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

NCT04884529 | Completed DMC

• 1 other identifier: 2021-2761
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Dementia; Mild Cognitive Impairments; Caregiving; Stress; Loneliness; Depression; Anxiety; Chair-yoga

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline, 8-weeks

Secondary Outcomes (1)

• Changes in loneliness scores as measured by the 3-item UCLA Loneliness Scale for treatment group versus control group

  Baseline, 8-weeks

Other Outcomes (10)

• Changes in caregiver burden as measured by the Zarit Burden Interview (ZBI) for treatment group versus control group

  Baseline, 8-weeks

• Changes in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9) for treatment group versus control group

  Baseline, 8-weeks

• Changes in symptoms of anxiety as measured by the Generalized Anxiety Disorder-7 (GAD-7) scale for treatment group versus control group

  Baseline, 8-weeks

Study Arms (2)

Chair Yoga Treatment Group

EXPERIMENTAL

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.

Behavioral: Chair-yoga program

Waitlist Control Group

NO INTERVENTION

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

Interventions

Chair-yoga program BEHAVIORAL

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

Chair Yoga Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe dementia (MoCA-BLIND score \< 8)
• Acute psychotic symptoms
• Acute suicidal ideation or intent
• Resides outside of Quebec
• 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
• Dementia (MoCA-BLIND score \< 18)
• Acute psychotic symptoms
• Acute suicidal ideation or intent
• Resides outside of Quebec

Sponsors & Collaborators

• Lady Davis Institute: lead

Study Sites (1)

Institute of Community and Family Psychiatry

Montreal, Quebec, H3T 1E4, Canada

Location

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor will be blinded to participant randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 13, 2021
• Study Start: September 1, 2021
• Primary Completion: December 30, 2021
• Study Completion: March 30, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)