NCT05103839

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

May 2, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2022

Completed
Last Updated

February 13, 2024

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

October 21, 2021

Last Update Submit

February 8, 2024

Conditions

Keywords

dyadcaregiveryogadementia

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (13)

  • Client Satisfaction Questionnaire--Persons With Dementia

    Week 10

  • Client Satisfaction Questionnaire--Caregivers

    Week 10

  • Zarit Burden Interview

    Baseline, Week 10

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

    Baseline, Week 10

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

    Baseline, Week 10

  • +8 more secondary outcomes

Other Outcomes (5)

  • Percentage Adherence to Independent Practice--Persons With Dementia

    Week 10

  • Percentage Adherence to Independent Practice--Caregivers

    Week 10

  • Qualitative Questions

    Baseline, Week 10

  • +2 more other outcomes

Study Arms (1)

Yoga for Caregivers and Persons With Dementia

EXPERIMENTAL

Persons With Dementia and their caregivers will participate in up to 20 group yoga classes.

Behavioral: Gentle Yoga

Interventions

Gentle YogaBEHAVIORAL

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.

Yoga for Caregivers and Persons With Dementia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Gretchen Brenes, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2021

First Posted

November 2, 2021

Study Start

May 2, 2022

Primary Completion

August 4, 2022

Study Completion

August 4, 2022

Last Updated

February 13, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations