跳至主要内容
临床试验/NCT04884529
NCT04884529已完成不适用

Virtual Chair Yoga for Stress in Older Adults (60+) With Mild/Moderate Dementia or Mild Cognitive Impairments and Caregivers (18+) During COVID-19

Lady Davis Institute2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Changes in perceived stress scores as measured by the Perceived Stress Scale (PSS) for treatment group versus control group

研究概览

简要总结

Over 700,000 Canadians are affected by dementia costing the health care system approximately $10 billion/year. Due to COVID-19, the government has urged individuals over the age of 70 to stay home, putting this population at risk of social isolation. Older adults with mild cognitive impairments (MCIs), dementia, and their caregivers are at an even higher risk of becoming stressed, anxious, and agitated while in lockdown. Unsurprisingly, caregiver burden is extremely common, and often precedes institutionalization of the patient, as the demands of the illness begin to exceed that which the caregiver can sustainably provide. Since social distancing measures have shut down activities and support groups for these individuals, there is an urgent need for scalable, cost-effective, non-pharmacological interventions that can be delivered remotely to improve stress and loneliness. Yoga may be a viable therapeutic modality to address the psychological challenges associated with dementia in patients and caregivers, as it has been shown to decrease stress and improve anxiety and depressive symptoms in various populations. For this reason, the investigators are conducting a randomized controlled trial (RCT) to assess the efficacy of an 8-week virtual chair yoga program to improve stress, psychological symptoms, and caregiver burden. This virtual chair yoga study will engage both older adults with dementia/MCI and caregivers (n=40-60 participants) during COVID-19, which is consistent with the need for decreasing costs and increasing accessibility of novel health interventions during and beyond the pandemic. The investigators will evaluate the effect of this program on stress, loneliness, and mental health related outcomes such as fear of COVID-19, depression, anxiety, and caregiver burden compared to a waitlist control group. There will also be a qualitative component in the form of semi-structured interviews. All quantitative outcomes will be assessed before the program starts and post-intervention and qualitative outcomes will be assessed post-intervention. Participants will be randomly assigned to the treatment group (virtual chair yoga 1 hour per week on Zoom) or the waitlist control group. The investigators hypothesize that after the 8-week yoga program, older adults and caregivers will report lower stress, loneliness, depression, anxiety, fear of COVID-19, and caregiver burden. Results will be available late-2021.

研究设计

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

盲法说明

Assessor will be blinded to participant randomization

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

  • for Older Adults:
  • Mild cognitive impairment or mild to moderate dementia (MoCA-BLIND score between 8-18 OR a diagnosis from his/her clinician of mild cognitive impairment) or mild to moderate dementia
  • Sufficient hearing to follow verbal instructions
  • Access to Zoom software and internet connection
  • Ability to sit for 60 minutes without discomfort
  • At least 60 years old

排除标准

  • for Older Adults:
  • Severe dementia (MoCA-BLIND score < 8)
  • Acute psychotic symptoms
  • Acute suicidal ideation or intent
  • Resides outside of Quebec
  • Inclusion Criteria for Caregivers:
  • Providing care for someone with cognitive impairments (mild cognitive impairment or mild, moderate, or severe dementia)
  • Sufficient hearing to follow verbal instructions
  • Access to Zoom software and internet connection
  • Ability to sit for 60 minutes without discomfort
  • At least 18 years old
  • Exclusion Criteria for Caregivers:
  • Dementia (MoCA-BLIND score < 18)
  • Acute psychotic symptoms
  • Acute suicidal ideation or intent
  • Resides outside of Quebec

结局指标

主要结局

Changes in perceived stress scores as measured by the Perceived Stress Scale (PSS) for treatment group versus control group

时间窗: Baseline, 8-weeks

The 8-week randomized controlled trial (RCT) of the virtual chair yoga treatment versus the waitlist control group will assess the effects of the virtual chair yoga on perceived stress in older adults and caregivers, using the PSS. Scores on the PSS can range from 0-40, with higher scores indicating higher perceived stress. Hypothesis: Following participation in an 8-week RCT of the virtual chair yoga program, older adults with dementia and their caregivers will report lower perceived stress, as measured by the Perceived Stress Scale (PSS) compared to the waitlist control group.

次要结局

  • Changes in loneliness scores as measured by the 3-item UCLA Loneliness Scale for treatment group versus control group(Baseline, 8-weeks)

研究者

发起方
Lady Davis Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Soham Rej MD, MSc

Primary Investigator

Lady Davis Institute

研究点 (2)

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