Trial Outcomes & Findings for Preventing Loss of Independence Through Exercise (PLIE) in Persons With Dementia (NCT NCT02350127)
NCT ID: NCT02350127
Last Updated: 2020-06-18
Results Overview
The Quality of Life Scale in Alzheimer's Disease (QOL-AD) is a standard quality of life measure that asks parallel questions of affected individuals and caregivers. Current quality of life is rated as poor (1 point), fair (2 points), good (3 points) or excellent (4 points) in 13 areas: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores around the house, ability to do things for fun, money, and life as a whole. Scores may range from 13 to 52 with higher scores reflecting better quality of life. Prior studies have found that the QOL-AD is a valid and reliable measure, with Cronbach's alpha of 0.84 for patient reports and 0.86 for caregiver reports and interrater reliability based on Cohen's kappa values \>0.70.
COMPLETED
PHASE2/PHASE3
88 participants
4 months
2020-06-18
Participant Flow
Participant milestones
| Measure |
Immediate Start
The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
|
Delayed Start
Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
|
|---|---|---|
|
4-Month Assessment
STARTED
|
44
|
44
|
|
4-Month Assessment
Completed Baseline
|
42
|
43
|
|
4-Month Assessment
COMPLETED
|
33
|
35
|
|
4-Month Assessment
NOT COMPLETED
|
11
|
9
|
|
8-Month Assessment
STARTED
|
33
|
35
|
|
8-Month Assessment
COMPLETED
|
27
|
26
|
|
8-Month Assessment
NOT COMPLETED
|
6
|
9
|
Reasons for withdrawal
| Measure |
Immediate Start
The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
|
Delayed Start
Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
|
|---|---|---|
|
4-Month Assessment
Withdrawal by Subject
|
10
|
9
|
|
4-Month Assessment
Death
|
1
|
0
|
|
8-Month Assessment
Death
|
1
|
1
|
|
8-Month Assessment
Withdrawal by Subject
|
5
|
8
|
Baseline Characteristics
The MOCA was administered immediately after obtaining informed consent and was missing for 2 participants. The baseline assessment was typically performed at a separate visit. Some participants withdrew after consenting but before completing the baseline assessment, and their scores are included.
Baseline characteristics by cohort
| Measure |
Immediate Start
n=44 Participants
The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
|
Delayed Start
n=44 Participants
Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=44 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=88 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=44 Participants
|
1 Participants
n=44 Participants
|
2 Participants
n=88 Participants
|
|
Age, Categorical
>=65 years
|
43 Participants
n=44 Participants
|
43 Participants
n=44 Participants
|
86 Participants
n=88 Participants
|
|
Age, Continuous
|
80.0 years
STANDARD_DEVIATION 7.8 • n=44 Participants
|
79.0 years
STANDARD_DEVIATION 7.3 • n=44 Participants
|
79.5 years
STANDARD_DEVIATION 7.6 • n=88 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=44 Participants
|
15 Participants
n=44 Participants
|
29 Participants
n=88 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=44 Participants
|
29 Participants
n=44 Participants
|
59 Participants
n=88 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Non-Hispanic White
|
38 Participants
n=44 Participants
|
38 Participants
n=44 Participants
|
76 Participants
n=88 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
3 Participants
n=44 Participants
|
1 Participants
n=44 Participants
|
4 Participants
n=88 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black/African American
|
3 Participants
n=44 Participants
|
1 Participants
n=44 Participants
|
4 Participants
n=88 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Native Hawaiian/Pacific Islander
|
0 Participants
n=44 Participants
|
1 Participants
n=44 Participants
|
1 Participants
n=88 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic/Latino (any race)
|
0 Participants
n=44 Participants
|
2 Participants
n=44 Participants
|
2 Participants
n=88 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Multiple/Other
|
0 Participants
n=44 Participants
|
1 Participants
n=44 Participants
|
1 Participants
n=88 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=44 Participants
|
44 participants
n=44 Participants
|
88 participants
n=88 Participants
|
|
Participant MOCA Score
|
10.7 units on a scale
STANDARD_DEVIATION 7.3 • n=43 Participants • The MOCA was administered immediately after obtaining informed consent and was missing for 2 participants. The baseline assessment was typically performed at a separate visit. Some participants withdrew after consenting but before completing the baseline assessment, and their scores are included.
