Alzheimer DiseaseNCT04621448

Moving Together: An Online Group Movement Program for People Living With Memory Loss and Caregivers

A study testing Moving Together in people with Alzheimer Disease and Dementia, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To determine whether Moving Together improves quality of life in people with memory loss (PWML) and caregivers (CG) by performing a randomized, controlled trial (RCT) with a waitlist control group in 224 dyads. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Alzheimer Disease, Dementia
What is being tested?: Moving Together
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 224 participants
Where: 1 siteUnited States
Study dates: 18 Nov 2020to 12 May 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

People with memory loss (PWML):
U.S. resident;
English language fluency;
diagnosis of Alzheimer's disease or other dementia; mild severity, assessed using the Quick Dementia Rating System.
Caregivers (CG):
U.S. resident;

Show all 10Show fewer

English language fluency;
Primary caregiver for PWML;
own one or more devices that can be used to participate in two-way livestreaming video classes (e.g., smart phone/tablet + TV, laptop or desktop with webcam, smart TV);
willing and able to participate in two-way livestreaming group movement classes with person with PWML.

Who cannot join

Age < 18 years;
primarily use wheelchair inside home;
limited life expectancy (e.g., enrolled in hospice, meta-static cancer);
physical limitations that could affect ability to participate (e.g., difficulty sitting for 1 hour, chronic pain, vertigo);
severe visual impairment (e.g., unable to observe instructor's movements on screen);
severe hearing impairment (e.g., unable to hear instructor's requests);

Show all 9Show fewer

behavioral or psychiatric issues that could be disruptive in group setting (e.g., history of physical or verbal abuse, schizophrenia, bipolar disorder, substance abuse);
unable to provide consent/assent;
planning to travel for >1 week during initial 12-week study period.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of California, San Francisco
San Francisco, California, 94143

Other trials in United States

About this study

Official title: Extending Independence and Quality of Life for People With Alzheimer's Disease or Dementia Through Telehealth Program Delivery

Read the detailed description

The investigators will perform an RCT with a 12-week delayed start control group in 224 dyads of PWMLs and CGs. The primary outcome in PWML will be self-rated quality of life (Quality of Life in Alzheimer's Disease, QOL-AD). Secondary outcomes will include: a) self-reported emotional well-being; b) self-reported social isolation; c) self-reported mobility; and d) directly assess cognitive performance. In CGs, the primary outcome will be self-rated quality of life (SF-12). Secondary outcomes in CGs will include: a) healthy days; b) self-efficacy; c) burden; d) social isolation; e) ability to self-regulate; f) positive affect; and g) sleep quality. In addition, the investigators will ask CGs to report sleep quality, mobility, and cognitive function for PWML. Additional exploratory outcomes will include health services utilization (hospitalizations, emergency department visits) and falls.

In addition to the RCT, the investigators propose to compare health utilization outcomes in study participants to a matched 'no contact' comparison sample of patients with dementia diagnoses who receive care in the University of California San Francisco (UCSF) Health system.

Conditions: Alzheimer Disease, Dementia
Being tested: Moving Together
Medical subject headings: Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Moving TogetherBehavioural
Also called Together Senior Health
Two-way livestreaming virtual group classes will be offered for 1 hour, 2 days/week for 12 weeks to all participants. Classes will be led by a trained instructor who will demonstrate all movements and will provide brief explanations for the goals of movements. Consistent with the in-person program, classes will focus on the 7 guiding principles of Moving Together:
1. repetition with variation (to promote procedural learning);
2. progressive, functional movements (to improve daily function);
3. slow pace and step-by-step instruction (to minimize cognitive demands);
4. participant-centered goal orientation (to enhance personal meaningfulness of movements);
5. body awareness, mindfulness and breathing (to encourage present-centeredness);
6. social interaction (to promote meaningful connection); and
7. positive emotions (to promote feelings of well-being.

