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

NCT04621448 | Completed Results DMC

• 1 other identifier: R44AG059520
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease; Dementia

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline to 12 weeks

Secondary Outcomes (14)

• Well-being - Change (Neuro-QOL v1.0 Positive Affect and Well-Being Short Form)

  Baseline to 12-weeks

• Social Isolation - Change (Patient-Reported Outcomes Measurement Information System v2.0 Social Isolation Scale)

  Baseline to 12-weeks

• Mobility - Change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility)

  Baseline to 12-weeks

• Cognitive Function - Change (Telephone Montreal Cognitive Assessment, t-MoCA)

  Baseline to 12-weeks

• Caregiver Healthy Days - Change (Healthy Days Core Module)

  Baseline to 12-weeks

Other Outcomes (2)

• Caregiver (CG) Falls

  Baseline to 12 weeks

• People With Memory Loss (PWML) Falls

  Baseline to 12 weeks

Study Arms (2)

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.

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.

Behavioral: Moving Together

Interventions

Moving Together BEHAVIORAL

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.

Also known as: Together Senior Health

Delayed Start; Immediate Start

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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);
• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (5)

• 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.

  PMID: 25671576 BACKGROUND

• 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.

  PMID: 30744387 BACKGROUND

• 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.

  PMID: 25022459 BACKGROUND

• 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.

  PMID: 37745819 BACKGROUND

• 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.

  PMID: 38698931 RESULT

Related Links

• Published results

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Deborah Barnes
• Organization: University of California, San Francisco

deborah.barnes@ucsf.edu

415-502-2943

Study Officials

• Deborah Barnes, PhD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Dyads will be enrolled and randomized in blocks of 16 (n=8 immediate start, n=8 waitlist). The randomization sequence will be generated in advance by Dr. Barnes' team using a random number generator and will be maintained in a secure location. Individuals who collect or analyze outcome data will be unaware of the randomization sequence and blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Delayed-start control group

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 9, 2020
• Study Start: November 18, 2020
• Primary Completion: May 3, 2023
• Study Completion: May 12, 2023
• Last Updated: April 22, 2025
• Results First Posted: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)