|
13.8 units on a scale
STANDARD_DEVIATION 6.9 • n=43 Participants • The MOCA was administered immediately after obtaining informed consent and was missing for 2 participants. The baseline assessment was typically performed at a separate visit. Some participants withdrew after consenting but before completing the baseline assessment, and their scores are included.
|
12.3 units on a scale
STANDARD_DEVIATION 7.2 • n=86 Participants • The MOCA was administered immediately after obtaining informed consent and was missing for 2 participants. The baseline assessment was typically performed at a separate visit. Some participants withdrew after consenting but before completing the baseline assessment, and their scores are included.
|
PRIMARY outcome
Timeframe: 4 monthsThe Quality of Life Scale in Alzheimer's Disease (QOL-AD) is a standard quality of life measure that asks parallel questions of affected individuals and caregivers. Current quality of life is rated as poor (1 point), fair (2 points), good (3 points) or excellent (4 points) in 13 areas: physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores around the house, ability to do things for fun, money, and life as a whole. Scores may range from 13 to 52 with higher scores reflecting better quality of life. Prior studies have found that the QOL-AD is a valid and reliable measure, with Cronbach's alpha of 0.84 for patient reports and 0.86 for caregiver reports and interrater reliability based on Cohen's kappa values \>0.70.
Outcome measures
| Measure |
Immediate Start
n=42 Participants
The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
|
Delayed Start
n=43 Participants
Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
|
|---|---|---|
|
Quality of Life Scale in Alzheimer's Disease (QOL-AD)
|
38.8 score on a scale
Standard Deviation 6.2
|
40.0 score on a scale
Standard Deviation 4.3
|
PRIMARY outcome
Timeframe: 4 monthsThe SPPB was developed by the National Institute on Aging to provide an objective tool for measuring physical performance in older adults. Lower body strength is assessed based on time to complete 5 chair stands without using arms. Balance is assessed based on the ability to hold different stands for 10 seconds, including the side-by-side, semi-tandem and full tandem stands. Mobility is assessed based on usual walking speed over a 3-meter walking course. The total SPPB score is the sum of the 3 component scores and may range from 0 to 12. Higher scores reflect better performance.
Outcome measures
| Measure |
Immediate Start
n=42 Participants
The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
|
Delayed Start
n=43 Participants
Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
|
|---|---|---|
|
Short Physical Performance Battery (SPPB)-Modified
|
6.1 score on a scale
Standard Deviation 3.0
|
6.1 score on a scale
Standard Deviation 3.2
|
PRIMARY outcome
Timeframe: 4 monthsThe Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) is one of the most commonly used outcome measures in dementia drug treatment trials and is one of the measures considered by the Food and Drug Administration for approval of dementia medications. It includes direct assessment of learning (10-word list), naming (objects), following commands, constructional praxis (figure copying), ideational praxis (mailing a letter), orientation (person, time, place), recognition memory and remembering test instructions. Scores may range from 0 to 70 with higher scores reflecting worse cognitive function. Prior studies have found the ADAS-cog to be valid and reliable with Cronbach's alpha greater than 0.8 and test-retest reliability above 0.9.
Outcome measures
| Measure |
Immediate Start
n=42 Participants
The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
|
Delayed Start
n=43 Participants
Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
|
|---|---|---|
|
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog)
|
36.7 score on a scale
Standard Deviation 13.8
|
30.4 score on a scale
Standard Deviation 13.2
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Data missing for 1 immediate start participant (did not have a caregiver) and 1 delayed start participant (did not have a caregiver).
The Caregiver Burden Inventory (CBI) is a standard measure that includes 24 items and 5 domains. Caregivers are asked to rate how often each statement describes their feelings (never, rarely, sometimes, quite frequently, nearly always). The total score may range from 0 to 96 with higher scores reflecting greater feelings of burden.
Outcome measures
| Measure |
Immediate Start
n=41 Participants
The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
|
Delayed Start
n=42 Participants
Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
|
|---|---|---|
|
Caregiver Burden Inventory (CBI)
|
31.8 score on a scale
Standard Deviation 14.9
|
32.0 score on a scale
Standard Deviation 14.9
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Baseline data missing for 2 immediate start participants (1 did not have a caregiver, 1 caregiver did not complete questionnaire) and 1 delayed start participant (did not have a caregiver).
