Yoga for Caregivers and Persons With Dementia

Dementia Clinical Trial

— YCPD  

Official title:

A Pilot Study Yoga for Caregivers and Persons With Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05103839
• Other study ID #: IRB00077146
• Status: Completed
• Phase: N/A
• Start date: May 2, 2022
• Est. completion date: August 4, 2022

Study information

• Verified date: December 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: August 4, 2022
• Est. primary completion date: August 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dementia

Intervention

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.

Locations

Country	Name	City	State
United States	Atrium Health Wake Forest Baptist	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Percentage Adherence to Independent Practice--Caregivers	Number of sessions of independent practice/Total number of recommended independent practice sessions (4X/week)	Week 10
Other	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
Other	Average Minutes of Yoga Practice per Day--Persons With Dementia	Collected from self-reported yoga/stretching log	From Baseline through Week 10
Other	Average Minutes of Yoga Practice per Day--Caregivers	Collected from self-reported yoga/stretching log	From Baseline through Week 10
Primary	Accrual Percentage--Persons with Dementia	Number of people randomized/Number of people approached about the study	Baseline
Primary	Accrual Percentage--Caregivers	Number of people randomized/Number of people approached about the study	Baseline
Primary	Percentage Adherence to Intervention Sessions--Persons with Dementia	Number of sessions attended/Total number of sessions offered	Week 10
Primary	Percentage Adherence to Intervention Sessions--Caregivers	Number of sessions attended/Total number of sessions offered	Week 10
Primary	Retention Percentage--Persons With Dementia	Number of people who complete the Week 10 assessment/Total Number Enrolled	Week 10
Primary	Retention Percentage--Caregivers	Number of people who complete the Week 10 assessment/Total Number Enrolled	Week 10
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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