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Improvisational Movement for People With Memory Loss and Their Caregivers (IMOVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03333837
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : November 26, 2019
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease (Incl Subtypes) Dementia Mild Cognitive Impairment Behavioral: Dance Group Behavioral: Non-Group Dance Behavioral: Social Group Behavioral: No Contact Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description: All study assessments will be conducted by experienced staff certified annually on the proper conduct of study assessments and blinded to group assignment.
Primary Purpose: Supportive Care
Official Title: IMOVE: Improvisational Movement for People With Memory Loss and Their Caregivers
Actual Study Start Date : February 6, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dance Group
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
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.

Active Comparator: Non-group Dance
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
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.

Active Comparator: Social Group
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
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.

Sham Comparator: No Contact
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
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.




Primary Outcome Measures :
  1. Change in quality of life in participants with dementia using the QOL-AD [ Time Frame: 12 and 24 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in overall mobility using the Expanded Short Physical Performance Battery (eSPPB) [ Time Frame: 12 and 24 weeks ]
    Expanded Short Physical Performance Battery (eSPPB). The SPPB is a brief test of global mobility function with excellent test-retest and inter-examiner reliability; is sensitive to change; is safe, and is a robust predictor of future physical disability and death. To avoid ceiling effects, investigators will use an expanded version (eSPPB) that increases the difficulty of the standing balance task by asking participants to hold postures for 30 instead of 10 seconds, adds a one-leg stand, and adds a narrow walk. The resulting score is normally distributed, continuous, and shows greater sensitivity to change. Dementia patients have lower scores on the SPPB so a favorable outcome for this outcome measure would be a significantly higher score post treatment. The test is 3 sections each on scales of 0-4 with a total score scale of 0-12 with 12 being the best possible outcome.

  2. Change in Fullerton Advanced Balance Scale (overall balance) [ Time Frame: 12 and 24 weeks ]
    Fullerton Advanced Balance Scale (FAB) measures balance using 10 different performance-based tests (scored 0 worst - 4 best), including; standing with feet together and eyes closed, standing on a foam pad with eyes closed, walking while turning the head from side to side rhythmically, functional standing reach, turning around to the left and right, stepping up and over a 6-inch box, standing on one leg, and a test for postural reaction. The scale goes from 0-40 with 40 being the best outcome and a cutoff of <=25 for risk of falls.

  3. Change in graph theory-derived measures of network structure calculated on fMRI images. [ Time Frame: 12 weeks ]
    Participants with dementia will complete 1-hour MRI scans in visits 2 and 3 that will include images needed to compare functional brain networks before and after intervention (T1-weighted anatomical image, fMRI images)

  4. Change in mood and neuropsychiatric symptoms using the Neuropsychiatric Inventory Questionnaire [ Time Frame: 12 and 24 weeks ]
    The NPI is a reliable and valid structured interview designed to assess neuropsychiatric symptoms in person with dementia through a structured interview with the caregiver. The NPI includes questions about 12 domains of symptoms: delusions, hallucinations, agitation/aggression, depression, anxiety, elation/ euphoria, apathy, disinhibition, irritability, aberrant motor activity, sleep, and eating. The NPI is split into two sections for scoring, severity on a scale of 0-4, with 4 being the worst outcome. The other section is the caregiver distress, which goes from 0-5, with 5 being the worst outcome. Scores of 3 and 5 would represent the worst outcomes for the NPI.

  5. Change in depressive and anxiety symptoms of the person with dementia with the Geriatric Depression and Anxiety Scales [ Time Frame: 12 and 24 weeks ]
    The person with dementia will be asked to complete a screening tool for assessing depression. This test has 15 yes/no questions with a yes receiving 1 point for a depressive answer. A total score is calculated and will be on a scale from 0-15 with 0-4 indicating no depression, 5-10 suggestive of a mild depression, and 11+ suggestive of severe depression.

  6. Change in apathy of the person with dementia using the Apathy Evaluation Scale [ Time Frame: 12 and 24 weeks ]
    The Apathy Evaluation Scale (AES) addresses characteristics of goal directed behavior that reflect apathy including behavioral, cognitive, and emotional indicators. A short form will be used that has been modified for use with people with dementia. This shortened version has 10 questions scored 1-4 with 4 being the positive outcome answer. The total score is calculated and on a scale of 10-40 with lower scores reflecting less apathy and thus a better outcome.

  7. Change in fear of falling using the Falls Efficacy Scale - International (FES) [ Time Frame: 12 and 24 weeks ]
    A 16-item scale to assess fear of falling where higher scores reflect a higher fear and risk of falling.


