically provided to individuals. Participants will be asked to exercise at least 30 minutes per day for 3 months.	Other: Conventional exercise program; Exercise following printed sheets or booklet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional Reach Test	How far can someone reach while standing in a fixed position	Baseline, Immediately Post-Treatment (an average of 3 months)
Change in Timed Up and Go test	Time it takes to stand up from a chair and walk a short distance	Baseline, Immediately Post-Treatment (an average of 3 months)
Change in 30 second chair stand test	How many times someone stand up from a chair in 30 seconds	Baseline, Immediately Post-Treatment (an average of 3 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Pain Scale	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.	Baseline, Immediately Post-Treatment (an average of 3 months)
Global Physical Activity Questionnaire	Assesses physical activity habits	Baseline, Immediately Post-Treatment (an average of 3 months)
Geriatric Depression Scale	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.	Baseline, Immediately Post-Treatment (an average of 3 months)
Pittsburgh Sleep Quality Index	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.	Baseline, Immediately Post-Treatment (an average of 3 months)
Duration of exercise performed	Duration of exercise performed over intervention period.	Immediately Post-Treatment (an average of 3 months)

Collaborators and Investigators

• Sponsor: Flint Rehabilitation Devices, LLC
• Collaborators: Rancho Research Institute, Inc.
• Investigators: Principal Investigator: Freddi Segal-Gidan, PA, PhD, Rancho Research Institute, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2023
• Primary Completion (Actual): March 12, 2025
• Study Completion (Actual): March 12, 2025

Study Registration Dates

• First Submitted: August 12, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Neurocognitive Disorders; Cognition Disorders; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hemic and Lymphatic Diseases; Cognitive Dysfunction; Lymphoma, Follicular; Dementia
• Other Study ID Numbers: 2R44AG063651-02 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No