Improvisational Movement for People With Memory Loss and Their Caregivers

NCT03333837 | Completed Results DMC

• 2 other identifiers: IRB00042460R01AT009444
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Dementia is a progressive decline in cognition that impairs a person's ability to perform activities of daily living. Changes in mood, gait, and balance are prominent secondary symptoms of Alzheimer's dementia that can dramatically decrease quality of life for the person with dementia and increase caregiver burden. The overall aim of this study is to determine the independent and combined effects of dance movement and social engagement on quality of life in people with early-stage dementia, and test the neural mechanisms of these effects.

Conditions

Alzheimer's Disease (Incl Subtypes); Dementia; Mild Cognitive Impairment

Keywords

Improvisation; Memory loss; Caregivers; Quality of Life; Dance; Social Group; MRI; mild cognitive impairment; MCI; Social engagement

Outcome Measures

Primary Outcomes (2)

• Quality of Life in Alzheimer's Disease (QOL-AD)--Participants With Dementia (PWD)

  Self-reported quality of life in the person with dementia is the primary outcome and will be measured using the QOL-AD . The QOL-AD is validated for use in people with Mini Mental State Exam scores as low as 10.The QOL\_AD contains 13 items.Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4.The total score is the sum of all 13 item (range 13- 52) higher scores represent better outcomes.

  Baseline

• QOL-AD--PWD

  Self-reported quality of life in the person with dementia is the primary outcome and will be measured using the QOL-AD . The QOL-AD is validated for use in people with Mini Mental State Exam scores as low as 10.The QOL\_AD contains 13 items.Points are assigned to each item as follows: poor = 1, fair = 2, good = 3, excellent = 4.The total score is the sum of all 13 item (range 13- 52) higher scores represent better outcomes.

  Week 12

Secondary Outcomes (28)

• Community Structure--PWD

  Baseline

• Community Structure--PWD

  Week 12

• Global Efficiency (eGlob)--PWD

  Baseline

• Global Efficiency (eGlob)--PWD

  Week 12

• Local Efficiency (eLoc)--PWD

  Baseline

Other Outcomes (7)

• Body Mass Index (BMI)

  Baseline, Week 12

• Blood Pressure

  Baseline, Week12

• Neuroticism-Extraversion-Openness Five-Factor Inventory (NEO-FFI)

  Baseline

Study Arms (4)

Dance Group

ACTIVE COMPARATOR

The Dance Group will participate in 1-hour group improvisational dance lessons 2x/week for 12 weeks. Improvisational dance classes are grounded in 4 principles that shape the tone of the class and result in a sense of social belonging: non-judgment, non-competitiveness, curiosity, and playfulness. The following training strategies are used to maintain: active imagination, variability, and pacing.

Behavioral: Dance Group

Non-group Dance

ACTIVE COMPARATOR

The Non-group dance intervention is designed to capture the same dance movement and auditory stimuli as the group class without social interaction. Recordings of the dance instructor teaching a dance class will be played. This will ensure participants hear comparable music and receive comparable verbal auditory cues to prompt dance movements that students in the group class will hear, without interacting with other people. Improvisational dance is particularly suited for this means of delivery because the primary method of instruction is verbal auditory cueing. Participants will be asked to follow the same schedule as participants in the Dance Group arm and complete 2 one-hour dance sessions each week.

Behavioral: Non-Group Dance

Social Group

ACTIVE COMPARATOR

The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.

Behavioral: Social Group

No Contact

SHAM COMPARATOR

A No Contact condition captures the condition of no added social contact and no added dance movement. Participants randomized to the No Contact condition will be asked to continue their current disease management and lifestyle for 12 weeks

Behavioral: No Contact

Interventions

Dance Group BEHAVIORAL

Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.

Dance Group

Non-Group Dance BEHAVIORAL

The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.

Non-group Dance

Social Group BEHAVIORAL

The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.

Social Group

No Contact BEHAVIORAL

The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.

No Contact

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60-85 years
• Adjudicated as having mild cognitive impairment or early-stage dementia of Alzheimer's, vascular, or mixed Alzheimer's/vascular type
• MRI compatible
• English speaking
• Have study partner who is around the person with dementia approximately 10 hours/week and is willing to be an active study partner.
• Able to attend bi-weekly intervention classes or come to study visits for no-contact control.
• Not enrolled in another interventional study for at least 3 months prior to beginning this study.

You may not qualify if:

• Untreated depression
• Other causes of dementia (for example, frontotemporal, early onset, Lewy body or Parkinsonian dementia)
• Current cancer treatment or other major medical problems that might independently affect cognition or movement
• Other neurological disorders (e.g., Parkinson disease, multiple sclerosis)
• Taking medication that could negatively influence safety during intervention
• Planned extensive travel during the study period
• Any reason for which the study doctor or personal physician feels the intervention is contraindicated for the participant

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27104, United States

Location

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MeSH Terms

Conditions

Alzheimer Disease; Dementia; Cognitive Dysfunction; Memory Disorders

Interventions

Social Group

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Results Point of Contact

• Title: Christina Hugenschmidt, PhD
• Organization: Wake Forest University School of Medicine

chugensc@wakehealth.edu

336-713-8116

Study Officials

• Christina Hugenschmidt, PhD

  Assistant Professor Gerontology and Geriatric Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All study assessments will be conducted by experienced staff certified annually on the proper conduct of study assessments and blinded to group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial. Investigators will use a 2x2 factorial design to test the separate and combined effects of social engagement and dance movement on QoL in 120 community-dwelling older adults adjudicated as having mild cognitive impairment (MCI) or early-stage dementia of the presumed AD or mixed AD/vascular type. Participants will be randomized to one of four 12-week interventions: 1) Dance Group 2) Non-group Dance, 3) Social Group, or 4) No Contact Control.

Study Record Dates

• First Submitted: November 1, 2017
• First Posted: November 7, 2017
• Study Start: February 6, 2018
• Primary Completion: May 26, 2021
• Study Completion: May 26, 2021
• Last Updated: July 27, 2022
• Results First Posted: July 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)