Yoga for Caregivers and Persons With Dementia (YCPD)

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.

Study Overview

• Status: Completed
• Conditions: Dementia
• Intervention / Treatment: Behavioral: Gentle Yoga

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yoga for Caregivers and Persons With Dementia; Persons With Dementia and their caregivers will participate in up to 20 group yoga classes.	Behavioral: Gentle 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Gretchen Brenes, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Actual): August 4, 2022
• Study Completion (Actual): August 4, 2022

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (Actual): November 2, 2021

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: dementia; yoga; dyad; caregiver
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: IRB00077146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No