DementiaNCT04162964
Chair Yoga for Stress in Dementia
A study testing Virtual Chair Yoga in people with Dementia and Stress, run by Lady Davis Institute at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Virtual Chair Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- 27 Jan 2020to 13 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Institute of Community and Family Psychiatry
Montreal, Quebec, H3T 1E4
Douglas Mental Health University Institute
Montreal, Quebec, H4H 1R3
About this study
Official title: Effectiveness of a Virtual Chair Yoga Intervention for Reducing Stress in Older Adults With Dementia and Caregivers
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, we 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. We 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. We will also be conducting 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.
- Being tested
- Virtual Chair Yoga
- Keywords
- Dementia, Stress, Caregiving, Mind-body therapy, Anxiety, Depression
- Medical subject headings
- Dementia, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Chair YogaBehavioural
8-week virtual chair yoga program for one hour per week. Chair yoga is an effective way to offer modified yoga postures and relaxation techniques to individuals with limited mobility and/or advanced age for whom mat-based classes may not be accessible. The weekly yoga classes will be lead on the software Zoom by a certified instructor in English and French.
| Study group | Role | What they receive |
|---|---|---|
| Chair Yoga Treatment | Experimental | Not described Receives: Behavioral: Virtual Chair Yoga |
| Waitlist Control Group | Placebo comparator | Not described Receives: Behavioral: Virtual Chair Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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 UCLA Loneliness Scale can range from 3-9, with higher scores indicating higher loneliness.
Hypothesis: Following participation in an 8-week RCT of the virtual chair yoga program, older adults with dementia and their caregivers will report less loneliness, as measured by the UCLA Loneliness Scale compared to the waitlist control group.
Measured: Baseline, 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start27 Jan 2020
- Primary completion13 Mar 2021
- Study completion13 Mar 2021
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Davis Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soham Rej MD, MSc, Lady Davis Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162964
- Sponsor's protocol ID
- GeriPARTy
- Status last verified
- Sep 2020
- First submitted
- 29 Oct 2019
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Virtual Chair Yoga Intervention for Reducing Stress in Older Adults With Dementia and Caregivers
- ClinicalTrials.gov ID
- NCT04162964
- Acronym / sponsor ID
- GeriPARTy
- Keywords
- Dementia, Stress, Caregiving, Mind-body therapy, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lady Davis InstituteUniversity, hospital or other
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 13 Mar 2021 (actual)
- Study completion
- 13 Mar 2021 (actual)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, we 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. We 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. We will also be conducting 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chair Yoga Treatment | Experimental | Behavioral: Virtual Chair Yoga |
| Waitlist Control Group | Placebo comparator | Behavioral: Virtual Chair Yoga |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- Severe dementia (MoCA-BLIND score < 8)
- Acute psychotic symptoms
- Acute suicidal ideation or intent
- Resides outside of Quebec
- Dementia (MoCA-BLIND score < 18)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Chair Yoga8-week virtual chair yoga program for one hour per week. Chair yoga is an effective way to offer modified yoga postures and relaxation techniques to individuals with limited mobility and/or advanced age for whom mat-based classes may not be accessible. The weekly yoga classes will be lead on the software Zoom by a certified instructor in English and French. | Behavioural | Chair Yoga Treatment, Waitlist Control Group |
Primary outcome
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.
1 secondary outcome
Changes in loneliness scores as measured by the 3-item UCLA Loneliness Scale for treatment group versus control group
Time frame: Baseline, 8-weeks
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Chair Yoga in people with Dementia and Stress, run by Lady Davis Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in perceived stress scores as measured by the Perceived Stress Scale (PSS) for treatment group versus control group (time frame: Baseline, 8-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.