DementiaYCPDNCT05103839
Yoga for Caregivers and Persons With Dementia
A study testing Gentle Yoga in people with Dementia, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research is to determine the feasibility and acceptability of yoga classes for persons living with dementia (PLWD) and their care partners. A secondary aim of this study is to examine the impact of yoga on caregiver burden. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Gentle Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2022to 4 Aug 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caregivers: Providing unpaid care to a family member of friend diagnosed Alzheimer's Disease and Alzheimer's Disease Related Dementias (ADRD)
- Persons with dementia: A diagnosis of dementia; live in the community (assisted living facility is allowed); cognitively able to participate in yoga as determined by study staff
Who cannot join
- Non-English-speaking; and practicing yoga or meditation within the last 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
Official title: A Pilot Study Yoga for Caregivers and Persons With Dementia
The purpose of this research is to determine the feasibility and acceptability of yoga classes for persons living with dementia (PLWD) and their care partners. A secondary aim of this study is to examine the impact of yoga on caregiver burden.
Read the detailed description
Participants will be recruited from the D-Care Study in dyads. Both the caregiver and person with dementia must agree to participate. Screening will be done either in clinics or by telephone in the participants' homes. The intervention will be conducted in community facilities and participants' homes. The sample size will consist of 10 caregiver/person with dementia dyads. This number was chosen to provide evidence of feasibility of conducting yoga classes with dyads.
- Conditions
- Dementia
- Being tested
- Gentle Yoga
- Keywords
- dyad, caregiver, yoga, dementia
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentle YogaBehavioural
Yoga classes are twice a week for up to 10 weeks with a trained yoga instructor at a location in the community. Classes will last up to 75 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Yoga for Caregivers and Persons With Dementia | Experimental | Persons With Dementia and their caregivers will participate in up to 20 group yoga classes. Receives: Behavioral: Gentle Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual Percentage--Persons with Dementia
Number of people randomized/Number of people approached about the study
Measured: Baseline
Accrual Percentage--Caregivers
Number of people randomized/Number of people approached about the study
Measured: Baseline
Percentage Adherence to Intervention Sessions--Persons with Dementia
Number of sessions attended/Total number of sessions offered
Measured: Week 10
Percentage Adherence to Intervention Sessions--Caregivers
Number of sessions attended/Total number of sessions offered
Measured: Week 10
Retention Percentage--Persons With Dementia
Number of people who complete the Week 10 assessment/Total Number Enrolled
Measured: Week 10
Retention Percentage--Caregivers
Number of people who complete the Week 10 assessment/Total Number Enrolled
Measured: Week 10
Secondary outcomes (13)
Client Satisfaction Questionnaire--Persons With Dementia
8-item measure of satisfaction with the intervention. Scores can range from 8 to 32; higher scores indicate more satisfaction.
Measured: Week 10
Client Satisfaction Questionnaire--Caregivers
8-item measure of satisfaction with the intervention. Scores can range from 8 to 32; higher scores indicate more satisfaction.
Measured: Week 10
Zarit Burden Interview
Completed by caregiver. 22-item measure of caregiver burden. Scores range from 0 to 88, with higher scores indicating greater caregiver burden.
Measured: Baseline, Week 10
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety--Persons with Dementia
8-item measure of anxiety symptoms 8-item measure of anxiety symptoms; responses are made on a 5-point Likert scale and converted to t-scores with a mean of 50 and standard deviation of 10; higher scores indicate greater severity of anxiety.
Measured: Baseline, Week 10
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety--Caregivers
8-item measure of anxiety symptoms 8-item measure of anxiety symptoms; responses are made on a 5-point Likert scale and converted to t-scores with a mean of 50 and SD of 10; higher scores indicate greater severity of anxiety.
Measured: Baseline, Week 10
PROMIS Depression--Persons with Dementia
8-item measure of depressive symptoms; responses are made on a 5-point Likert scale and converted to t-scores with a mean of 50 and SD of 10. higher scores indicate greater severity of depression.
Measured: Baseline, Week 10
PROMIS Depression--Caregivers
8-item measure of depressive symptoms; responses are made on a 5-point Likert scale and converted to t-scores with a mean of 50 and SD of 10. higher scores indicate greater severity of depression.
Measured: Baseline, Week 10
PROMIS Self-efficacy for Managing Emotions--Persons with Dementia
8-item measure of emotional regulation. Responses are made on a 5-point Likert scale and converted to t-scores with a mean of 50 and SD of 10 higher scores indicate greater self-efficacy.
Measured: Baseline, Week 10
PROMIS Self-efficacy for Managing Emotions--Caregivers
8-item measure of emotional regulation. Responses are made on a 5-point Likert scale and converted to t-scores with a mean of 50 and SD of 10 higher scores indicate greater self-efficacy.
Measured: Baseline, Week 10
Neuropsychiatric Inventory Questionnaire--Severity
Completed by caregivers. Severity and distress from 12 care recipient behavioral symptoms. Severity and distress from 12 care recipient behavioral symptoms are rated. Severity is rated on 3 point Likert scale and scores range from 12-36, with higher scores indicating greater severity.
