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

Not Applicable

Recruiting

• Conditions: Dementia, Mild; Cognitive Dysfunction
• Interventions: Other: Conventional exercise program; Device: FitMi AD

• Registration Number: NCT05504811
• Lead Sponsor: Flint Rehabilitation Devices, LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-12
• Study First Submitted QC: 2022-08-15
• Study First Posted: 2022-08-17
• Study Start: 2023-03-01
• Status Verified: 2024-09
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26
• Primary Completion: 2025-03-25
• Study Completion: 2025-04-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator: Conventional booklet of exercise program	Conventional 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.
Experimental: FitMi AD Exercise Program	FitMi AD	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rancho Research Institute, Inc; 🇺🇸 Downey, California, United States