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

Study Overview
=================
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.

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

Conditions
-----------------
Cognitive Dysfunction, Dementia, Mild

Intervention / Treatment
-----------------
* Device: FitMi AD
* Other: Conventional exercise program


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: FitMi AD Exercise Program<br>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<br>* Exercise using the motion sensing devices and a tablet computer<br>|
| Active Comparator: Active Comparator: Conventional booklet of exercise program<br>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<br>* Exercise following printed sheets or booklet<br>|

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) |