Trial Outcomes & Findings for Moving Together: An Online Group Movement Program for People Living With Memory Loss and Caregivers (NCT NCT04621448)
NCT ID: NCT04621448
Last Updated: 2025-04-22
Results Overview
The QOL-AD is a standard quality of life measure that has been validated for people with cognitive impairment. Scores may range from 0-52, with higher scores reflecting better quality of life.
COMPLETED
NA
224 participants
Baseline to 12-weeks
2025-04-22
Participant Flow
Study participants are enrolled as dyads of persons living with dementia (PLWD) and care partners (CPs).
Participant milestones
| Measure |
Waitlist Control - PLWD
Usual activities for 12 weeks followed by Moving Together classes (1 hour, 2 days/week) for 12 weeks for PLWD.
|
Moving Together - PLWD
Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by optional continuation of classes for 12 weeks for PLWD.
|
Waitlist Control - CP
Usual activities for 12 weeks followed by Moving Together classes for 12 weeks (1 hour, 2 days/week) for CPs.
|
Moving Together - CP
Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by optional continuation of classes for 12 weeks for CPs.
|
|---|---|---|---|---|
|
Baseline to 12 Weeks
STARTED
|
43
|
54
|
43
|
54
|
|
Baseline to 12 Weeks
COMPLETED
|
37
|
45
|
37
|
45
|
|
Baseline to 12 Weeks
NOT COMPLETED
|
6
|
9
|
6
|
9
|
|
12 to 24 Weeks
STARTED
|
37
|
45
|
37
|
45
|
|
12 to 24 Weeks
COMPLETED
|
33
|
43
|
33
|
43
|
|
12 to 24 Weeks
NOT COMPLETED
|
4
|
2
|
4
|
2
|
Reasons for withdrawal
| Measure |
Waitlist Control - PLWD
Usual activities for 12 weeks followed by Moving Together classes (1 hour, 2 days/week) for 12 weeks for PLWD.
|
Moving Together - PLWD
Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by optional continuation of classes for 12 weeks for PLWD.
|
Waitlist Control - CP
Usual activities for 12 weeks followed by Moving Together classes for 12 weeks (1 hour, 2 days/week) for CPs.
|
Moving Together - CP
Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by optional continuation of classes for 12 weeks for CPs.
|
|---|---|---|---|---|
|
Baseline to 12 Weeks
Withdrawal by Subject
|
6
|
8
|
6
|
8
|
|
Baseline to 12 Weeks
Lost to Follow-up
|
0
|
1
|
0
|
1
|
|
12 to 24 Weeks
Lost to Follow-up
|
1
|
0
|
1
|
0
|
|
12 to 24 Weeks
Withdrawal by Subject
|
3
|
2
|
3
|
2
|
Baseline Characteristics
There are separate rows for PLWD and CPs.
Baseline characteristics by cohort
| Measure |
Waitlist Control
n=86 Participants
Usual activities for 12 weeks followed by Moving Together classes (1 hour, 2 days/week) for 12 weeks.
|
Moving Together
n=108 Participants
Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by return to usual activities for 12 weeks.
|
Total
n=194 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Participants with dementia
|
76.8 years
STANDARD_DEVIATION 9.7 • n=43 Participants • There are separate rows for PLWD and CPs.
|
76.2 years
STANDARD_DEVIATION 11.3 • n=54 Participants • There are separate rows for PLWD and CPs.
|
76.4 years
STANDARD_DEVIATION 10.6 • n=97 Participants • There are separate rows for PLWD and CPs.
|
|
Age, Continuous
Care partners
|
68.9 years
STANDARD_DEVIATION 11.0 • n=43 Participants • There are separate rows for PLWD and CPs.
|
63.3 years
STANDARD_DEVIATION 11.8 • n=54 Participants • There are separate rows for PLWD and CPs.
|
65.8 years
STANDARD_DEVIATION 11.7 • n=97 Participants • There are separate rows for PLWD and CPs.
|
|
Sex: Female, Male
Participants with dementia · Female
|
21 Participants
n=43 Participants • There are separate rows for PLWD and CPs.
|
21 Participants
n=54 Participants • There are separate rows for PLWD and CPs.
|
42 Participants
n=97 Participants • There are separate rows for PLWD and CPs.