Study groups in NCT04621448
Study group	Role	What they receive
Immediate Start	Experimental	The Immediate Start group will participate in the 12-week Moving Together program after completing the baseline assessment. Moving Together is a gentle, live-streaming, group movement program designed specifically for people with memory loss (PWML) and caregivers (CG) to do together. It is based on the in-person Preventing Loss of Independence through Exercise (PLIÉ) and Paired PLIÉ programs. The program combines physical movements to help maintain daily function with mindful body awareness exercises and social interactions to provide a comprehensive, multi-domain program. Receives: Behavioral: Moving Together
Delayed Start	Experimental	A Delayed Start group will be encouraged to continue with their usual daily activities during the first 12 weeks of the study and will begin the Moving Together program after completing the mid-point assessment. Receives: Behavioral: Moving Together

What is being measured

The primary outcome is the main question the study is designed to answer.

Quality of Life - Change (Quality of Life in Alzheimer's Disease Scale, QOL-AD)
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.
Measured: Baseline to 12-weeks
Caregiver Physical Health - Change (Short Form Health Survey [SF-12] Physical Composite Score [PCS])
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.
Measured: Baseline to 12-weeks
Caregiver Mental Health - Change (Short Form - 12 [SF-12] Mental Composite Score [MCS])
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.
Measured: Baseline to 12 weeks

Secondary outcomes (14)

Well-being - Change (Neuro-QOL v1.0 Positive Affect and Well-Being Short Form)
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.
Measured: Baseline to 12-weeks
Social Isolation - Change (Patient-Reported Outcomes Measurement Information System v2.0 Social Isolation Scale)
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.
Measured: Baseline to 12-weeks
Mobility - Change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility)
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.
Measured: Baseline to 12-weeks
Cognitive Function - Change (Telephone Montreal Cognitive Assessment, t-MoCA)
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.
Measured: Baseline to 12-weeks
Caregiver Healthy Days - Change (Healthy Days Core Module)
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.
Measured: Baseline to 12-weeks
Caregiver Self-efficacy - Change (Gain in Alzheimer Care INstrument (GAIN))
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
Measured: Baseline to 12-weeks
Caregiver Burden - Change (Zarit Burden Interview, 6-item Version)
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.
Measured: Baseline to 12-weeks
Caregiver Social Isolation - Change (PROMIS v2.0 Social Isolation Scale)
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.
Measured: Baseline to 12-weeks
Caregiver Self-regulation - Change (Abbreviated Multidimensional Assessment of Interoceptive Awareness-2 (MAIA) Self-regulation Subscale)
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.
Measured: Change from baseline to 12-weeks
Caregiver Positive Affect (Positive States of Mind)
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.
Measured: Baseline to 12-weeks
Caregiver Sleep - Change (Symptom Checklist, 3 Items)
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.
Measured: Baseline to 12-weeks
People With Memory Loss (PWML) Sleep - Change (Symptom Checklist, 3 Items)
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.
Measured: Baseline to 12-weeks
People With Memory Loss (PWML) Mobility - Change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility)
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.
Measured: Baseline to 12-weeks
People With Memory Loss (PWML) Cognitive Function - Change (Cognitive Function Instrument - Modified)
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.
Measured: Baseline to 12-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Nov 202012 May 2023

First posted9 Nov 2020
Study start18 Nov 2020
Primary completion3 May 2023
Study completion12 May 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
More trials run by University of California, San FranciscoThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: Delayed-start control group
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 224 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04621448
Sponsor's protocol ID: R44AG059520
Other IDs: R44AG059520
Status last verified: Apr 2025
First submitted: 3 Nov 2020
Last updated: 22 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Sharing permissions will be configured to ensure files containing PHI can only be accessed by authorized individuals. Two-step verification will be used as an additional safeguard against unauthorized access. Permissions will be updated when personnel roles change and they no longer need access to PHI or when they leave the research team.

