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Yoga for Caregivers and Persons With Dementia

A Pilot Study Yoga for Caregivers and Persons With Dementia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05103839
Acronym
YCPD
Enrollment
4
Registered
2021-11-02
Start date
2022-05-02
Completion date
2022-08-04
Last updated
2024-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Keywords

dyad, caregiver, yoga, dementia

Brief 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.

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.

Interventions

BEHAVIORALGentle Yoga

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.

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Non-English-speaking; and practicing yoga or meditation within the last 30 days.

Design outcomes

Primary

MeasureTime frameDescription
Percentage Adherence to Intervention Sessions--Persons with DementiaWeek 10Number of sessions attended/Total number of sessions offered
Retention Percentage--CaregiversWeek 10Number of people who complete the Week 10 assessment/Total Number Enrolled
Retention Percentage--Persons With DementiaWeek 10Number of people who complete the Week 10 assessment/Total Number Enrolled
Percentage Adherence to Intervention Sessions--CaregiversWeek 10Number of sessions attended/Total number of sessions offered
Accrual Percentage--CaregiversBaselineNumber of people randomized/Number of people approached about the study
Accrual Percentage--Persons with DementiaBaselineNumber of people randomized/Number of people approached about the study

Secondary

MeasureTime frameDescription
PROMIS Depression--Persons with DementiaBaseline, Week 108-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.
PROMIS Depression--CaregiversBaseline, Week 108-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.
PROMIS Self-efficacy for Managing Emotions--CaregiversBaseline, Week 108-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.
Neuropsychiatric Inventory Questionnaire--SeverityBaseline, Week 10Completed 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.
Neuropsychiatric Inventory Questionnaire--DistressBaseline, Week 10Completed 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
Insomnia Sleep Index--Persons with DementiaBaseline, Week 107-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
Insomnia Sleep Index--CaregiversBaseline, Week 107-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
PROMIS Self-efficacy for Managing Emotions--Persons with DementiaBaseline, Week 108-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.
Client Satisfaction Questionnaire--Persons With DementiaWeek 108-item measure of satisfaction with the intervention. Scores can range from 8 to 32; higher scores indicate more satisfaction.
Client Satisfaction Questionnaire--CaregiversWeek 108-item measure of satisfaction with the intervention. Scores can range from 8 to 32; higher scores indicate more satisfaction.
Zarit Burden InterviewBaseline, Week 10Completed by caregiver. 22-item measure of caregiver burden. Scores range from 0 to 88, with higher scores indicating greater caregiver burden.
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety--Persons with DementiaBaseline, Week 108-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.
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety--CaregiversBaseline, Week 108-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.

Other

MeasureTime frameDescription
Percentage Adherence to Independent Practice--Persons With DementiaWeek 10Number of sessions of independent practice/Total number of recommended independent practice sessions (4X/week)
Average Minutes of Yoga Practice per Day--CaregiversFrom Baseline through Week 10Collected from self-reported yoga/stretching log
Average Minutes of Yoga Practice per Day--Persons With DementiaFrom Baseline through Week 10Collected from self-reported yoga/stretching log
Qualitative QuestionsBaseline, Week 10Completed by caregivers. Any changes they noticed, motivation for engaging in yoga, barriers. Interview responses will be reviewed and common themes will be extracted.
Percentage Adherence to Independent Practice--CaregiversWeek 10Number of sessions of independent practice/Total number of recommended independent practice sessions (4X/week)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026