|
|
Sex: Female, Male
Participants with dementia · Male
|
22 Participants
n=43 Participants • There are separate rows for PLWD and CPs.
|
33 Participants
n=54 Participants • There are separate rows for PLWD and CPs.
|
55 Participants
n=97 Participants • There are separate rows for PLWD and CPs.
|
|
Sex: Female, Male
Care partners · Female
|
32 Participants
n=43 Participants • There are separate rows for PLWD and CPs.
|
44 Participants
n=54 Participants • There are separate rows for PLWD and CPs.
|
76 Participants
n=97 Participants • There are separate rows for PLWD and CPs.
|
|
Sex: Female, Male
Care partners · Male
|
11 Participants
n=43 Participants • There are separate rows for PLWD and CPs.
|
10 Participants
n=54 Participants • There are separate rows for PLWD and CPs.
|
21 Participants
n=97 Participants • There are separate rows for PLWD and CPs.
|
|
Race/Ethnicity, Customized
Participants with dementia · Asian
|
3 Participants
n=43 Participants • There are separate rows for PLWD and CPs.
|
5 Participants
n=54 Participants • There are separate rows for PLWD and CPs.
|
8 Participants
n=97 Participants • There are separate rows for PLWD and CPs.
|
|
Race/Ethnicity, Customized
Participants with dementia · Black or African American
|
1 Participants
n=43 Participants • There are separate rows for PLWD and CPs.
|
4 Participants
n=54 Participants • There are separate rows for PLWD and CPs.
|
5 Participants
n=97 Participants • There are separate rows for PLWD and CPs.
|
|
Race/Ethnicity, Customized
Participants with dementia · Hispanic/Latino/a/x (any race)
|
2 Participants
n=43 Participants • There are separate rows for PLWD and CPs.
|
1 Participants
n=54 Participants • There are separate rows for PLWD and CPs.
|
3 Participants
n=97 Participants • There are separate rows for PLWD and CPs.
|
|
Race/Ethnicity, Customized
Participants with dementia · Non-Hispanic White
|
36 Participants
n=43 Participants • There are separate rows for PLWD and CPs.
|
42 Participants
n=54 Participants • There are separate rows for PLWD and CPs.
|
78 Participants
n=97 Participants • There are separate rows for PLWD and CPs.
|
|
Race/Ethnicity, Customized
Participants with dementia · Other/unknown race/ethnicity
|
1 Participants
n=43 Participants • There are separate rows for PLWD and CPs.
|
2 Participants
n=54 Participants • There are separate rows for PLWD and CPs.
|
3 Participants
n=97 Participants • There are separate rows for PLWD and CPs.
|
|
Race/Ethnicity, Customized
Care partners · Asian
|
5 Participants
n=43 Participants • There are separate rows for PLWD and CPs.
|
9 Participants
n=54 Participants • There are separate rows for PLWD and CPs.
|
14 Participants
n=97 Participants • There are separate rows for PLWD and CPs.
|
|
Race/Ethnicity, Customized
Care partners · Black or African American
|
0 Participants
n=43 Participants • There are separate rows for PLWD and CPs.
|
5 Participants
n=54 Participants • There are separate rows for PLWD and CPs.
|
5 Participants
n=97 Participants • There are separate rows for PLWD and CPs.
|
|
Race/Ethnicity, Customized
Care partners · Hispanic/Latino/a/x (any race)
|
4 Participants
n=43 Participants • There are separate rows for PLWD and CPs.
|
1 Participants
n=54 Participants • There are separate rows for PLWD and CPs.
|
5 Participants
n=97 Participants • There are separate rows for PLWD and CPs.
|
|
Race/Ethnicity, Customized
Care partners · Non-Hispanic White
|
33 Participants
n=43 Participants • There are separate rows for PLWD and CPs.
|
36 Participants
n=54 Participants • There are separate rows for PLWD and CPs.
|
69 Participants
n=97 Participants • There are separate rows for PLWD and CPs.
|
|
Race/Ethnicity, Customized
Care partners · Other/unknown race/ethnicity
|
1 Participants
n=43 Participants • There are separate rows for PLWD and CPs.
|
3 Participants
n=54 Participants • There are separate rows for PLWD and CPs.
|
4 Participants
n=97 Participants • There are separate rows for PLWD and CPs.