Other Outcome Measures:
  1. Change in caregiver quality of life with the SF-36 (covariate or alternative hypothesis) [ Time Frame: 12 and 24 weeks ]
    The 36-item Short-Form Health Survey consists of 36 questions assessing physical functioning, role functioning difficulties caused by physical problems, bodily pain, general health, vitality, social functioning, role functioning difficulties caused by emotional problems, and mental health. High scores are representative of a great health status and better outcomes, while low scores are representative of a poor health status.

  2. Change in caregiver burden with Zarit Caregiver Burden Scale (covariate or alternative hypothesis) [ Time Frame: 12 and 24 weeks ]
    The Zarit Caregiver Burden Scale is administered in interview form to the caregiver. It consists of 22 questions scored 0-4 with 0=Never, 1=Rarely, 2=Sometimes, 3=Quite Frequently, 4=Nearly Always. The total score range is 0-88 with 88 being the worst possible outcome. 0-20 represents little or no burden on the caregiver, 21-40 represents mild to moderate burden, 41-60 represents moderate to severe burden, and 61-88 represents severe burden.

  3. Change in blood-based stress biomarkers (covariate or alternative hypothesis) [ Time Frame: 12 weeks ]
    Social engagement may change biomarkers of stress relevant for interpreting outcomes. These stress biomarkers include cortisol and allostatic load, a composite measure of blood-based biomarkers associated with chronically elevated stress.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333837


Contacts
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Contact: Ashley Morgan 336-716-2513 armorgan@wakehealth.edu
Contact: Phyllis Babcock 336-713-8542 pbabcock@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27104
Contact: Christina Hugenschmidt, PhD    336-713-8116    chugensc@wakehealth.edu   
Sponsors and Collaborators
Wake Forest University Health Sciences
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Christina Hugenschmidt, PhD Assistant Professor Gerontology and Geriatric Medicine
Publications:
Committee, S.o.t.F., State of the Field Report: Arts in Healthcare 2009, 2009, Society for the Arts in Healthcare: Washington, DC.
Hackney, M.E., S. Kantorovich, and G.M. Earhart, A study of the effects of Argentine tango as a form of partnered dance for those with Parkinson disease and the healthy elderly. American Journal of Dance Therapy, 2007. 29(2): p. 109-127.
Westheimer, O., Why dance for Parkinson's disease? Topics in Geriatric Rehabilitation, 2008. 24(2): p. 127-140.
Haboush, A., et al., Ballroom dance lessons for geriatric depression: An exploratory study. The Arts in Psychotherapy, 2006. 33(2): p. 89-97.
Brauninger, I., The efficacy of dance movement therapy group on improvement of quality of life: A randomized controlled trial. The Arts in Psychotherapy, 2012. 39: p. 296-303.
Goldman, D., I want to be ready: Improvised dance as a practice of freedom. 2010, Ann Arbor, MI: University of Michigan Press.
Montuori, A., The complexity of improvisation and the improvisation of complexity: Social science, art and creativity. Human Relations, 2003. 56(2): p. 237-255.
Lockford, L. and R. Pelias, Bodily poeticizing in theatrical improvisation: A typology of performative knowledge. Theatre Topics, 2004. 14(2): p. 431-443.
Sawyer, R., Improvisation and the creative process: Dewey, Collingwood, and the aesthetics of spontaneity. Journal of Aesthetics and Art Criticism, 2000. 58(2): p. 149-161.
Batson, G., et al., Effects of improvisational dance on balance in Parkinson's disease: A two-phase fMRI case study. Physical and Occupational Therapy in Geriatrics, 2014. 32(3): p. 188-197.
Dziak, J.J., L.M. Collins, and A.T. Wagner, FactorialPowerPlan SAS macro suite users' guide (Version 1.0). University Park: The Methodology Center, Penn State, 2013. Retrieved from http://methodology.psy.edu.
Costa, P.T. and R.R. McCrae, The NEO-PI/NEO-FFI manual supplement. 1989, Odessa, FL: Psychological Assessment Resources.
Kattenstroth, J.C., et al., Dance Therapy for Cognitive Enhancement in the Elderly. Journal of Psychophysiology, 2011. 25: p. 17-17.
Bollen, K.A., Structural equations with latent variables. 1989, Hoboken, NJ: Wiley.

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03333837    
Other Study ID Numbers: IRB00042460
R01AT009444 ( U.S. NIH Grant/Contract )
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Improvisation
Memory loss
Caregivers
Quality of Life
Dance
Social Group
MRI
mild cognitive impairment
MCI
Social engagement
Additional relevant MeSH terms:
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Alzheimer Disease
Memory Disorders
Amnesia
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Neurobehavioral Manifestations
Neurologic Manifestations