Virtual Chair Yoga for Older Adults and Caregivers: Randomized Controlled Trial

NCT ID: NCT04884529

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-03-30

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.

Conditions

Dementia; Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Chair Yoga Treatment Group

The chair-yoga session will occur for 8-weeks (60 minutes/week) on Zoom. The chair-yoga intervention will include gentle seated postures, relaxation using breathing techniques, and a mindfulness component.

Group Type: EXPERIMENTAL

Chair-yoga program

Intervention Type: BEHAVIORAL

8-week chair yoga program with gentle postures, breathing techniques, and mindfulness.

Waitlist Control Group

These participants will be on a waitlist to receive the chair yoga program after data collection has been completed (e.g., after 8-weeks).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Chair-yoga program

8-week chair yoga program with gentle postures, breathing techniques, and mindfulness.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Severe dementia (MoCA-BLIND score < 8)
• Acute psychotic symptoms
• Acute suicidal ideation or intent
• Resides outside of Quebec

• Dementia (MoCA-BLIND score < 18)
• Acute psychotic symptoms
• Acute suicidal ideation or intent
• Resides outside of Quebec

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lady Davis Institute

OTHER

Sponsor Role: lead

Responsible Party

Soham Rej MD, MSc

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institute of Community and Family Psychiatry

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

2021-2761

Identifier Type: -

Identifier Source: org_study_id