|
|
Education
Participants with dementia
|
16.2 years
STANDARD_DEVIATION 3.1 • n=43 Participants • Separate rows are provided for PLWD and CPs
|
16.8 years
STANDARD_DEVIATION 2.8 • n=54 Participants • Separate rows are provided for PLWD and CPs
|
16.5 years
STANDARD_DEVIATION 3.0 • n=97 Participants • Separate rows are provided for PLWD and CPs
|
|
Education
Care partners
|
17.0 years
STANDARD_DEVIATION 3.2 • n=43 Participants • Separate rows are provided for PLWD and CPs
|
16.7 years
STANDARD_DEVIATION 2.8 • n=54 Participants • Separate rows are provided for PLWD and CPs
|
16.8 years
STANDARD_DEVIATION 3.0 • n=97 Participants • Separate rows are provided for PLWD and CPs
|
|
Dementia Diagnosis
Alzheimer's disease
|
12 Participants
n=43 Participants • Measure only collected for PLWD
|
17 Participants
n=54 Participants • Measure only collected for PLWD
|
29 Participants
n=97 Participants • Measure only collected for PLWD
|
|
Dementia Diagnosis
Dementia unspecified
|
4 Participants
n=43 Participants • Measure only collected for PLWD
|
15 Participants
n=54 Participants • Measure only collected for PLWD
|
19 Participants
n=97 Participants • Measure only collected for PLWD
|
|
Dementia Diagnosis
Mild cognitive impairment
|
7 Participants
n=43 Participants • Measure only collected for PLWD
|
6 Participants
n=54 Participants • Measure only collected for PLWD
|
13 Participants
n=97 Participants • Measure only collected for PLWD
|
|
Dementia Diagnosis
Mixed dementia
|
4 Participants
n=43 Participants • Measure only collected for PLWD
|
1 Participants
n=54 Participants • Measure only collected for PLWD
|
5 Participants
n=97 Participants • Measure only collected for PLWD
|
|
Dementia Diagnosis
Vascular dementia
|
5 Participants
n=43 Participants • Measure only collected for PLWD
|
5 Participants
n=54 Participants • Measure only collected for PLWD
|
10 Participants
n=97 Participants • Measure only collected for PLWD
|
|
Dementia Diagnosis
Other/unknown type of dementia
|
11 Participants
n=43 Participants • Measure only collected for PLWD
|
10 Participants
n=54 Participants • Measure only collected for PLWD
|
21 Participants
n=97 Participants • Measure only collected for PLWD
|
|
Quick Dementia Rating System (QDRS)
|
7.5 points on a scale
STANDARD_DEVIATION 2.9 • n=43 Participants • Measure only relevant for PLWD.
|
7.8 points on a scale
STANDARD_DEVIATION 2.3 • n=54 Participants • Measure only relevant for PLWD.
|
7.7 points on a scale
STANDARD_DEVIATION 3.0 • n=97 Participants • Measure only relevant for PLWD.
|
|
Relationship to PLWD
Spouse or partner
|
31 Participants
n=43 Participants • Only relevant for CPs
|
34 Participants
n=54 Participants • Only relevant for CPs
|
65 Participants
n=97 Participants • Only relevant for CPs
|
|
Relationship to PLWD
Child or child-in-law
|
9 Participants
n=43 Participants • Only relevant for CPs
|
15 Participants
n=54 Participants • Only relevant for CPs
|
24 Participants
n=97 Participants • Only relevant for CPs
|
|
Relationship to PLWD
Paid
|
1 Participants
n=43 Participants • Only relevant for CPs
|
3 Participants
n=54 Participants • Only relevant for CPs
|
4 Participants
n=97 Participants • Only relevant for CPs
|
|
Relationship to PLWD
Other relationship
|
2 Participants
n=43 Participants • Only relevant for CPs
|
2 Participants
n=54 Participants • Only relevant for CPs
|
4 Participants
n=97 Participants • Only relevant for CPs
|
PRIMARY outcome
Timeframe: Baseline to 12-weeksPopulation: Only measured in PLWD. Baseline data missing for 1 participant in the Moving Together group.
The QOL-AD is a standard quality of life measure that has been validated for people with cognitive impairment. Scores may range from 0-52, with higher scores reflecting better quality of life.
