Trial Outcomes & Findings for Socially Isolated Older Adults Living With Dementia (NCT NCT03666624)
NCT ID: NCT03666624
Last Updated: 2022-02-02
Results Overview
Minutes spent on exercising per week in the past month were calculated from the following two questions: (1) How much time did you spend on exercises (hours per day) on a typical day during the last month; (2) How many days did you spend on exercises during the last month.
COMPLETED
NA
30 participants
Baseline (pre-treatment) and 7 weeks (post-treatment)
2022-02-02
Participant Flow
Participant milestones
| Measure |
Personalized Care Network
9 60-minute virtual sessions for 6 weeks plus personalized exercise coaching once a week for 6 weeks
Personalized care network: The Personalized care network intervention includes exercise training for participant with dementia and behavioral management training for addressing challenges.
|
Routine Medical Care
No intervention
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Personalized Care Network
9 60-minute virtual sessions for 6 weeks plus personalized exercise coaching once a week for 6 weeks
Personalized care network: The Personalized care network intervention includes exercise training for participant with dementia and behavioral management training for addressing challenges.
|
Routine Medical Care
No intervention
|
|---|---|---|
|
Overall Study
participant grieving over recent death of parent
|
1
|
0
|
Baseline Characteristics
Socially Isolated Older Adults Living With Dementia
Baseline characteristics by cohort
| Measure |
Personalized Care Network
n=14 Participants
9 60-minute virtual sessions for 6 weeks plus personalized exercise coaching once a week for 6 weeks
Personalized care network: The Personalized care network intervention includes exercise training for participant with dementia and behavioral management training for addressing challenges.
|
Routine Medical Care
n=15 Participants
No intervention
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
68.8 years
STANDARD_DEVIATION 2.0 • n=7 Participants
|
68.6 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-treatment) and 7 weeks (post-treatment)Minutes spent on exercising per week in the past month were calculated from the following two questions: (1) How much time did you spend on exercises (hours per day) on a typical day during the last month; (2) How many days did you spend on exercises during the last month.
Outcome measures
| Measure |
Personalized Care Network
n=14 Participants
9 60-minute virtual sessions for 6 weeks plus personalized exercise coaching once a week for 6 weeks
Personalized care network: The Personalized care network intervention includes exercise training for participant with dementia and behavioral management training for addressing challenges.
|
Routine Medical Care
n=15 Participants
No intervention
|
|---|---|---|
|
Change in Physical Activity
Unadjusted mean at baseline
|
227 minutes per week
Standard Error 69
|
282 minutes per week
Standard Error 129
|
|
Change in Physical Activity
Unadjusted mean at 7 weeks
|
380 minutes per week
Standard Error 105
|
232 minutes per week
Standard Error 76
|
PRIMARY outcome
Timeframe: Baseline (pre-treatment) and 7 weeks (post-treatment)Physical Functioning subscale of the Medical Outcomes Study 36-Item Short Form (SF-36) consists of 10 items and measures how much participants' health status limits their activities including walking, climbing, lifting, and bathing or dressing oneself, based on self-reports. Each item is measured a 3-point scale (1 = Yes, limited a lot; 2 = Yes, limited a little; 3 = No, not limited at all), then recoded into 0, 50, and 100, respectively. The recoded scores are averaged to generate a summary score with its possible range from 0 to 100. Higher scores indicate better physical functioning.
Outcome measures
| Measure |
Personalized Care Network
n=14 Participants
9 60-minute virtual sessions for 6 weeks plus personalized exercise coaching once a week for 6 weeks
Personalized care network: The Personalized care network intervention includes exercise training for participant with dementia and behavioral management training for addressing challenges.
|
Routine Medical Care
n=15 Participants
No intervention
|
|---|---|---|
|
Change in Physical Functioning
Unadjusted score at baseline
|
66.1 score on a scale
Standard Error 6.7
|
73.0 score on a scale
Standard Error 6.1
|
|
Change in Physical Functioning
Unadjusted score at 7 weeks
|
73.2 score on a scale
Standard Error 7.3
|
72.0 score on a scale
Standard Error 6.2
|
SECONDARY outcome
Timeframe: Baseline (pre-treatment) and 7 weeks (post-treatment)Quality of Life in Alzheimer's Disease (QOL-AD) is a 13-item scale that measures participant's self-reported feelings about different aspects of life including energy, mood, living situation, memory, family, friends, ability, and money. Each item has a 4-point response scale (1 = poor; 2 = fair; 3 = good; 4 = excellent). The summary score is a sum of the 13 items with its possible range from 13 to 52. Higher scores indicate higher quality of life.
Outcome measures
| Measure |
Personalized Care Network
n=14 Participants
9 60-minute virtual sessions for 6 weeks plus personalized exercise coaching once a week for 6 weeks
Personalized care network: The Personalized care network intervention includes exercise training for participant with dementia and behavioral management training for addressing challenges.
|
Routine Medical Care
n=15 Participants
No intervention
|
|---|---|---|
|
Change in Quality of Life
Unadjusted score at baseline
|
30.9 score on a scale
Standard Error 2.3
|
32.2 score on a scale
Standard Error 1.8
|
|
Change in Quality of Life
Unadjusted score at 7 weeks
|
32.7 score on a scale
Standard Error 3.3
|
32.0 score on a scale
Standard Error 1.5
|
Adverse Events
Personalized Care Network
Routine Medical Care
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