The Disability Assessment for Dementia (DAD) is a standard measure of functional independence that asks caregivers whether the participant performed 17 basic and 23 instrumental activities of daily living over the past 2 weeks without reminder or assistance. Each item is rated as yes, no, or not applicable (i.e., never performed, no opportunity to perform). The score reflects the percent of items performed independently, excluding those that were not applicable. Therefore, scores may range from 0 to 100 with higher scores reflecting greater independence. The DAD has high established validity and high test-retest reliability (ICC, 0.96), inter-rater reliability (ICC, 0.95) and internal consistency (Cronbach's alpha, 0.96).
Outcome measures
| Measure |
Immediate Start
n=40 Participants
The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
|
Delayed Start
n=42 Participants
Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
|
|---|---|---|
|
Disability Assessment for Dementia (DAD)
|
52.3 score on a scale
Standard Deviation 24.1
|
65.5 score on a scale
Standard Deviation 23.9
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Data missing for 1 immediate start participant (did not have a caregiver) and 1 delayed start participant (did not have a caregiver).
The NPI assesses the frequency, severity and level of distress caused by 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and appetite/eating). The NPI-N counts the number of symptoms present. Scores may range from 0 to 12 with higher scores reflecting worse outcomes (i.e., more symptoms).
Outcome measures
| Measure |
Immediate Start
n=41 Participants
The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
|
Delayed Start
n=42 Participants
Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
|
|---|---|---|
|
Neuropsychiatric Inventory - Number (NPI-N)
|
4.0 score on a scale
Standard Deviation 2.8
|
3.5 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Data missing for 1 immediate start participant (did not have a caregiver) and 1 delayed start participant (did not have a caregiver).
The Neuropsychiatric Inventory - Frequency\*Severity subscale (NPI-FS) assesses the frequency and severity of 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and appetite/eating) by caregiver report. NPI-FS was calculated by multiplying the frequency\*severity of behaviors, which had a range of 0-144. Higher scores indicate worse outcomes (greater frequency/severity).
Outcome measures
| Measure |
Immediate Start
n=41 Participants
The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
|
Delayed Start
n=42 Participants
Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
|
|---|---|---|
|
Neuropsychiatric Inventory - Frequency*Severity (NPI-FS)
|
15.9 score on a scale
Standard Deviation 18.4
|
14.1 score on a scale
Standard Deviation 15.9
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Data missing for 1 immediate start participant (did not have a caregiver) and 1 delayed start participant (did not have a caregiver).
Measure of caregiver distress associated with 12 common dementia-related behaviors. Scores may range from 0 to 60 with higher scores reflecting greater distress.
Outcome measures
| Measure |
Immediate Start
n=41 Participants
The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
|
Delayed Start
n=42 Participants
Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
|
|---|---|---|
|
Neuropsychiatric Inventory - Caregiver Distress
|
8.1 score on a scale
Standard Deviation 8.4
|
8.3 score on a scale
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Data missing for 1 immediate start participant (did not have a caregiver) and 1 delayed start participant (did not have a caregiver).
Caregiver assessment of participant's quality of life. Scores may range from 13 to 52, with higher scores reflecting better quality of life.
Outcome measures
| Measure |
Immediate Start
n=41 Participants
The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
|
Delayed Start
n=42 Participants
Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
|
|---|---|---|
|
Quality of Life in Alzheimer's Disease - CG Report About Participant
|
31.2 score on a scale
Standard Deviation 5.6
|
33.1 score on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Data missing for 2 immediate start participants (1 did not have a caregiver, 1 did not complete questionnaire) and 1 delayed start participant (did not have a caregiver).
Depressive symptoms were assessed in caregivers based on self-report using the GDS - short form, a 15-item yes/no scale. Scores may range from 0 to 15, with higher scores reflecting greater depressive symptomatology.
Outcome measures
| Measure |
Immediate Start
n=40 Participants
The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
|
Delayed Start
n=42 Participants
Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
|
|---|---|---|
|
Geriatric Depression Scale (GDS)
|
3.3 score on a scale
Standard Deviation 3.2
|
3.3 score on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Data missing for 1 immediate start participant (did not have a caregiver) and 1 delayed start participant (did not have a caregiver).
A standard measure that asks caregivers to rate their agreement/disagreement with 11 statements about positive aspects of caregiving on a 5-point likert scale (disagree a lot ... agree a lot). Total scores range from 11 to 55 with higher scores indicating more positive feelings
Outcome measures
| Measure |
Immediate Start
n=41 Participants
The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
|
Delayed Start
n=42 Participants
Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
|
|---|---|---|
|
Positive Aspects of Caregiving (PAC)
|
36.9 score on a scale
Standard Deviation 8.2
|
39.5 score on a scale
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Data missing for 10 immediate start and 13 delayed start participants (unable to complete test)
Time to complete 5 chair stands without using arms in seconds. Higher scores reflect worse (slower) performance.