Outcome measures
| Measure |
Waitlist Control - PLWD
n=43 Participants
Usual activities for 12 weeks followed by Moving Together classes (1 hour, 2 days/week) for 12 weeks.
|
Moving Together - PLWD
n=53 Participants
Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by return to usual activities for 12 weeks.
|
|---|---|---|
|
Quality of Life - Change (Quality of Life in Alzheimer's Disease Scale, QOL-AD)
|
-1.7 score on a scale
Standard Deviation 0.6
|
0.7 score on a scale
Standard Deviation 4.2
|
PRIMARY outcome
Timeframe: Baseline to 12-weeksPopulation: Measured only in CPs.
The Short Form Health Survey (SF-12) is a 12-item questionnaire that was developed as a shorter alternative to the SF-36 Health Survey (SF-36). It consists of a subset of 12 items from the SF-36 covering the same eight domains of health outcomes and generates two summary scores: the Physical and Mental Health Composite Scores (PCS, MCS). Scores may range from 0-100, with higher scores reflecting better levels of health.
Outcome measures
| Measure |
Waitlist Control - PLWD
n=54 Participants
Usual activities for 12 weeks followed by Moving Together classes (1 hour, 2 days/week) for 12 weeks.
|
Moving Together - PLWD
n=43 Participants
Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by return to usual activities for 12 weeks.
|
|---|---|---|
|
Caregiver Physical Health - Change (Short Form Health Survey [SF-12] Physical Composite Score [PCS])
|
0.2 score on a scale
Standard Deviation 8.0
|
-0.6 score on a scale
Standard Deviation 7.7
|
PRIMARY outcome
Timeframe: Baseline to 12 weeksPopulation: Only measured in CPs.
The Short Form Health Survey (SF-12) is a 12-item questionnaire that was developed as a shorter alternative to the SF-36 Health Survey (SF-36). It consists of a subset of 12 items from the SF-36 covering the same eight domains of health outcomes and generates two summary scores: the Physical and Mental Health Composite Scores (PCS, MCS). Scores may range from 0-100, with higher scores reflecting better levels of health.
Outcome measures
| Measure |
Waitlist Control - PLWD
n=43 Participants
Usual activities for 12 weeks followed by Moving Together classes (1 hour, 2 days/week) for 12 weeks.
|
Moving Together - PLWD
n=54 Participants
Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by return to usual activities for 12 weeks.
|
|---|---|---|
|
Caregiver Mental Health - Change (Short Form - 12 [SF-12] Mental Composite Score [MCS])
|
-0.7 score on a scale
Standard Deviation 7.9
|
0.0 score on a scale
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: Baseline to 12-weeksPopulation: Only measured in PLWD. Data missing for 1 participant.
The Neuro-QOL v1.0 Positive Affect and Well-Being Short Form includes 9 items (e.g. sense of well-being, feeling hopeful, life was satisfying, etc.) with 5-point responses from never (1) to always (5). Scores range from 0-40 with higher scores indicating increased mobility.
Outcome measures
| Measure |
Waitlist Control - PLWD
n=43 Participants
Usual activities for 12 weeks followed by Moving Together classes (1 hour, 2 days/week) for 12 weeks.
|
Moving Together - PLWD
n=53 Participants
Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by return to usual activities for 12 weeks.
|
|---|---|---|
|
Well-being - Change (Neuro-QOL v1.0 Positive Affect and Well-Being Short Form)
|
-1.7 score on a scale
Standard Deviation 6.1
|
0.1 score on a scale
Standard Deviation 4.0
|
SECONDARY outcome
Timeframe: Baseline to 12-weeksPopulation: Measured in PLWD. Data missing for 1 participant.
The Patient-Reported Outcomes Measurement Information System v2.0 social isolation scale consists of 4 items (feeling left out, people barely know me, feeling isolated, people are around but not with me) that are rated as 1 (never), 2 (rarely), 3 (sometimes), 4 (usually), or 5 (always). Scores range from 0-20 with higher scores indicating less perceived social isolation.
Outcome measures
| Measure |
Waitlist Control - PLWD
n=43 Participants
Usual activities for 12 weeks followed by Moving Together classes (1 hour, 2 days/week) for 12 weeks.
|
Moving Together - PLWD
n=53 Participants
Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by return to usual activities for 12 weeks.
|
|---|---|---|
|
Social Isolation - Change (Patient-Reported Outcomes Measurement Information System v2.0 Social Isolation Scale)
|
-0.2 score on a scale
Standard Deviation 3.6
|
-0.5 score on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Baseline to 12-weeksPopulation: Measure applies to PLWD. Data missing for 1 Moving Together participant.
