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Chair Yoga for Stress in Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04162964
Recruitment Status : Suspended (COVID-19)
First Posted : November 14, 2019
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Soham Rej MD, MSc, Lady Davis Institute

Brief Summary:

Dementia is widely prevalent and results in high direct and indirect health costs. Dementia is associated with stress, anxiety, and depression in both patients and caregivers, and caregiver burden is extremely common. Treatment protocols for patients and caregivers are unclear and insufficient; drug treatments to manage behavioural and psychological symptoms of dementia can yield serious negative side effects, and caregivers may not have access to one-on-one psychotherapy due to high costs and long wait times. Yoga is an ancient Indian mind-body practice that uses physical postures, breathing exercises, and meditation. Yoga may be a viable therapeutic modality to address the psychological challenges associated with dementia in patients and caregivers, as it has been shown to decrease stress and improve anxiety and depressive symptoms in various populations. Recent research has suggested that patients with dementia and their caregivers may also experience positive effects on their mental health from practicing yoga. Furthermore, when yoga is taught in a gentle and mindful manner, it is generally not associated with any negative side effects. While there is preliminary data on dyadic exercise interventions for dementia patients and their caregivers, to date no research has examined the effectiveness of a dyadic yoga intervention on stress, anxiety, and depression.

The investigators propose an 8-week study of a dyadic chair yoga program for patients with mild to moderate dementia and their caregivers (n = 30-40 participants). Our primary outcome of interest is changes in perceived stress, while secondary outcomes include changes in symptoms of depression and anxiety. The investigators will also look at the effects of the chair yoga program on caregiver burden, quality of interactions, well-being, mindfulness, and self-compassion. All outcomes will be assessed before the program starts and upon its termination. Participants will attend a 1-hour weekly group yoga class (4-10 participants per group) with their dyad for 8-weeks, and will also be given a video recording of a yoga class to practice together at home as often as possible. The investigators hypothesize that after the 8 week yoga program, patients and caregivers will report lower stress, as well as reduced symptoms of anxiety and depression. Results will be available mid-2020.


Condition or disease Intervention/treatment Phase
Dementia Stress Behavioral: Chair Yoga Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of a Dyadic Chair Yoga Intervention for Reducing Stress in Patients With Dementia and Their Caregivers
Actual Study Start Date : January 27, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: Chair Yoga
    8-week dyadic chair yoga program for one hour per week. Chair yoga is an effective way to offer modified yoga postures and relaxation techniques to individuals with limited mobility and/or advanced age for whom mat-based classes may not be accessible. The weekly yoga classes will be lead by a certified instructor and will include 4-10 participants (or 2-5 patient-caregiver dyads).


Primary Outcome Measures :
  1. Changes in perceived stress scores as measured by the Perceived Stress Scale (PSS) [ Time Frame: Baseline, 8-weeks ]

    Using an 8-week single arm pilot trial, assess the effects of chair yoga on perceived stress in patients and caregivers, using the PSS.

    Scores on the PSS can range from 0-40, with higher scores indicating higher perceived stress

    Hypothesis: Following participation in an 8-week gentle chair yoga program, patients with dementia and their caregivers will report lower perceived stress, as measured by the Perceived Stress Scale (PSS)



Secondary Outcome Measures :
  1. Changes in depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9) [ Time Frame: Baseline, 8-weeks ]

    Using an 8-week single arm pilot trial, assess the effects of chair yoga on patient and caregiver depressive symptoms using the PHQ-9.

    Scores on the PHQ-9 can range from 0-27, with higher scores indicating more severe depression.

    Hypothesis: Patients with dementia and their caregivers will report less severe symptoms of depression, as measured by the full version of the Patient Health Questionnaire (PHQ-9), following participation in an 8-week gentle chair yoga program.


  2. Changes in symptoms of anxiety as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7) [ Time Frame: Baseline, 8-weeks ]

    Using an 8-week single arm pilot trial, assess the effects of chair yoga on symptoms of anxiety in patients and caregivers using the GAD-7.

