跳至主要内容
临床试验/NCT02403752
NCT02403752已完成不适用

Paired Integrative Home Exercise for Seniors With Dementia and Their Caregivers

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Change in Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) from baseline to 4 months

研究概览

简要总结

Specific Aim 1: To determine feasibility of a 20-minute dyadic exercise program for ambulatory individuals with dementia and caregivers living at home based on recruitment, adherence and retention. Investigators will conduct a pilot randomized controlled trial (RCT) with 20 dyads (total N = 40) in groups of 5 randomized to 16-week group exercise classes and regular home practice or wait list in a cross-over design. Investigators will assess feasibility of enrollment and retention, the proportion of completed outcome measures, and adherence by class attendance logs, caregiver-reported home practice logs and qualitative interviews to assess ease of implementation in the home environment. Investigators will explore feasibility of weekly phone calls to (potentially overwhelmed) caregivers and Fit-bit accelerometers as a measure for tracking home practice.

Specific Aim 2: To collect preliminary effect size data for sample size calculation for a larger trial. Investigators will assess standard outcomes (such as the Short Physical Performance Battery and Alzheimer's Disease Assessment Scale - cognitive subscale as primary outcomes for affected individuals; and Caregiver Burden Inventory for caregivers) commonly used in pharmacological studies of individuals with dementia at baseline, 16 and 32 weeks and calculate effect sizes (Cohen's d) for between-group differences in outcome changes in the 20 dyads of the RCT described in Specific Aim 1.

Specific Aim 3: To explore the feasibility of using non-invasive Near-Infrared Spectroscopy (NIRS) to assess regional cortical brain oxygenation and its sensitivity to change. Investigators will compare brain oxygenation variations before and after the exercise intervention during a memory task for the seniors with dementia.

详细描述

Alzheimer's dementia (AD) is a major public health challenge for our century. Research into pharmaceutical therapies has been disappointing and not provided any safe medications that can halt the disease's trajectory of decline in the cognitive, functional, emotional and social capabilities of the affected individuals. For non-pharmacological approaches, multi-domain exercise programs that address several of these capabilities in an integrated way have shown strong promise for their ability to slow the decline. The team of investigators has systematically developed one such program-the Preventing Loss of Independence through Exercise (PLIÉ) program-an integrative exercise program that uses procedural memory (memory for movements without explicit recall), can be taught at and integrated into senior day care centers and has been pilot-tested by our team with encouraging results for functional, cognitive and social outcomes (see Table 1).

However, (1) most people in the community do not have access to a day care center, are concerned about the stigma associated with day care or are unable to afford it. This was endorsed by semi-structured interviews conducted with caregivers and community-based organizations in preparation for a larger study of the PLIÉ program. There is a huge need for innovative programs to assist individuals with dementia and their caregivers in the community. Irrespective of having access to day care or not, motivated caregivers, who are aware of the benefits of exercises for their loved ones and spend hours alone with them at home, ask: "What can we do with our [e.g. mother]?" They point out a major lack of guidance for caregivers in the community to be able to use a regular exercise practice on a long-term basis at home. Caregivers and seniors with dementia living together in the community are dyads in need of a paired exercise program. (2) How exercise may delay cognitive and functional decline is unknown. One hypothetical mechanism of action is an improved brain oxygenation related to exercise. Near-Infrared Spectroscopy (NIRS) is a non-invasive method to assess regional cortical oxygenation levels, has been suggested for the early diagnosis of Alzheimer's dementia, but has never been applied to longitudinal studies in this population.

Paired home exercise programs for seniors with dementia and their primary caregivers have rarely been studied. A pilot study that used 6 'sticky hands' movement variations based on Tai Chi, music and exercise incentives found improvements in 2 outcome measures considered to be important in fall prevention (sit-to-stand time, one-legged stance time). However, movements were limited to tai chi and outcomes to fall-related function, leaving out cognitive function for which the PLIÉ program had shown such promising results.