The (Neuro-QOL Short Form v1.0 -- Lower Extremity Function -- Mobility), which includes 8 items for functional mobility (getting on and off the toilet, getting in and out of a car, getting out of bed into a chair). Responses are rated on a 5-point Likert scale: 1( Without any difficult), 2 (With a little difficulty), 3 (With some difficulty), 4 (With much difficulty), 5 (Unable to do). Scores may range from 0-40 with higher scores indicating increased mobility.
Outcome measures
| Measure |
Waitlist Control - PLWD
n=43 Participants
Usual activities for 12 weeks followed by Moving Together classes (1 hour, 2 days/week) for 12 weeks.
|
Moving Together - PLWD
n=53 Participants
Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by return to usual activities for 12 weeks.
|
|---|---|---|
|
Mobility - Change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility)
|
-1.6 score on a scale
Standard Deviation 5.0
|
0.3 score on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Baseline to 12-weeksPopulation: Measured only in PLWD. Data missing for 1 Moving Together participant.
The t-MoCA is extracted from the original face-to-face MoCA and uses items not requiring the use of a pencil and paper or visual stimulus. Scores may range from 0-22 with higher scores indicating higher cognitive function.
Outcome measures
| Measure |
Waitlist Control - PLWD
n=43 Participants
Usual activities for 12 weeks followed by Moving Together classes (1 hour, 2 days/week) for 12 weeks.
|
Moving Together - PLWD
n=53 Participants
Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by return to usual activities for 12 weeks.
|
|---|---|---|
|
Cognitive Function - Change (Telephone Montreal Cognitive Assessment, t-MoCA)
|
-0.8 score on a scale
Standard Deviation 3.3
|
-0.5 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline to 12-weeksPopulation: Measure applies to CPs only.
The Healthy Days Core Modules includes 3 questions about the number of days during the past 30 days that physical or mental health was not good or poor physical or mental health kept from doing usual activities. Scores range from 0-18 with lower scores indicating higher physical or mental health.
Outcome measures
| Measure |
Waitlist Control - PLWD
n=43 Participants
Usual activities for 12 weeks followed by Moving Together classes (1 hour, 2 days/week) for 12 weeks.
|
Moving Together - PLWD
n=54 Participants
Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by return to usual activities for 12 weeks.
|
|---|---|---|
|
Caregiver Healthy Days - Change (Healthy Days Core Module)
|
0.0 score on a scale
Standard Deviation 2.5
|
0.5 score on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Baseline to 12-weeksPopulation: Measure applies to CPs only.
The GAIN consists of 10-items (e.g., increased my self-awareness, increased my knowledge and skills in dementia care) using a Likert scale from 0 (disagree a lot) to 4 (agree a lot). Scores range from 0 to 40 with higher scores indicating increased positive feelings about caregiving
Outcome measures
| Measure |
Waitlist Control - PLWD
n=43 Participants
Usual activities for 12 weeks followed by Moving Together classes (1 hour, 2 days/week) for 12 weeks.
|
Moving Together - PLWD
n=54 Participants
Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by return to usual activities for 12 weeks.
|
|---|---|---|
|
Caregiver Self-efficacy - Change (Gain in Alzheimer Care INstrument (GAIN))
|
0.1 score on a scale
Standard Deviation 5.0
|
0.5 score on a scale
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: Baseline to 12-weeksPopulation: Measure applies to CPs only.
The Zarit Burden Interview is one of the most widely used assessments for caregiver burden covering areas including caregiver's health, psychological well-being, finances, social life, and the relationship between the caregiver and the person with dementia. Scores range from 0-24 with higher scores indicating positive caregiver experience.
Outcome measures
| Measure |
Waitlist Control - PLWD
n=43 Participants
Usual activities for 12 weeks followed by Moving Together classes (1 hour, 2 days/week) for 12 weeks.
|
Moving Together - PLWD
n=54 Participants
Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by return to usual activities for 12 weeks.
|
|---|---|---|
|
Caregiver Burden - Change (Zarit Burden Interview, 6-item Version)
|
-0.2 score on a scale
Standard Deviation 3.1
|
0.4 score on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Baseline to 12-weeksPopulation: Measure applies to CPs only.
