Cognitive Dysfunction, Dementia, Mild
Conditions
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.
Interventions
DEVICEFitMi AD
Exercise using the motion sensing devices and a tablet computer
Exercise following printed sheets or booklet
Sponsors
Rancho Research Institute, Inc.
Flint Rehabilitation Devices, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Single (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Duration of exercise performed | Immediately Post-Treatment (an average of 3 months) | Duration of exercise performed over intervention period. |
| 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. |
Countries
United States
Outcome results
None listed