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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

224 participants

Primary outcome timeframe

Baseline to 12-weeks

Results posted on

2025-04-22

Participant Flow

Study participants are enrolled as dyads of persons living with dementia (PLWD) and care partners (CPs).

Participant milestones

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

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

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-weeks

Population: 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

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-weeks

Population: 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

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 weeks

Population: 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

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-weeks

Population: 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

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-weeks

Population: 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

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-weeks

Population: 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

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-weeks

Population: 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

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-weeks

Population: 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

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-weeks

Population: 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

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-weeks

Population: 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

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-weeks

Population: 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

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-weeks

Population: 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

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-weeks

Population: 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

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-weeks

Population: 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

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-weeks

Population: 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

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-weeks

Population: 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

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-weeks

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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)

Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths

Immediate Start - Participants Living With Dementia (PLWD)

Serious events: 7 serious events
Other events: 17 other events
Deaths: 0 deaths

Delayed Start - Care Partners (CPs)

Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths

Delayed Start - Participants Living With Dementia (PLWD)

Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths

Serious adverse events

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

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

Phone: 415-502-2943

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place