Outcome measures
| Measure |
Immediate Start
n=32 Participants
The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
|
Delayed Start
n=30 Participants
Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
|
|---|---|---|
|
Chair Stand Time
|
17.7 seconds
Standard Deviation 8.4
|
18.2 seconds
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: 4 monthsFrom Short Physical Performance Battery, including side-by-side, semi-tandem, and tandem balance. Score may range from 0 to 4, with higher scores indicating better balance.
Outcome measures
| Measure |
Immediate Start
n=42 Participants
The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
|
Delayed Start
n=43 Participants
Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
|
|---|---|---|
|
Balance Score
|
2.4 score on a scale
Standard Deviation 1.4
|
2.4 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Data missing for 1 delayed start participant (unable to complete test).
From Short Physical Performance Battery, better of two times in seconds. Higher scores reflect worse (slower) performance.
Outcome measures
| Measure |
Immediate Start
n=42 Participants
The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
|
Delayed Start
n=42 Participants
Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
|
|---|---|---|
|
Usual Gait Speed
|
5.6 seconds
Standard Deviation 3.9
|
5.6 seconds
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Data missing for 2 immediate start and 3 delayed start participants (unable to complete test).
Measure of mobility in which participant is timed while standing up from a seated position, walking around a cone that is 8 feet away, and returning to a seated position. Higher scores reflect worse (slower) performance.
Outcome measures
| Measure |
Immediate Start
n=40 Participants
The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
|
Delayed Start
n=40 Participants
Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
|
|---|---|---|
|
Timed Up & Go
|
15.7 seconds
Standard Deviation 10.8
|
16.1 seconds
Standard Deviation 18.1
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Data missing for 3 immediate start and 2 delayed start participants (unable to complete test).
Measure of flexibility in which participant reaches toward toes with a straight leg. Score reflect closest to touching, with positive values reflecting past toes and negative values reflecting not touching toes.
Outcome measures
| Measure |
Immediate Start
n=39 Participants
The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
|
Delayed Start
n=41 Participants
Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
|
|---|---|---|
|
Sit & Reach
|
-4.3 inches
Standard Deviation 5.0
|
-4.0 inches
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: Data missing for 1 immediate start and 1 delayed start participants (unable to answer questions).
A standard measure of falls efficacy that can be administered to people with cognitive impairment or caregivers and asks about concern about the possibility of falling doing 10 daily tasks (e.g., taking a bath or shower) on a 4-point likert scale (not at all, somewhat, fairly or very concerned). Scores may range from 10 to 40 with higher scores reflecting worse outcomes (i.e., greater concern about falling).
Outcome measures
| Measure |
Immediate Start
n=41 Participants
The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
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Delayed Start
n=42 Participants
Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
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|---|---|---|
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Falls Efficacy Scale (FES) - Participant Report
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14.2 score on a scale
Standard Deviation 6.7
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14.1 score on a scale
Standard Deviation 5.3
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POST_HOC outcome
Timeframe: 8 monthsPopulation: 47 of 88 (53%) caregivers returned the survey
Caregivers were sent an anonymous satisfaction survey after completion or withdrawal with a pre-paid return envelope. Satisfaction was rated on a 5-point Likert scale (1=Highly Unsatisfied to 5=Highly Satisfied). Open-ended questions asked about changes observed in study participants and themselves when participating in the program, what they liked the most and found most challenging, and other comments. Qualitative content analyses were performed to identify key domains and sub-domains described.
Outcome measures
| Measure |
Immediate Start
n=47 Participants
The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
|
Delayed Start
Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
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|---|---|---|
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Satisfaction Score
|
4.5 score on a scale
Standard Deviation 0.9
|
—
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Adverse Events
Immediate Start
Delayed Start
Serious adverse events
| Measure |
Immediate Start
n=44 participants at risk
The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
|
Delayed Start
n=44 participants at risk
Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
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|---|---|---|
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General disorders
Hospitalization
|
13.6%
6/44 • Number of events 7 • 8 months
Adverse events were collected systematically in both groups during monthly check-in calls by asking caregivers whether study participants had experienced any major health-related events since the last contact. In addition, research staff logged adverse events that they learned about during other interactions with study participants. Adverse events were classified as serious (death, hospitalization, persistent disability, life-threatening) or not serious and were not classified by organ system.
