DementiaNCT04884529
Virtual Chair Yoga for Older Adults and Caregivers: Randomized Controlled Trial
A study testing Chair-yoga program in people with Dementia and Mild Cognitive Impairment, run by Lady Davis Institute at 1 site 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 olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Mild Cognitive Impairment
- What is being tested?
- Chair-yoga program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2021to 30 Mar 2022
- 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
- Healthy volunteers accepted
- 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
1 site in 1 country.
Canada1 site
Institute of Community and Family Psychiatry
Montreal, Quebec, H3T 1E4
About this study
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
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
- Being tested
- Chair-yoga program
- Keywords
- Dementia, Mild Cognitive Impairments, Caregiving, Stress, Loneliness, Depression, Anxiety, Chair-yoga
- Medical subject headings
- Dementia, Cognitive Dysfunction, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chair-yoga programBehavioural
8-week chair yoga program with gentle postures, breathing techniques, and mindfulness.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
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.
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 posted13 May 2021
- Study start1 Sep 2021
- Primary completion30 Dec 2021
- Study completion30 Mar 2022
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- 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
- NCT04884529
- Sponsor's protocol ID
- 2021-2761
- Status last verified
- Apr 2022
- First submitted
- 7 May 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04884529
- Acronym / sponsor ID
- 2021-2761
- Conditions
- Dementia, Mild Cognitive Impairment
- Keywords
- Dementia, Mild Cognitive Impairments, Caregiving, Stress, Loneliness, Depression, Anxiety, Chair-yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lady Davis InstituteUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 13 May 2021 (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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chair Yoga Treatment Group | Experimental | Behavioral: Chair-yoga programThe 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. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- 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 |
|---|---|---|
| Chair-yoga program8-week chair yoga program with gentle postures, breathing techniques, and mindfulness. | Behavioural | Chair Yoga Treatment 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chair-yoga program in people with Dementia and Mild Cognitive Impairment, run by Lady Davis Institute at 1 site 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: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 6 Apr 2022.