The Patient-Reported Outcomes Measurement Information System v2.0 social isolation scale consists of 4 items (feeling left out, people barely know me, feeling isolated, people are around but not with me) that are rated as 1 (never), 2 (rarely), 3 (sometimes), 4 (usually), or 5 (always). Scores range from 0-20 with higher scores indicating less perceived social isolation.
Outcome measures
| Measure |
Waitlist Control - PLWD
n=43 Participants
Usual activities for 12 weeks followed by Moving Together classes (1 hour, 2 days/week) for 12 weeks.
|
Moving Together - PLWD
n=54 Participants
Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by return to usual activities for 12 weeks.
|
|---|---|---|
|
Caregiver Social Isolation - Change (PROMIS v2.0 Social Isolation Scale)
|
0.3 score on a scale
Standard Deviation 2.3
|
-0.1 score on a scale
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Change from baseline to 12-weeksPopulation: Measure applies to CPs only.
The MAIA-2 - Self-regulation subscale is designed to assess ability to regulate distress by attention to body sensations (e.g., when I feel overwhelmed, I can find a calm place inside). Scores range from 0-20 with higher scores indicating increased self-regulation.
Outcome measures
| Measure |
Waitlist Control - PLWD
n=43 Participants
Usual activities for 12 weeks followed by Moving Together classes (1 hour, 2 days/week) for 12 weeks.
|
Moving Together - PLWD
n=54 Participants
Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by return to usual activities for 12 weeks.
|
|---|---|---|
|
Caregiver Self-regulation - Change (Abbreviated Multidimensional Assessment of Interoceptive Awareness-2 (MAIA) Self-regulation Subscale)
|
0.3 score on a scale
Standard Deviation 2.4
|
1.9 score on a scale
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Baseline to 12-weeksPopulation: Measure applies to CPs only.
The Positive States of Mind scale is designed to assess types of positive mood (e.g., focused attention, productivity, responsible caregiving, etc.). This scale consists of 6-items using a 4-point Likert scale from 0 (Unable to have it) to 3 (Have it Easily). Scores range from 0-18 with higher scores indicating positive mood.
Outcome measures
| Measure |
Waitlist Control - PLWD
n=43 Participants
Usual activities for 12 weeks followed by Moving Together classes (1 hour, 2 days/week) for 12 weeks.
|
Moving Together - PLWD
n=54 Participants
Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by return to usual activities for 12 weeks.
|
|---|---|---|
|
Caregiver Positive Affect (Positive States of Mind)
|
0.5 score on a scale
Standard Deviation 2.1
|
-0.3 score on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Baseline to 12-weeksPopulation: Measure only applies to CPs.
The Symptom Checklist-90-Revised is a 90-item self-report questionnaire often used to assess global psychological distress and the investigators will be using 3 items assessing: trouble falling asleep, awakening in the early morning, and sleep that is restless or disturbed. Scores range from 0-12 with lower scores indicating less sleep difficulties.
Outcome measures
| Measure |
Waitlist Control - PLWD
n=43 Participants
Usual activities for 12 weeks followed by Moving Together classes (1 hour, 2 days/week) for 12 weeks.
|
Moving Together - PLWD
n=54 Participants
Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by return to usual activities for 12 weeks.
|
|---|---|---|
|
Caregiver Sleep - Change (Symptom Checklist, 3 Items)
|
-0.1 score on a scale
Standard Deviation 1.9
|
0.2 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Baseline to 12-weeksPopulation: Measure only asked of CPs regarding PLWD.
Caregivers also will be asked about sleep for the PWML using the 3 sleep items from the Symptom Checklist-90-Revised (trouble falling asleep, awakening in the early morning, and sleep that is restless or disturbed). Scores range from 0-12 with lower scores indicating less sleep difficulties.
Outcome measures
| Measure |
Waitlist Control - PLWD
n=43 Participants
Usual activities for 12 weeks followed by Moving Together classes (1 hour, 2 days/week) for 12 weeks.
|
Moving Together - PLWD
n=54 Participants
Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by return to usual activities for 12 weeks.
|
|---|---|---|
|
People With Memory Loss (PWML) Sleep - Change (Symptom Checklist, 3 Items)
|
0.1 score on a scale
Standard Deviation 2.0
|
-0.3 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Baseline to 12-weeksPopulation: Measure asked of CPs regarding PLWD.
