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Completed

NCT Number: NCT05103839

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Accrual Percentage--Persons with Dementia

    Time frame: Baseline

    Number of people randomized/Number of people approached about the study

  2. Accrual Percentage--Caregivers

    Time frame: Baseline

    Number of people randomized/Number of people approached about the study

  3. Percentage Adherence to Intervention Sessions--Persons with Dementia

    Time frame: Week 10

    Number of sessions attended/Total number of sessions offered

  4. Percentage Adherence to Intervention Sessions--Caregivers

    Time frame: Week 10

    Number of sessions attended/Total number of sessions offered

  5. Retention Percentage--Persons With Dementia

    Time frame: Week 10

    Number of people who complete the Week 10 assessment/Total Number Enrolled

  6. Retention Percentage--Caregivers

    Time frame: Week 10

    Number of people who complete the Week 10 assessment/Total Number Enrolled

Secondary outcomes

  1. Client Satisfaction Questionnaire--Persons With Dementia

    Time frame: Week 10

    8-item measure of satisfaction with the intervention. Scores can range from 8 to 32; higher scores indicate more satisfaction.

  2. Client Satisfaction Questionnaire--Caregivers

    Time frame: Week 10

    8-item measure of satisfaction with the intervention. Scores can range from 8 to 32; higher scores indicate more satisfaction.

  3. Zarit Burden Interview

    Time frame: 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.

  4. Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety--Persons with Dementia

    Time frame: 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.

  5. Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety--Caregivers

    Time frame: 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.

  6. PROMIS Depression--Persons with Dementia

    Time frame: 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.

  7. PROMIS Depression--Caregivers

    Time frame: 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.

  8. PROMIS Self-efficacy for Managing Emotions--Persons with Dementia

    Time frame: 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.

  9. PROMIS Self-efficacy for Managing Emotions--Caregivers

    Time frame: 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.

  10. Neuropsychiatric Inventory Questionnaire--Severity

    Time frame: 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.

  11. Neuropsychiatric Inventory Questionnaire--Distress

    Time frame: 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

  12. Insomnia Sleep Index--Persons with Dementia

    Time frame: 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

  13. Insomnia Sleep Index--Caregivers

    Time frame: 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

Other outcomes

  1. Percentage Adherence to Independent Practice--Persons With Dementia

    Time frame: Week 10

    Number of sessions of independent practice/Total number of recommended independent practice sessions (4X/week)

  2. Percentage Adherence to Independent Practice--Caregivers

    Time frame: Week 10

    Number of sessions of independent practice/Total number of recommended independent practice sessions (4X/week)

  3. Qualitative Questions

    Time frame: Baseline, Week 10

    Completed by caregivers. Any changes they noticed, motivation for engaging in yoga, barriers. Interview responses will be reviewed and common themes will be extracted.

  4. Average Minutes of Yoga Practice per Day--Persons With Dementia

    Time frame: From Baseline through Week 10

    Collected from self-reported yoga/stretching log

  5. Average Minutes of Yoga Practice per Day--Caregivers

    Time frame: From Baseline through Week 10

    Collected from self-reported yoga/stretching log

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

A Pilot Study Yoga for Caregivers and Persons With Dementia

Acronym: YCPD

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 2, 2021
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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