Publications

Barnes DE, Mehling W, Wu E, Beristianos M, Yaffe K, Skultety K, Chesney MA. Preventing loss of independence through exercise (PLIE): a pilot clinical trial in older adults with dementia. PLoS One. 2015 Feb 11;10(2):e0113367. doi: 10.1371/journal.pone.0113367. eCollection 2015.
PubMed 25671576
Casey JJ, Harrison KL, Ventura MI, Mehling W, Barnes DE. An integrative group movement program for people with dementia and care partners together (Paired PLIE): initial process evaluation. Aging Ment Health. 2020 Jun;24(6):971-977. doi: 10.1080/13607863.2018.1553142. Epub 2019 Feb 12.
PubMed 30744387
Wu E, Barnes DE, Ackerman SL, Lee J, Chesney M, Mehling WE. Preventing Loss of Independence through Exercise (PLIE): qualitative analysis of a clinical trial in older adults with dementia. Aging Ment Health. 2015;19(4):353-62. doi: 10.1080/13607863.2014.935290. Epub 2014 Jul 14.
PubMed 25022459
Nicosia FM, Lee JA, Chesney MA, Benjamin C, Lee AN, Mehling W, Sudore RL, Barnes DE. Adaptation of an In-Person Mind-Body Movement Program for People with Cognitive Impairment or Dementia and Care Partners for Online Delivery: Feasibility, Satisfaction and Participant-Reported Outcomes. Glob Adv Integr Med Health. 2023 Sep 21;12:27536130231202989. doi: 10.1177/27536130231202989. eCollection 2023 Jan-Dec.
PubMed 37745819
Barnes DE, Jiang F, Benjamin C, Lee JA, Sudore RL, Mehling WE, Chesney MA, Chao LL, Nicosia FM. Livestream, group movement program for people living with cognitive impairment and care partners: A randomized clinical trial. Alzheimers Dement (N Y). 2024 May 2;10(2):e12467. doi: 10.1002/trc2.12467. eCollection 2024 Apr-Jun.
PubMed 38698931

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease

All Alzheimer Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Extending Independence and Quality of Life for People With Alzheimer's Disease or Dementia Through Telehealth Program Delivery
ClinicalTrials.gov ID: NCT04621448
Acronym / sponsor ID: R44AG059520
Conditions: Alzheimer Disease, Dementia
Study type: Interventional
Recruitment status: Completed
Enrolment: 224 participants (actual)
Lead sponsor: University of California, San FranciscoUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 18 Nov 2020 (actual)
Primary completion: 3 May 2023 (actual)
Study completion: 12 May 2023 (actual)
First posted: 9 Nov 2020 (actual)
Results: Posted 22 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Delayed-start control group

Arm	Type	Receives
Immediate Start	Experimental	Behavioral: Moving TogetherThe Immediate Start group will participate in the 12-week Moving Together program after completing the baseline assessment. Moving Together is a gentle, live-streaming, group movement program designed specifically for people with memory loss (PWML) and caregivers (CG) to do together. It is based on the in-person Preventing Loss of Independence through Exercise (PLIÉ) and Paired PLIÉ programs. The program combines physical movements to help maintain daily function with mindful body awareness exercises and social interactions to provide a comprehensive, multi-domain program.
Delayed Start	Experimental	Behavioral: Moving TogetherA Delayed Start group will be encouraged to continue with their usual daily activities during the first 12 weeks of the study and will begin the Moving Together program after completing the mid-point assessment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

People with memory loss (PWML):
Caregivers (CG):

Key exclusion criteria (9 listed)

Age < 18 years;
primarily use wheelchair inside home;
limited life expectancy (e.g., enrolled in hospice, meta-static cancer);
physical limitations that could affect ability to participate (e.g., difficulty sitting for 1 hour, chronic pain, vertigo);
severe visual impairment (e.g., unable to observe instructor's movements on screen);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Moving TogetherAlso: Together Senior HealthTwo-way livestreaming virtual group classes will be offered for 1 hour, 2 days/week for 12 weeks to all participants. Classes will be led by a trained instructor who will demonstrate all movements and will provide brief explanations for the goals of movements. Consistent with the in-person program, classes will focus on the 7 guiding principles of Moving Together: 1. repetition with variation (to promote procedural learning); 2. progressive, functional movements (to improve daily function); 3. slow pace and step-by-step instruction (to minimize cognitive demands); 4. participant-centered goal orientation (to enhance personal meaningfulness of movements); 5. body awareness, mindfulness and breathing (to encourage present-centeredness); 6. social interaction (to promote meaningful connection); and 7. positive emotions (to promote feelings of well-being.	Behavioural	Delayed Start, Immediate Start