As described above, the Neuro-QOL Short Form v1.0 - Lower Extremity Function - Mobility includes 8 items for functional mobility (e.g. getting on and off the toilet, getting in and out of a car, getting out of bed into a chair, etc.). CGs will be asked about the mobility of the PWML. Scores range from 0-35 with higher scores indicating less physical difficulty with daily activities.
Outcome measures
| Measure |
Waitlist Control - PLWD
n=43 Participants
Usual activities for 12 weeks followed by Moving Together classes (1 hour, 2 days/week) for 12 weeks.
|
Moving Together - PLWD
n=54 Participants
Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by return to usual activities for 12 weeks.
|
|---|---|---|
|
People With Memory Loss (PWML) Mobility - Change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility)
|
-0.3 score on a scale
Standard Deviation 4.9
|
-0.2 score on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Baseline to 12-weeksPopulation: Measure asked CPs about PLWD.
The original Cognitive Function Instrument included 14 items that asked about decline in cognitive function (e.g., memory, tendency to repeat questions, misplacing things, etc.) compared to 1 year ago with responses of yes (1), no (0) or maybe (0.5). The investigators will be using a modified 11-item version that excludes items on driving, managing money, work; asking about change in the past 3 months (to match the duration of our study); and using a 5-point Likert scale from 1 (a lot worse) to 5 (a lot better). Scores range from 0-55 with higher scores indicating improved cognitive function.
Outcome measures
| Measure |
Waitlist Control - PLWD
n=43 Participants
Usual activities for 12 weeks followed by Moving Together classes (1 hour, 2 days/week) for 12 weeks.
|
Moving Together - PLWD
n=54 Participants
Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by return to usual activities for 12 weeks.
|
|---|---|---|
|
People With Memory Loss (PWML) Cognitive Function - Change (Cognitive Function Instrument - Modified)
|
1.5 score on a scale
Standard Deviation 5.1
|
1.8 score on a scale
Standard Deviation 6.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 12 weeksPopulation: Applies to CPs only. Data missing for 2 Waitlist and 6 Moving Together CPs.
Total number of falls reported for CG for the entire group (not per CG)
Outcome measures
| Measure |
Waitlist Control - PLWD
n=41 Participants
Usual activities for 12 weeks followed by Moving Together classes (1 hour, 2 days/week) for 12 weeks.
|
Moving Together - PLWD
n=48 Participants
Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by return to usual activities for 12 weeks.
|
|---|---|---|
|
Caregiver (CG) Falls
|
6 falls
|
11 falls
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 12 weeksPopulation: Applies only to PLWD. Data missing for 2 Waitlist and 6 Moving Together participants.
Total number of falls reported for PWML in the entire group (not per participant).
Outcome measures
| Measure |
Waitlist Control - PLWD
n=41 Participants
Usual activities for 12 weeks followed by Moving Together classes (1 hour, 2 days/week) for 12 weeks.
|
Moving Together - PLWD
n=48 Participants
Synchronous, online, mind-body group movement classes (1 hour, 2 days/week) for 12 weeks followed by return to usual activities for 12 weeks.
|
|---|---|---|
|
People With Memory Loss (PWML) Falls
|
26 falls
|
16 falls
|
Adverse Events
Immediate Start - Care Partners (CPs)
Immediate Start - Participants Living With Dementia (PLWD)
Delayed Start - Care Partners (CPs)
Delayed Start - Participants Living With Dementia (PLWD)
Serious adverse events
| Measure |
Immediate Start - Care Partners (CPs)
n=54 participants at risk
The Immediate Start group will participate in Moving Together classes (1 hour, 2 days/week) for 12 weeks and will then return to usual activities for 12 weeks. Adverse events are reported separately for care partners (CPs) and participants living with dementia (PLWD).
|
Immediate Start - Participants Living With Dementia (PLWD)
n=54 participants at risk
The Immediate Start group will participate in Moving Together classes (1 hour, 2 days/week) for 12 weeks and will then return to usual activities for 12 weeks. Adverse events are reported separately for care partners (CPs) and participants living with dementia (PLWD).
