Trial Outcomes & Findings for FitMi AD Home Therapy for Individuals With MCI or Mild Dementia Due to Alzheimer's Disease (NCT NCT05504811)
NCT ID: NCT05504811
Last Updated: 2026-07-20
Results Overview
How far can someone reach while standing in a fixed position
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
Baseline, Immediately Post-Treatment (an average of 3 months)
Results posted on
2026-07-20
Participant Flow
31 total participants were recruited across two study sites: Rancho Los Amigos National Rehabilitation Center and Havana Research Institute.
All enrolled participants completed the study.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
16
|
|
Overall Study
COMPLETED
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Some participants declined to report.
Baseline characteristics by cohort
| Measure |
Experimental: FitMi AD Exercise Program
n=15 Participants
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.
|
Active Comparator: Conventional Booklet of Exercise Program
n=16 Participants
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.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.5 years
STANDARD_DEVIATION 8.8 • n=14 Participants • Some participants declined to report.
|
71.3 years
STANDARD_DEVIATION 10.4 • n=14 Participants • Some participants declined to report.
|
72 years
STANDARD_DEVIATION 9.3 • n=28 Participants • Some participants declined to report.
|
|
Sex: Female, Male
Female
|
6 Participants
n=14 Participants • Some participants declined to report.
|
9 Participants
n=15 Participants • Some participants declined to report.
|
15 Participants
n=29 Participants • Some participants declined to report.
|
|
Sex: Female, Male
Male
|
8 Participants
n=14 Participants • Some participants declined to report.
|
6 Participants
n=15 Participants • Some participants declined to report.
|
14 Participants
n=29 Participants • Some participants declined to report.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=15 Participants
|
1 Participants
n=16 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=15 Participants
|
15 Participants
n=16 Participants
|
29 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=15 Participants
|
10 Participants
n=16 Participants
|
21 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=15 Participants
|
6 Participants
n=16 Participants
|
10 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline, Immediately Post-Treatment (an average of 3 months)How far can someone reach while standing in a fixed position
Outcome measures
| Measure |
Experimental: FitMi AD Exercise Program
n=14 Participants
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.
|
Active Comparator: Conventional Booklet of Exercise Program
n=16 Participants
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.
|
|---|---|---|
|
Change in Functional Reach Test
|
-0.21 centimeters
Standard Deviation 2.27
|
-0.16 centimeters
Standard Deviation 3.36
|
PRIMARY outcome
Timeframe: Baseline, Immediately Post-Treatment (an average of 3 months)Time it takes to stand up from a chair and walk a short distance
Outcome measures
| Measure |
Experimental: FitMi AD Exercise Program
n=14 Participants
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.
|
Active Comparator: Conventional Booklet of Exercise Program
n=16 Participants
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.
|
|---|---|---|
|
Change in Timed Up and Go Test
|
-0.50 Seconds
Standard Deviation 3.33
|
-1.05 Seconds
Standard Deviation 2.77
|
PRIMARY outcome
Timeframe: Baseline, Immediately Post-Treatment (an average of 3 months)How many times someone stand up from a chair in 30 seconds
Outcome measures
| Measure |
Experimental: FitMi AD Exercise Program
n=14 Participants
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.
|
Active Comparator: Conventional Booklet of Exercise Program
n=16 Participants
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.
|
|---|---|---|
|
Change in 30 Second Chair Stand Test
|
-0.07 number of times the patient stands in 30
Standard Deviation 0.59
|
-0.19 number of times the patient stands in 30
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: Immediately Post-Treatment (an average of 3 months)Duration of exercise performed over intervention period.
Outcome measures
| Measure |
Experimental: FitMi AD Exercise Program
n=15 Participants
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.
|
Active Comparator: Conventional Booklet of Exercise Program
n=16 Participants
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.
|
|---|---|---|
|
Duration of Exercise Performed
|
43.31 days
Standard Deviation 23.16
|
60.87 days
Standard Deviation 11.34
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Immediately Post-Treatment (an average of 3 months)Assesses physical activity habits
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
Adverse Events
Experimental: FitMi AD Exercise Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Comparator: Conventional Booklet of Exercise Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place