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
Flint Rehabilitation Devices, LLC
Rancho Research Institute, Inc.
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 |
|---|---|---|
| Duration of Exercise Performed | Immediately Post-Treatment (an average of 3 months) | Duration of exercise performed over intervention period. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFreddi Segal-Gidan, PA, PhD
Rancho Research Institute, Inc.
Participant flow
Recruitment details
31 total participants were recruited across two study sites: Rancho Los Amigos National Rehabilitation Center and Havana Research Institute.
Pre-assignment details
All enrolled participants completed the study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 72 years STANDARD_DEVIATION 9.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 29 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 16 |
| other Total, other adverse events | 0 / 15 | 0 / 16 |
| serious Total, serious adverse events | 0 / 15 | 0 / 16 |
Outcome results
None listed