|
Delayed Start - Care Partners (CPs)
n=43 participants at risk
The Delayed Start group will engage in usual activities for 12 weeks and will then participate in Moving Together classes (1 hour, 2 days/week) for 12 weeks. Adverse events are reported separately for care partners (CPs) and participants living with dementia (PLWD).
|
Delayed Start - Participants Living With Dementia (PLWD)
n=43 participants at risk
The Delayed Start group will engage in usual activities for 12 weeks and will then participate in Moving Together classes (1 hour, 2 days/week) for 12 weeks. Adverse events are reported separately for care partners (CPs) and participants living with dementia (PLWD).
|
|---|---|---|---|---|
|
General disorders
Other
|
1.9%
1/54 • Number of events 1 • 24 weeks
Care partners are sent a month survey that asks about hospitalizations, emergency department visits, falls, and other unexpected major medical events or changes to health in the past month for themselves and PLWD. We did not group events by organ system; therefore, they are reported as general events.
|
13.0%
7/54 • Number of events 11 • 24 weeks
Care partners are sent a month survey that asks about hospitalizations, emergency department visits, falls, and other unexpected major medical events or changes to health in the past month for themselves and PLWD. We did not group events by organ system; therefore, they are reported as general events.
|
2.3%
1/43 • Number of events 1 • 24 weeks
Care partners are sent a month survey that asks about hospitalizations, emergency department visits, falls, and other unexpected major medical events or changes to health in the past month for themselves and PLWD. We did not group events by organ system; therefore, they are reported as general events.
|
7.0%
3/43 • Number of events 3 • 24 weeks
Care partners are sent a month survey that asks about hospitalizations, emergency department visits, falls, and other unexpected major medical events or changes to health in the past month for themselves and PLWD. We did not group events by organ system; therefore, they are reported as general events.
|
Other adverse events
| Measure |
Immediate Start - Care Partners (CPs)
n=54 participants at risk
The Immediate Start group will participate in Moving Together classes (1 hour, 2 days/week) for 12 weeks and will then return to usual activities for 12 weeks. Adverse events are reported separately for care partners (CPs) and participants living with dementia (PLWD).
|
Immediate Start - Participants Living With Dementia (PLWD)
n=54 participants at risk
The Immediate Start group will participate in Moving Together classes (1 hour, 2 days/week) for 12 weeks and will then return to usual activities for 12 weeks. Adverse events are reported separately for care partners (CPs) and participants living with dementia (PLWD).
|
Delayed Start - Care Partners (CPs)
n=43 participants at risk
The Delayed Start group will engage in usual activities for 12 weeks and will then participate in Moving Together classes (1 hour, 2 days/week) for 12 weeks. Adverse events are reported separately for care partners (CPs) and participants living with dementia (PLWD).
|
Delayed Start - Participants Living With Dementia (PLWD)
n=43 participants at risk
The Delayed Start group will engage in usual activities for 12 weeks and will then participate in Moving Together classes (1 hour, 2 days/week) for 12 weeks. Adverse events are reported separately for care partners (CPs) and participants living with dementia (PLWD).
|
|---|---|---|---|---|
|
General disorders
Any Adverse Event
|
5.6%
3/54 • Number of events 10 • 24 weeks
Care partners are sent a month survey that asks about hospitalizations, emergency department visits, falls, and other unexpected major medical events or changes to health in the past month for themselves and PLWD. We did not group events by organ system; therefore, they are reported as general events.
|
31.5%
17/54 • Number of events 32 • 24 weeks
Care partners are sent a month survey that asks about hospitalizations, emergency department visits, falls, and other unexpected major medical events or changes to health in the past month for themselves and PLWD. We did not group events by organ system; therefore, they are reported as general events.
|
18.6%
8/43 • Number of events 14 • 24 weeks
Care partners are sent a month survey that asks about hospitalizations, emergency department visits, falls, and other unexpected major medical events or changes to health in the past month for themselves and PLWD. We did not group events by organ system; therefore, they are reported as general events.
|
34.9%
15/43 • Number of events 34 • 24 weeks
Care partners are sent a month survey that asks about hospitalizations, emergency department visits, falls, and other unexpected major medical events or changes to health in the past month for themselves and PLWD. We did not group events by organ system; therefore, they are reported as general events.
|
Additional Information
Dr. Deborah Barnes
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place