Yoga for Caregivers and Persons With Dementia

Not Applicable

Completed

• Conditions: Dementia
• Interventions: Behavioral: Gentle Yoga

• Registration Number: NCT05103839
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-10-21
• Study First Posted: 2021-11-02
• Study Start: 2022-05-02
• Primary Completion: 2022-08-04
• Study Completion: 2022-08-04
• Status Verified: 2023-12
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Yoga for Caregivers and Persons With Dementia	Gentle Yoga	Persons With Dementia and their caregivers will participate in up to 20 group yoga classes.

Primary Outcome Measures

Name	Time	Method
Percentage Adherence to Intervention Sessions--Persons with Dementia	Week 10	Number of sessions attended/Total number of sessions offered
Accrual Percentage--Persons with Dementia	Baseline	Number of people randomized/Number of people approached about the study
Retention Percentage--Caregivers	Week 10	Number of people who complete the Week 10 assessment/Total Number Enrolled
Accrual Percentage--Caregivers	Baseline	Number of people randomized/Number of people approached about the study
Percentage Adherence to Intervention Sessions--Caregivers	Week 10	Number of sessions attended/Total number of sessions offered
Retention Percentage--Persons With Dementia	Week 10	Number of people who complete the Week 10 assessment/Total Number Enrolled

Secondary Outcome Measures

Name	Time	Method
Client Satisfaction Questionnaire--Caregivers	Week 10	8-item measure of satisfaction with the intervention. Scores can range from 8 to 32; higher scores indicate more satisfaction.
Zarit Burden Interview	Baseline, Week 10	Completed by caregiver. 22-item measure of caregiver burden. Scores range from 0 to 88, with higher scores indicating greater caregiver burden.
PROMIS Depression--Persons with Dementia	Baseline, Week 10	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.
Client Satisfaction Questionnaire--Persons With Dementia	Week 10	8-item measure of satisfaction with the intervention. Scores can range from 8 to 32; higher scores indicate more satisfaction.
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety--Caregivers	Baseline, Week 10	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.
PROMIS Depression--Caregivers	Baseline, Week 10	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.
PROMIS Self-efficacy for Managing Emotions--Persons with Dementia	Baseline, Week 10	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.
Insomnia Sleep Index--Persons with Dementia	Baseline, Week 10	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
Insomnia Sleep Index--Caregivers	Baseline, Week 10	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
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety--Persons with Dementia	Baseline, Week 10	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.
Neuropsychiatric Inventory Questionnaire--Severity	Baseline, Week 10	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.
PROMIS Self-efficacy for Managing Emotions--Caregivers	Baseline, Week 10	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.
Neuropsychiatric Inventory Questionnaire--Distress	Baseline, Week 10	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

Trial Locations

Locations (1)

Atrium Health Wake Forest Baptist; 🇺🇸 Winston-Salem, North Carolina, United States