Measured: Baseline, Week 10
Neuropsychiatric Inventory Questionnaire--Distress
Completed by caregivers. Severity and distress from 12 care recipient behavioral symptoms. Severity and distress from 12 care recipient behavioral symptoms are rated. Distress is rated on a 6 point Likert scale and scores range from 0 to 60, with higher scores indicating greater distress
Measured: Baseline, Week 10
Insomnia Sleep Index--Persons with Dementia
7-item self-report measure of type and severity of insomnia symptoms. 7-item measure of type and severity of insomnia symptoms; responses are made on a 5-point Likert scale and summed, with higher scores indicating greater insomnia; scores range from 0 to 28
Measured: Baseline, Week 10
Insomnia Sleep Index--Caregivers
7-item self-report measure of type and severity of insomnia symptoms. 7-item measure of type and severity of insomnia symptoms; responses are made on a 5-point Likert scale and summed, with higher scores indicating greater insomnia; scores range from 0 to 28
Measured: Baseline, Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start2 May 2022
- Primary completion4 Aug 2022
- Study completion4 Aug 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.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gretchen Brenes, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103839
- Sponsor's protocol ID
- IRB00077146
- Acronym
- YCPD
- Status last verified
- Dec 2023
- First submitted
- 21 Oct 2021
- Last updated
- 13 Feb 2024
- 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 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Yoga for Caregivers and Persons With Dementia
- ClinicalTrials.gov ID
- NCT05103839
- Acronym / sponsor ID
- YCPD / IRB00077146
- Conditions
- Dementia
- Keywords
- dyad, caregiver, yoga, dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 4 Aug 2022 (actual)
- Study completion
- 4 Aug 2022 (actual)
- First posted
- 2 Nov 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.
The purpose of this research is to determine the feasibility and acceptability of yoga classes for persons living with dementia (PLWD) and their care partners. A secondary aim of this study is to examine the impact of yoga on caregiver burden.
Detailed description
Participants will be recruited from the D-Care Study in dyads. Both the caregiver and person with dementia must agree to participate. Screening will be done either in clinics or by telephone in the participants' homes. The intervention will be conducted in community facilities and participants' homes. The sample size will consist of 10 caregiver/person with dementia dyads. This number was chosen to provide evidence of feasibility of conducting yoga classes with dyads.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga for Caregivers and Persons With Dementia | Experimental | Behavioral: Gentle YogaPersons With Dementia and their caregivers will participate in up to 20 group yoga classes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Caregivers: Providing unpaid care to a family member of friend diagnosed Alzheimer's Disease and Alzheimer's Disease Related Dementias (ADRD)
- Persons with dementia: A diagnosis of dementia; live in the community (assisted living facility is allowed); cognitively able to participate in yoga as determined by study staff
Key exclusion criteria (1 listed)
- Non-English-speaking; and practicing yoga or meditation within the last 30 days.
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 |
|---|---|---|
| Gentle YogaYoga classes are twice a week for up to 10 weeks with a trained yoga instructor at a location in the community. Classes will last up to 75 minutes. | Behavioural | Yoga for Caregivers and Persons With Dementia |
Primary outcome
Accrual Percentage--Persons with Dementia
Time frame: Baseline
Number of people randomized/Number of people approached about the study
Accrual Percentage--Caregivers
Time frame: Baseline
Number of people randomized/Number of people approached about the study
Percentage Adherence to Intervention Sessions--Persons with Dementia
Time frame: Week 10
Number of sessions attended/Total number of sessions offered
Percentage Adherence to Intervention Sessions--Caregivers
Time frame: Week 10
Number of sessions attended/Total number of sessions offered
Retention Percentage--Persons With Dementia
Time frame: Week 10
Number of people who complete the Week 10 assessment/Total Number Enrolled
Retention Percentage--Caregivers
Time frame: Week 10
Number of people who complete the Week 10 assessment/Total Number Enrolled
13 secondary outcomes
Client Satisfaction Questionnaire--Persons With Dementia
Time frame: Week 10
Client Satisfaction Questionnaire--Caregivers
Time frame: Week 10
Zarit Burden Interview
Time frame: Baseline, Week 10
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety--Persons with Dementia
Time frame: Baseline, Week 10
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety--Caregivers
Time frame: Baseline, Week 10
PROMIS Depression--Persons with Dementia
Time frame: Baseline, Week 10
PROMIS Depression--Caregivers
Time frame: Baseline, Week 10
PROMIS Self-efficacy for Managing Emotions--Persons with Dementia
Time frame: Baseline, Week 10
PROMIS Self-efficacy for Managing Emotions--Caregivers
Time frame: Baseline, Week 10
Neuropsychiatric Inventory Questionnaire--Severity
Time frame: Baseline, Week 10
Neuropsychiatric Inventory Questionnaire--Distress
Time frame: Baseline, Week 10
Insomnia Sleep Index--Persons with Dementia
Time frame: Baseline, Week 10
Insomnia Sleep Index--Caregivers
Time frame: Baseline, Week 10
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 13 Feb 2024.
- 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.
Gretchen Brenes, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gentle Yoga in people with Dementia, run by Wake Forest University Health Sciences at 1 site in United States.
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 2 inclusion and 1 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 13 Feb 2024. 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 United States. 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?
Accrual Percentage--Persons with Dementia (time frame: Baseline). The study lists 6 primary outcomes in all. 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 13 Feb 2024.