|
18.2%
8/44 • Number of events 10 • 8 months
Adverse events were collected systematically in both groups during monthly check-in calls by asking caregivers whether study participants had experienced any major health-related events since the last contact. In addition, research staff logged adverse events that they learned about during other interactions with study participants. Adverse events were classified as serious (death, hospitalization, persistent disability, life-threatening) or not serious and were not classified by organ system.
|
|
General disorders
Life-threatening
|
4.5%
2/44 • Number of events 2 • 8 months
Adverse events were collected systematically in both groups during monthly check-in calls by asking caregivers whether study participants had experienced any major health-related events since the last contact. In addition, research staff logged adverse events that they learned about during other interactions with study participants. Adverse events were classified as serious (death, hospitalization, persistent disability, life-threatening) or not serious and were not classified by organ system.
|
4.5%
2/44 • Number of events 2 • 8 months
Adverse events were collected systematically in both groups during monthly check-in calls by asking caregivers whether study participants had experienced any major health-related events since the last contact. In addition, research staff logged adverse events that they learned about during other interactions with study participants. Adverse events were classified as serious (death, hospitalization, persistent disability, life-threatening) or not serious and were not classified by organ system.
|
Other adverse events
| Measure |
Immediate Start
n=44 participants at risk
The Immediate Start group will participate in the Preventing Loss of Independence through Exercise (PLIE) group movement program for 1 hour, 2-3 days/week, for 4 months. After the intervention has been completed, they will be encouraged to maintain PLIE activities on their own for the next 4 months.
|
Delayed Start
n=44 participants at risk
Study participants who are randomized to the Delayed Start control group will be placed on a waitlist and will be encouraged to continue participating in their usual activities at the adult day center or in their community setting for 4 months. After the 4-month waitlist period ends, they will participate in the PLIE program for 1 hour, 2-3 days/week, for 4 months.
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|---|---|---|
|
General disorders
Not serious
|
34.1%
15/44 • Number of events 30 • 8 months
Adverse events were collected systematically in both groups during monthly check-in calls by asking caregivers whether study participants had experienced any major health-related events since the last contact. In addition, research staff logged adverse events that they learned about during other interactions with study participants. Adverse events were classified as serious (death, hospitalization, persistent disability, life-threatening) or not serious and were not classified by organ system.
|
22.7%
10/44 • Number of events 21 • 8 months
Adverse events were collected systematically in both groups during monthly check-in calls by asking caregivers whether study participants had experienced any major health-related events since the last contact. In addition, research staff logged adverse events that they learned about during other interactions with study participants. Adverse events were classified as serious (death, hospitalization, persistent disability, life-threatening) or not serious and were not classified by organ system.
|
|
General disorders
Other AE
|
15.9%
7/44 • Number of events 8 • 8 months
Adverse events were collected systematically in both groups during monthly check-in calls by asking caregivers whether study participants had experienced any major health-related events since the last contact. In addition, research staff logged adverse events that they learned about during other interactions with study participants. Adverse events were classified as serious (death, hospitalization, persistent disability, life-threatening) or not serious and were not classified by organ system.
|
4.5%
2/44 • Number of events 3 • 8 months
Adverse events were collected systematically in both groups during monthly check-in calls by asking caregivers whether study participants had experienced any major health-related events since the last contact. In addition, research staff logged adverse events that they learned about during other interactions with study participants. Adverse events were classified as serious (death, hospitalization, persistent disability, life-threatening) or not serious and were not classified by organ system.
|
|
General disorders
Procedures
|
2.3%
1/44 • Number of events 1 • 8 months
Adverse events were collected systematically in both groups during monthly check-in calls by asking caregivers whether study participants had experienced any major health-related events since the last contact. In addition, research staff logged adverse events that they learned about during other interactions with study participants. Adverse events were classified as serious (death, hospitalization, persistent disability, life-threatening) or not serious and were not classified by organ system.
|
0.00%
0/44 • 8 months
Adverse events were collected systematically in both groups during monthly check-in calls by asking caregivers whether study participants had experienced any major health-related events since the last contact. In addition, research staff logged adverse events that they learned about during other interactions with study participants. Adverse events were classified as serious (death, hospitalization, persistent disability, life-threatening) or not serious and were not classified by organ system.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place