    Scores on the GAD-7 range from 0-21, with higher scores indicating more severe anxiety.

    Hypothesis: Patients with dementia and/or their caregivers will report fewer symptoms of anxiety, as measured by the Generalized Anxiety Disorder 7-Item Scale (GAD-7), following participation in an 8-week gentle chair yoga program.



Other Outcome Measures:
  1. Changes in caregiver burden as measured by the Zarit Burden Inventory (ZBI) [ Time Frame: Baseline, 8-weeks ]

    Assess the effects of chair yoga on caregiver burden using the ZBI following 8 weeks of chair yoga.

    Scores on the ZBI can range from 0-88, with higher scores corresponding to higher levels of burden.

    Hypothesis 1: Caregivers of patients with dementia will report lower caregiver burden, as measured by the Zarit Burden Scale (ZBI), following participation in an 8-week gentle chair yoga program.

    Hypothesis 2: Lower patient scores on the PHQ-9 and GAD-7 (week 8) will be associated with decreased caregiver burden following participation in an 8-week gentle chair yoga program.


  2. Changes in relationship closeness as measured by the Whitlatch Relationship Closeness Scale [ Time Frame: Baseline, 8-weeks ]

    Assess the effects of chair yoga on levels of caregiver-rated relationship closeness using the Whitlatch Relationship Closeness Scale.

    Scores on the Whitlatch Relationship Closeness Scale range from 0-24, with higher scores indicating closer relationships.


  3. Changes in well-being as measured by the 12-Item Well-Being Questionnaire (W-BQ12) [ Time Frame: Baseline, 8-weeks ]

    Assess the effects of 8-weeks of chair yoga on patient and caregiver well-being using the W-BQ12.

    Scores on the W-BQ12 range from 0-72, with higher scores indicating a greater sense of well-being.


  4. Changes in levels of mindfulness as measured by the Five Facet Mindfulness Questionnaire (FFMQ-short form) [ Time Frame: Baseline, 8-weeks ]

    Assess the effects of 8 weeks of chair yoga on patient and caregiver levels of mindfulness using the short form of the FFMQ.

    Scores on the short-form of the Five Facet Mindfulness Scale range from 0-120, with higher scores indicating higher levels of mindfulness.


  5. Changes in levels of self-compassion as measured by the Self-Compassion Scale (SCS-short form) [ Time Frame: Baseline, 8-weeks ]

    Assess the effects of 8 weeks of chair yoga on patient and caregiver levels of self-compassion using the short form of the SCS.

    Scores on the short for of the SCS range from 0-60, with higher scores indicating higher levels of self-compassion.




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients will have mild cognitive impairment or mild to moderate dementia (MMSE score between 10-26 inclusive) OR a diagnosis from his/her clinician of mild cognitive impairment or mild to moderate dementia
  • Patient and caregiver have contact at least 3 times per week
  • Either patient and/or caregiver will have a score of at least 10 on the PSS
  • Sufficient hearing to follow verbal instructions
  • Able to sit for 45 minutes without discomfort

Exclusion Criteria:

  • Patients will not have severe dementia (MMSE score < 10 OR diagnosis from his/her clinician)
  • Caregivers will not have dementia (MMSE score < 24)
  • Acute psychotic symptoms
  • Acute suicidal ideation or intent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04162964


Locations
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Canada, Quebec
Institute of Community and Family Psychiatry
Montreal, Quebec, Canada, H3T 1E4
Douglas Mental Health University Institute
Montreal, Quebec, Canada, H4H 1R3
Sponsors and Collaborators
Lady Davis Institute
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Responsible Party: Soham Rej MD, MSc, Principal Investigator, Lady Davis Institute
ClinicalTrials.gov Identifier: NCT04162964    
Other Study ID Numbers: GeriPARTy
First Posted: November 14, 2019    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Soham Rej MD, MSc, Lady Davis Institute:
Dementia
Stress
Caregiving
Mind-body therapy
Anxiety
Depression
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders