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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yoga for Caregivers and Persons With Dementia | Experimental | Persons With Dementia and their caregivers will participate in up to 20 group yoga classes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gentle Yoga | Behavioral | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accrual Percentage--Persons with Dementia | Number of people randomized/Number of people approached about the study | Baseline |
| Accrual Percentage--Caregivers | Number of people randomized/Number of people approached about the study | Baseline |
| Percentage Adherence to Intervention Sessions--Persons with Dementia | Number of sessions attended/Total number of sessions offered | Week 10 |
| Percentage Adherence to Intervention Sessions--Caregivers | Number of sessions attended/Total number of sessions offered | Week 10 |
| Retention Percentage--Persons With Dementia | Number of people who complete the Week 10 assessment/Total Number Enrolled | Week 10 |
| Retention Percentage--Caregivers | Number of people who complete the Week 10 assessment/Total Number Enrolled | Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 10 |
| Client Satisfaction Questionnaire--Caregivers |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Adherence to Independent Practice--Persons With Dementia | Number of sessions of independent practice/Total number of recommended independent practice sessions (4X/week) | Week 10 |
| Percentage Adherence to Independent Practice--Caregivers |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gretchen Brenes, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 27, 2023 | Feb 8, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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8-item measure of satisfaction with the intervention. Scores can range from 8 to 32; higher scores indicate more satisfaction.
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | Baseline, Week 10 |
Number of sessions of independent practice/Total number of recommended independent practice sessions (4X/week)
| Week 10 |
| Qualitative Questions | Completed by caregivers. Any changes they noticed, motivation for engaging in yoga, barriers. Interview responses will be reviewed and common themes will be extracted. | Baseline, Week 10 |
| Average Minutes of Yoga Practice per Day--Persons With Dementia | Collected from self-reported yoga/stretching log | From Baseline through Week 10 |
| Average Minutes of Yoga Practice per Day--Caregivers | Collected from self-reported yoga/stretching log | From Baseline through Week 10 |
| D001523 | Mental Disorders |