The group of investigators is an established collaboration between the Osher Center for Integrative Medicine and the Department of Psychiatry at UCSF and has recently pioneered a novel, 45-minute, multi-domain program called Preventing Loss of Independence through Exercise (PLIÉ) that integrates physical activity (training of procedural memory for basic daily activities such as sitting and standing), cognitive stimulation (mindful body awareness), social engagement (group movement and sharing of in-the-moment experiences), and caregiver education (monthly home-visit). The investigators pilot-tested PLIÉ in 11 individuals with mild to moderate dementia who were attending an adult day program at the Institute of Aging in San Francisco, CA (ClinicalTrials.gov registered NCT01371214), and found (Table 1) preliminary evidence of medium to large, clinically meaningful effect sizes com-pared to usual care (UC; 45 minutes of usual chair-based exercises at the day care center) across a wide range of out-comes including measures of quality of life (0.83), cognitive function (0.76), physical performance (0.34) and caregiver burden (0.49).7,11 That study methodologically mimicked a drug study by including measures that are commonly used in dementia medication trials, which enabled comparison of the magnitude of our results to currently available dementia medications.. The investigators are now completing data collection for a second implementation of the PLIÉ program at an adult day program in San Rafael, CA (Senior Access). The intervention of the current proposal will be similar to PLIÉ in using the same principles6 and taught by instructors trained in the PLIÉ program. However, it will differ in its format: instead of a day-care center-based group program taught by professional exercise instructors, it uses a dyadic approach, introduced through caregiver support groups to pairs of individuals with dementia and their caregivers, initially using a group class format, but taught to enable caregivers to practice independently at home. To allow for wide-spread long-term routine application, it will be brief (20 minutes), use personalized music associated with positive affect memories, and be supported by video instructions.

2 papers have been published about the study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Affected individuals: dementia diagnosis (any type, mild to moderate severity [defined as independent in at least 1 basic ADL])
  • Ambulatory and able to take 2 steps without cane or walker
  • Living in the community in a private home or apartment
  • English language fluency.
  • Caregiver/care partner: lives with affected individual
  • Motivated to practice regularly (4-5 times per week) at home
  • Able to answer study questions related to the affected individual's functional status, mood, behaviors, quality of life and their own feelings regarding caregiving
  • English language fluency.

排除标准

  • Affected Individuals: behavioral or physical issues that would be disruptive or dangerous to themselves or others (e.g., active psychosis, drug abuse, severe behavioral issues)
  • Planning to move to a facility before the end of the study period
  • Terminal illness (life expectancy < 1 year)
  • Non-stable dementia medication dose
  • Current participation in another research study.
  • Caregiver/care partner: planning to place affected individual in an institutional setting during the study period
  • Terminal illness (life expectancy < 1 year)
  • Behavioral or physical issues that are disruptive or dangerous.

研究组 & 干预措施

exercise intervention

Experimental

Exercise protocol based on the PLIÉ protocol, developed in consultation with experts worldwide, incl. traditional strength-building exercises, yoga, Tai Chi and Feldenkrais, that engage the muscles most needed to maintain independence--including lower body strength, balance, upper body strength, fine motor exercises , and pelvic floor exercises- combined them into a unique integrative exercise program, to be purposeful and to build procedural ('muscle') memory.

To be practiced at home in dyads of affected individuals and caregivers, called Paired PLIE Program.

干预措施: Paired PLIE Program (Behavioral)

结局指标

主要结局

Change in Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) from baseline to 4 months

时间窗: Baseline, post-intervention (4 months)

We will perform a variety of standard measures in all participants and caregivers. Assessments will occur at baseline, after the 4 months of intervention, and at 8 months after follow-up of 4 months. Outcomes will primarily be utilized to assess feasibility and logistics of data collection procedures.

Change in Short Physical Performance Battery (SPPB) from Baseline to 4 months

时间窗: Baseline, post-intervention (4 months)

We will perform a variety of standard measures in all participants and caregivers. Assessments will occur at baseline, after the 4 months of intervention, and at 8 months after follow-up of 4 months. Outcomes will primarily be utilized to assess feasibility and logistics of data collection procedures.

次要结局

  • Change in Quality of Life Scale in Alzheimer's Disease (QOL-AD) from baseline to 4 months(Baseline, post-intervention (4 months))
  • Change in Caregiver Burden Inventory (CBI) from baseline to 4 months(Baseline, post-intervention (4 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验