Primary outcome

Quality of Life - Change (Quality of Life in Alzheimer's Disease Scale, QOL-AD)
Time frame: Baseline to 12-weeks
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.
Caregiver Physical Health - Change (Short Form Health Survey [SF-12] Physical Composite Score [PCS])
Time frame: Baseline to 12-weeks
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.
Caregiver Mental Health - Change (Short Form - 12 [SF-12] Mental Composite Score [MCS])
Time frame: Baseline to 12 weeks
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.

14 secondary outcomes

Well-being - Change (Neuro-QOL v1.0 Positive Affect and Well-Being Short Form)
Time frame: Baseline to 12-weeks
Social Isolation - Change (Patient-Reported Outcomes Measurement Information System v2.0 Social Isolation Scale)
Time frame: Baseline to 12-weeks
Mobility - Change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility)
Time frame: Baseline to 12-weeks
Cognitive Function - Change (Telephone Montreal Cognitive Assessment, t-MoCA)
Time frame: Baseline to 12-weeks
Caregiver Healthy Days - Change (Healthy Days Core Module)
Time frame: Baseline to 12-weeks
Caregiver Self-efficacy - Change (Gain in Alzheimer Care INstrument (GAIN))
Time frame: Baseline to 12-weeks
Caregiver Burden - Change (Zarit Burden Interview, 6-item Version)
Time frame: Baseline to 12-weeks
Caregiver Social Isolation - Change (PROMIS v2.0 Social Isolation Scale)
Time frame: Baseline to 12-weeks
Caregiver Self-regulation - Change (Abbreviated Multidimensional Assessment of Interoceptive Awareness-2 (MAIA) Self-regulation Subscale)
Time frame: Change from baseline to 12-weeks
Caregiver Positive Affect (Positive States of Mind)
Time frame: Baseline to 12-weeks
Caregiver Sleep - Change (Symptom Checklist, 3 Items)
Time frame: Baseline to 12-weeks
People With Memory Loss (PWML) Sleep - Change (Symptom Checklist, 3 Items)
Time frame: Baseline to 12-weeks
People With Memory Loss (PWML) Mobility - Change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility)
Time frame: Baseline to 12-weeks
People With Memory Loss (PWML) Cognitive Function - Change (Cognitive Function Instrument - Modified)
Time frame: Baseline to 12-weeks

Results and safety

Results posted to the registry on 22 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Waitlist Control - PLWD	43	37
Moving Together - PLWD	54	45
Waitlist Control - CP	43	37
Moving Together - CP	54	45

Primary outcome: Quality of Life - Change (Quality of Life in Alzheimer's Disease Scale, QOL-AD)

Time frame: Baseline to 12-weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Waitlist Control - PLWD n = 43	Moving Together - PLWD n = 53
Value	-1.7 (0.6)	0.7 (4.2)

Waitlist Control - PLWD vs Moving Together - PLWD: Mean Difference (Final Values): 2.2 (95% CI 0.01 to 4.39), p = 0.048, Mixed Models Analysis

Population analysed: Only measured in PLWD. Baseline data missing for 1 participant in the Moving Together group.

Primary outcome: Caregiver Physical Health - Change (Short Form Health Survey [SF-12] Physical Composite Score [PCS])

Time frame: Baseline to 12-weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Waitlist Control - CP n = 54	Moving Together - CP n = 43
Value	0.2 (8.0)	-0.6 (7.7)

Waitlist Control - CP vs Moving Together - CP: Mean Difference (Final Values): -0.9 (95% CI -4.12 to 2.40), p = 0.603, Mixed Models Analysis

Population analysed: Measured only in CPs.

