Clinical trial NCT04884529: Virtual Chair Yoga for Older Adults and Caregivers: Randomized Controlled Trial
Official title: Virtual Chair Yoga for Stress in Older Adults (60+) With Mild/Moderate Dementia or Mild Cognitive Impairments and Caregivers (18+) During COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Mild Cognitive Impairment
Keywords: Dementia
Mild Cognitive Impairments
Caregiving
Stress
Loneliness
Depression
Anxiety
Chair-yoga
Lead sponsor: Lady Davis Institute
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria 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

Exclusion Criteria 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

Primary outcomes:
measure: Changes in perceived stress scores as measured by the Perceived Stress Scale (PSS) for treatment group versus control group
timeFrame: Baseline, 8-weeks
Secondary outcomes:
measure: Changes in loneliness scores as measured by the 3-item UCLA Loneliness Scale for treatment group versus control group
timeFrame: Baseline, 8-weeks
Other outcomes:
measure: Changes in caregiver burden as measured by the Zarit Burden Interview (ZBI) for treatment group versus control group
timeFrame: Baseline, 8-weeks
measure: Changes in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9) for treatment group versus control group
timeFrame: Baseline, 8-weeks
measure: Changes in symptoms of anxiety as measured by the Generalized Anxiety Disorder-7 (GAD-7) scale for treatment group versus control group
timeFrame: Baseline, 8-weeks
measure: Changes in fear of COVID-19 as measured by the Fear of COVID-19 scale (FC-19S) for treatment group versus control group
timeFrame: Baseline, 8-weeks
measure: Semi-structured interviews/focus groups for the Qualitative Component
timeFrame: 8-weeks
measure: Changes in mindfulness as measured by the 5 Facet Mindfulness Questionnaire: Short form (FFMQ-SF) for treatment group versus control group.
timeFrame: Baseline, 8-weeks
measure: Changes in levels of self-compassion as measured by the Self-Compassion Scale-Short Form (SCS-SF) for treatment group versus control group.
timeFrame: Baseline, 8-weeks
measure: Changes in levels of rejection sensitivity as measured by the Rejection Sensitivity Questionnaire - Adult Version (A-RSQ) for treatment group versus control group.
timeFrame: Baseline, 8-weeks
measure: Changes in levels of social pleasure and positive emotions as measured by the Social Safeness and Pleasure Scale (SSPS) for treatment group versus control group.
timeFrame: Baseline, 8-weeks
measure: Changes in perceptions of social connectedness as measured by the Social Connectedness Scale-Revised (SCS) for treatment group versus control group.
timeFrame: Baseline, 8-weeks
Locations:
city: Montreal
country: Canada
facility: Institute of Community and Family Psychiatry
state: Quebec
Study officials:
References: