Clinical trial NCT03333837: Improvisational Movement for People With Memory Loss and Their Caregivers
Official title: IMOVE: Improvisational Movement for People With Memory Loss and Their Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2017-11-07
Enrollment: 104
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Dementia is a progressive decline in cognition that impairs a person's ability to perform activities of daily living. Alzheimer's disease is the most common form of dementia, the most common neurodegenerative disease in older adults, and the 6th leading cause of death in the US. Neuropsychiatric symptoms (apathy, depression, anxiety) and altered gait and balance are prominent secondary symptoms of Alzheimer's disease that increase medical costs and decrease quality of life for both the person with dementia and their caregiver.

In a report from the Secretariat (Executive Board, 134th Session, December 20th, 2013), the World Health Organization identified a need to integrate evidence-based palliative care services into the continuum of care for serious chronic diseases, including Alzheimer's disease. However, two recent NIH workshops identified major gaps in the evidence supporting the wider use of non-pharmacologic activities to ameliorate secondary symptoms of chronic disease. Arts-based activities were identified as particularly understudied for symptom management, given growing evidence that various arts-based activities can improve quality of life, relieve symptoms, and reduce reliance on medications. It is important that these benefits can be achieved without adding medications. Dance is an arts-based activity that can improve quality of life, decrease symptoms of depression, and improve balance in healthy older adults, those with Parkinson disease, and Alzheimer's disease. Thus, dance is a non-pharmacological intervention that simultaneously addresses two sets of prominent secondary symptoms in Alzheimer's disease: 1) gait and balance and 2) neuropsychiatric symptoms. However, the mechanisms through which dance exerts these effects are unknown.

Pilot data from the investigators' laboratory suggest that participating in a group improvisational movement class twice weekly improved balance and connectivity in motor-related brain regions, as well as improving mood and connectivity in brain regions associated with social engagement. Improvisation is the ability to create new gestures and movements spontaneously. Improvisation can be a part of many different art forms. However, improvisational movement can also be practiced as a specific dance form. The objective in improvisational movement is that choreographed movement is replaced by a cue or prompt that allows the possibility for multiple responses. This unique form of dance is especially well-suited for people with dementia because it: 1) does not rely heavily on memory of repeated movements; 2) can be seamlessly adapted to include sitting, standing, or moving around the room; 3) is cognitively challenging; and 4) fosters a social, playful atmosphere. Participants seemed to benefit from both the social nature of the class and the movement. Therefore, the overall aim of this proposal is to experimentally 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.

To accomplish this goal, the investigators will use a 2x2 factorial design and randomize 120 community-dwelling older adults adjudicated as having early-stage dementia of the presumed Alzheimer's type to one of four 3-month interventions: 1) Dance Group, 2) Non-group Dance, 3) Social Group, or 4) No Contact Control.

It is not hypothesized that dance affects the underlying disease course, and therefore no improvement is expected in cognition.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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

Primary outcomes:
measure: Quality of Life in Alzheimer's Disease (QOL-AD)--Participants With Dementia (PWD)
timeFrame: Baseline
measure: QOL-AD--PWD
timeFrame: Week 12
Secondary outcomes:
measure: Community Structure--PWD
timeFrame: Baseline
measure: Community Structure--PWD
timeFrame: Week 12
measure: Global Efficiency (eGlob)--PWD
timeFrame: Baseline
measure: Global Efficiency (eGlob)--PWD
timeFrame: Week 12
measure: Local Efficiency (eLoc)--PWD
timeFrame: Baseline
measure: Local Efficiency (eLoc)--PWD
timeFrame: Week 12
measure: Path Length--PWD
timeFrame: Baseline
measure: Path Length--PWD
timeFrame: Week 12
measure: Fullerton Advanced Balance Scale (Overall Balance) PWD
timeFrame: Baseline
measure: Fullerton Advanced Balance Scale (Overall Balance) PWD
timeFrame: Week 12
measure: Falls Efficacy Scale - International (FES) PWD
timeFrame: Baseline
measure: Falls Efficacy Scale - International (FES) PWD
timeFrame: Week 12
measure: Neuropsychiatric Inventory Questionnaire (NPI-Q)
timeFrame: Baseline
measure: NPI-Q
timeFrame: Week 12
measure: Geriatric Depression Scale
timeFrame: Baseline
measure: Geriatric Depression Scale
timeFrame: Week 12
measure: Geriatric Anxiety Scale
timeFrame: Baseline
measure: Geriatric Anxiety Scale
timeFrame: Week 12
measure: Apathy Evaluation Scale--PWD
timeFrame: Baseline
measure: Apathy Evaluation Scale--PWD
timeFrame: Week 12
measure: Expanded Short Physical Performance Battery (eSPPB)
timeFrame: Baseline
measure: Expanded Short Physical Performance Battery (eSPPB)
timeFrame: Week 12
measure: Postural Sway--PWD
timeFrame: Baseline
measure: Postural Sway--PWD
timeFrame: Week 12
measure: Gait Speed--PWD
timeFrame: Baseline
measure: Gait Speed--PWD
timeFrame: Week 12
measure: Gait Variability--PWD
timeFrame: Baseline
measure: Gait Variability--PWD
timeFrame: Week 12
Other outcomes:
measure: Body Mass Index (BMI)
timeFrame: Baseline, Week 12
measure: Blood Pressure
timeFrame: Baseline, Week12
measure: Neuroticism-Extraversion-Openness Five-Factor Inventory (NEO-FFI)
timeFrame: Baseline
measure: White Matter Lesion Burden
timeFrame: Baseline, Week 12
measure: Blood-based Stress Biomarkers (Covariate or Alternative Hypothesis)
timeFrame: Baseline, Week 12
measure: Caregiver Quality of Life With the 36-item Short-Form Health (SF-36)--Covariate or Alternative Hypothesis
timeFrame: Baseline, Week 12
measure: Caregiver Burden With Zarit Caregiver Burden Scale--Covariate or Alternative Hypothesis
timeFrame: Baseline, Week 12
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Assistant Professor Gerontology and Geriatric Medicine
name: Christina Hugenschmidt, PhD
role: PRINCIPAL_INVESTIGATOR
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