Primary outcome: Caregiver Mental Health - Change (Short Form - 12 [SF-12] Mental Composite Score [MCS])

Time frame: Baseline to 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Waitlist Control - CP n = 43	Moving Together - CP n = 54
Value	-0.7 (7.9)	0.0 (8.1)

Waitlist Control - CP vs Moving Together - CP: Mean Difference (Final Values): 0.6 (95% CI -2.75 to 3.92), p = 0.734, Mixed Models Analysis

Population analysed: Only measured in CPs.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Immediate Start - Care Partners (CPs)	1 of 54 (1.9%)	3 of 54 (5.6%)	0 of 54
Immediate Start - Participants Living With Dementia (PLWD)	7 of 54 (13%)	17 of 54 (31.5%)	0 of 54
Delayed Start - Care Partners (CPs)	1 of 43 (2.3%)	8 of 43 (18.6%)	0 of 43
Delayed Start - Participants Living With Dementia (PLWD)	3 of 43 (7%)	15 of 43 (34.9%)	0 of 43

Limitations and caveats (from the sponsor): Dyads were enrolled in cohorts with a goal of 16 dyads per cohort. Our original target sample size of 224 dyads (112/group) was reduced to 112 dyads (56/group) following a futility analysis requested by our Safety Officer (SO). We did not penalize the alpha for this unplanned interim analysis. Due to time and funding constraints, the 7th (final) cohort only included 10 dyads, all of whom were assigned to the Immediate Start (Moving Together) group.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25671576Barnes DE, Mehling W, Wu E, Beristianos M, Yaffe K, Skultety K, Chesney MA. Preventing loss of independence through exercise (PLIE): a pilot clinical trial in older adults with dementia. PLoS One. 2015 Feb 11;10(2):e0113367. doi: 10.1371/journal.pone.0113367. eCollection 2015.
Background: PubMed 30744387Casey JJ, Harrison KL, Ventura MI, Mehling W, Barnes DE. An integrative group movement program for people with dementia and care partners together (Paired PLIE): initial process evaluation. Aging Ment Health. 2020 Jun;24(6):971-977. doi: 10.1080/13607863.2018.1553142. Epub 2019 Feb 12.
Background: PubMed 25022459Wu E, Barnes DE, Ackerman SL, Lee J, Chesney M, Mehling WE. Preventing Loss of Independence through Exercise (PLIE): qualitative analysis of a clinical trial in older adults with dementia. Aging Ment Health. 2015;19(4):353-62. doi: 10.1080/13607863.2014.935290. Epub 2014 Jul 14.
Background: PubMed 37745819Nicosia FM, Lee JA, Chesney MA, Benjamin C, Lee AN, Mehling W, Sudore RL, Barnes DE. Adaptation of an In-Person Mind-Body Movement Program for People with Cognitive Impairment or Dementia and Care Partners for Online Delivery: Feasibility, Satisfaction and Participant-Reported Outcomes. Glob Adv Integr Med Health. 2023 Sep 21;12:27536130231202989. doi: 10.1177/27536130231202989. eCollection 2023 Jan-Dec.
Results publication: PubMed 38698931Barnes DE, Jiang F, Benjamin C, Lee JA, Sudore RL, Mehling WE, Chesney MA, Chao LL, Nicosia FM. Livestream, group movement program for people living with cognitive impairment and care partners: A randomized clinical trial. Alzheimers Dement (N Y). 2024 May 2;10(2):e12467. doi: 10.1002/trc2.12467. eCollection 2024 Apr-Jun.
Published resultsLink provided by the sponsor.
Individual participant dataSharing planned: No. Sharing permissions will be configured to ensure files containing PHI can only be accessed by authorized individuals. Two-step verification will be used as an additional safeguard against unauthorized access. Permissions will be updated when personnel roles change and they no longer need access to PHI or when they leave the research team.

Related trials for Alzheimer Disease

RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Deborah Barnes, PhD, MPH principal investigator

University of California, San Francisco

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Moving Together in people with Alzheimer Disease and Dementia, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life - Change (Quality of Life in Alzheimer's Disease Scale, QOL-AD) (time frame: Baseline to 12-weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04621448, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.