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Yoga for Family Caregivers of Alzheimers Disease Patient

Primary Purpose

Stress, Anxiety, Compassion

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
yoga and compassion meditation program
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress focused on measuring caregivers, anxiety, depression, yoga, meditation, stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • be a family caregiver of Alzheimer disease patient
  • age over 18 years
  • completed at least the primary education level
  • at least at the phase of stress resistance according to Lipp's Inventory of Stress Symptoms for adults

Exclusion Criteria:

  • patient with asthma or chronic obstructive pulmonary disease (COPD)
  • alcohol use (more than 5 drinks per week) or use of drugs-of-abuse;
  • suffer from Cushing's syndrome
  • under treatment with topical, nasal or any form of steroids within the last 30 days
  • practice yoga, meditation or similar techniques

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Yoga and compassion meditation program

    control

    Arm Description

    The duration of this group was 8 weeks. The program included sessions 3 times per week, with each session lasting 1 hour and 15 minutes. The volunteers performed yoga classes composed of "asana" (poses), "pranayama" (breathing exercise) and meditation.

    this group was a non treatment group.

    Outcomes

    Primary Outcome Measures

    change in cortisol
    Saliva samples were collected for analysis of cortisol

    Secondary Outcome Measures

    change in stress
    Lipp Stress Inventory
    change in depression
    Beck Depression Inventory
    change in anxiety
    Beck Anxiety Inventory
    change in quality of life
    WHOQOL-bref (World Health Organization Quality of Life Questionnaire with 26 questions)
    change in vitality
    Subjective Vitality Scales
    change in attention
    Mindfulness Attention Awareness Scale
    change in self-compassion
    Self-Compassion Scale

    Full Information

    First Posted
    September 28, 2015
    Last Updated
    September 29, 2015
    Sponsor
    Federal University of São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02563483
    Brief Title
    Yoga for Family Caregivers of Alzheimers Disease Patient
    Official Title
    A Yoga and Compassion Meditation Program Improve Quality of Life and Self-compassion in Family Caregivers of Alzheimer's Disease Patients: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2007 (undefined)
    Primary Completion Date
    February 2008 (Actual)
    Study Completion Date
    November 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of São Paulo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study evaluates the effects of the practice of yoga in combination with compassion meditation on the quality of life, attention, vitality and self-compassion of family caregivers of patients with Alzheimer's disease.
    Detailed Description
    Alzheimer's disease is a progressive brain disorder that involves the loss of reasoning, memory, language and the ability to live independently. Thus, patients who suffer from this disease often require care from another person and must adapt to ensure their health, functional capacity and safety. Caregivers have a poor quality of life due to the physical and psychological burden of caregiving. Such physical, psychological, social and financial burden can increase the risk of death. Within this scenario, techniques such as yoga and meditation have emerged as low-cost interventions that offer little or no risk to the practitioners. Yoga seeks to develop health and attention through physical postures, breathing exercises and formal meditative practices.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stress, Anxiety, Compassion
    Keywords
    caregivers, anxiety, depression, yoga, meditation, stress

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Yoga and compassion meditation program
    Arm Type
    Experimental
    Arm Description
    The duration of this group was 8 weeks. The program included sessions 3 times per week, with each session lasting 1 hour and 15 minutes. The volunteers performed yoga classes composed of "asana" (poses), "pranayama" (breathing exercise) and meditation.
    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    this group was a non treatment group.
    Intervention Type
    Behavioral
    Intervention Name(s)
    yoga and compassion meditation program
    Intervention Description
    25 min of physical exercise, holding each pose (stretching exercise) for an average of 1 min and 30 s; 25 min of breathing exercises and 25 min of meditation.
    Primary Outcome Measure Information:
    Title
    change in cortisol
    Description
    Saliva samples were collected for analysis of cortisol
    Time Frame
    baseline, 8 weeks
    Secondary Outcome Measure Information:
    Title
    change in stress
    Description
    Lipp Stress Inventory
    Time Frame
    baseline, 8 weeks
    Title
    change in depression
    Description
    Beck Depression Inventory
    Time Frame
    baseline, 8 weeks
    Title
    change in anxiety
    Description
    Beck Anxiety Inventory
    Time Frame
    baseline, 8 weeks
    Title
    change in quality of life
    Description
    WHOQOL-bref (World Health Organization Quality of Life Questionnaire with 26 questions)
    Time Frame
    baseline, 8 weeks
    Title
    change in vitality
    Description
    Subjective Vitality Scales
    Time Frame
    baseline, 8 weeks
    Title
    change in attention
    Description
    Mindfulness Attention Awareness Scale
    Time Frame
    baseline, 8 weeks
    Title
    change in self-compassion
    Description
    Self-Compassion Scale
    Time Frame
    baseline, 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: be a family caregiver of Alzheimer disease patient age over 18 years completed at least the primary education level at least at the phase of stress resistance according to Lipp's Inventory of Stress Symptoms for adults Exclusion Criteria: patient with asthma or chronic obstructive pulmonary disease (COPD) alcohol use (more than 5 drinks per week) or use of drugs-of-abuse; suffer from Cushing's syndrome under treatment with topical, nasal or any form of steroids within the last 30 days practice yoga, meditation or similar techniques

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23690846
    Citation
    Danucalov MA, Kozasa EH, Ribas KT, Galduroz JC, Garcia MC, Verreschi IT, Oliveira KC, Romani de Oliveira L, Leite JR. A yoga and compassion meditation program reduces stress in familial caregivers of Alzheimer's disease patients. Evid Based Complement Alternat Med. 2013;2013:513149. doi: 10.1155/2013/513149. Epub 2013 Apr 18.
    Results Reference
    background
    Links:
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/23690846
    Description
    A yoga and compassion meditation program reduces stress in familial caregivers of Alzheimer's disease patients

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