跳至主要内容
临床试验/NCT03333837
NCT03333837已完成不适用

IMOVE: Improvisational Movement for People With Memory Loss and Their Caregivers

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2018年2月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
104
试验地点
2
主要终点
Quality of Life in Alzheimer's Disease (QOL-AD)--Participants With Dementia (PWD)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

All study assessments will be conducted by experienced staff certified annually on the proper conduct of study assessments and blinded to group assignment.

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

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

时间窗: Baseline

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.

QOL-AD--PWD

时间窗: Week 12

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.

次要结局

  • Local Efficiency (eLoc)--PWD(Week 12)
  • Geriatric Depression Scale(Week 12)
  • Fullerton Advanced Balance Scale (Overall Balance) PWD(Week 12)
  • Path Length--PWD(Week 12)
  • Neuropsychiatric Inventory Questionnaire (NPI-Q)(Baseline)
  • Community Structure--PWD(Week 12)
  • Geriatric Anxiety Scale(Week 12)
  • Global Efficiency (eGlob)--PWD(Week 12)
  • Gait Speed--PWD(Week 12)
  • Falls Efficacy Scale - International (FES) PWD(Week 12)
  • Apathy Evaluation Scale--PWD(Week 12)
  • Gait Variability--PWD(Week 12)
  • NPI-Q(Week 12)
  • Postural Sway--PWD(Week 12)
  • Expanded Short Physical Performance Battery (eSPPB)(Week 12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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