- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04884529
Virtual Chair Yoga for Older Adults and Caregivers: Randomized Controlled Trial
Virtual Chair Yoga for Stress in Older Adults (60+) With Mild/Moderate Dementia or Mild Cognitive Impairments and Caregivers (18+) During COVID-19
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
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Montreal, Quebec, Canada, H3T 1E4
- Institute of Community and Family Psychiatry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
8-week chair yoga program with gentle postures, breathing techniques, and mindfulness.
|
No Intervention: 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in perceived stress scores as measured by the Perceived Stress Scale (PSS) for treatment group versus control group
Time Frame: 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. |
Baseline, 8-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in loneliness scores as measured by the 3-item UCLA Loneliness Scale for treatment group versus control group
Time Frame: 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.
|
Baseline, 8-weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in caregiver burden as measured by the Zarit Burden Interview (ZBI) for treatment group versus control group
Time Frame: 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 caregiver burden in caregivers, using the ZBI. Scores on the ZBI can range from 0-88, with higher scores corresponding to higher levels of burden. Hypothesis 1: Following participation in an 8-week RCT of the virtual chair yoga program, caregivers of older adults will report less caregiver burden, as measured by the Zarit Burden Interview (ZBI) compared to the waitlist control group. Hypothesis 2: Lower scores for older adults on the PHQ-9 and GAD-7 (week 8) will be associated with decreased caregiver burden following participation in an 8-week RCT of the virtual chair yoga program. |
Baseline, 8-weeks
|
Changes in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9) for treatment group versus control group
Time Frame: 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 depressive symptoms in older adults and caregivers, using the PHQ-9. Scores on the PHQ-9 can range from 0-27, with higher scores indicating more severe depression. Hypothesis: Following participation in an 8-week RCT of the virtual chair yoga program, older adults with dementia and their caregivers will report less depressive symptoms, as measured by the Patient Health Questionnaire (PHQ-9) compared to the waitlist 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
Time Frame: 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 symptoms of anxiety in older adults and caregivers, using the GAD-7. Scores on the GAD-7 range from 0-21, with higher scores indicating more severe anxiety. Hypothesis: Following participation in an 8-week RCT of the virtual chair yoga program, older adults with dementia and their caregivers will report less symptoms of anxiety, as measured by the Generalized Anxiety Disorder 7-Item Scale (GAD-7) compared to the waitlist control group. |
Baseline, 8-weeks
|
Changes in fear of COVID-19 as measured by the Fear of COVID-19 scale (FC-19S) for treatment group versus control group
Time Frame: 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 fear of COVID-19 in older adults and caregivers, using the FC-19S. Scores on the FC-19S range from 7-35, with higher scores indicating more fear of COVID-19. Hypothesis: Following participation in an 8-week RCT of the virtual chair yoga program, older adults with dementia and their caregivers will report less fear of COVID-19, as measured by the Fear of COVID-19 scale (FC-19S) compared to the waitlist control group. |
Baseline, 8-weeks
|
Semi-structured interviews/focus groups for the Qualitative Component
Time Frame: 8-weeks
|
The 8-week randomized controlled trial (RCT) of the virtual chair yoga treatment versus the waitlist control group will assess lived experiences and perceptions from baseline to 8-weeks in the form of interview/focus groups.
|
8-weeks
|
Changes in mindfulness as measured by the 5 Facet Mindfulness Questionnaire: Short form (FFMQ-SF) for treatment group versus control group.
Time Frame: 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 levels of mindfulness in older adults and caregivers, using the FFMQ-SF. Scores on the FFMQ-SF range from 0-120, with higher scores indicating higher levels of mindfulness. Hypothesis: Following participation in an 8-week RCT of the virtual chair yoga program, older adults with dementia and their caregivers will report higher levels of mindfulness, as measured by the 5 Facet Mindfulness Questionnaire: Short form (FFMQ-SF) compared to the waitlist control group. |
Baseline, 8-weeks
|
Changes in levels of self-compassion as measured by the Self-Compassion Scale-Short Form (SCS-SF) for treatment group versus control group.
Time Frame: 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 levels of self-compassion in older adults and caregivers, using the SCS-SF. Scores on the SCS-SF range from 0-60, with higher scores indicating higher levels of self-compassion. Hypothesis: Following participation in an 8-week RCT of the virtual chair yoga program, older adults with dementia and their caregivers will report higher levels self-compassion, as measured by the Self-Compassion Scale-Short Form (SCS-SF) compared to the waitlist control group. |
Baseline, 8-weeks
|
Changes in levels of rejection sensitivity as measured by the Rejection Sensitivity Questionnaire - Adult Version (A-RSQ) for treatment group versus control group.
Time Frame: 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 rejection sensitivity in older adults and caregivers, using the A-RSQ. Hypothesis: Following participation in an 8-week RCT of the virtual chair yoga program, older adults with dementia and their caregivers will report less sensitivity to rejection, as measured by the Rejection Sensitivity Questionnaire - Adult Version (A-RSQ) compared to the waitlist control group. |
Baseline, 8-weeks
|
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.
Time Frame: 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 levels of social pleasure and positive emotions in older adults and caregivers, using the SSPS. Hypothesis: Following participation in an 8-week RCT of the virtual chair yoga program, older adults with dementia and their caregivers will report higher levels of social pleasure and positive emotions, as measured by the Social Safeness and Pleasure Scale (SSPS) compared to the waitlist control group. |
Baseline, 8-weeks
|
Changes in perceptions of social connectedness as measured by the Social Connectedness Scale-Revised (SCS) for treatment group versus control group.
Time Frame: 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 perceptions of social connectedness in the individuals social environment for older adults and caregivers, using the SCS. Hypothesis: Following participation in an 8-week RCT of the virtual chair yoga program, older adults with dementia and their caregivers will report higher perceptions of social connectedness in their environment, as measured by the Social Connectedness Scale-Revised (SCS) compared to the waitlist control group. |
Baseline, 8-weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-2761
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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