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Yoga for Family Caregivers of Alzheimers Disease Patient

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: NCT02563483
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):
JGalduroz, Federal University of São Paulo

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.

Condition or disease Intervention/treatment Phase
Stress Anxiety Compassion Behavioral: yoga and compassion meditation program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : November 2009


Arm Intervention/treatment
Experimental: Yoga and compassion meditation program
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.
Behavioral: yoga and compassion meditation program
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.

No Intervention: control
this group was a non treatment group.



Primary Outcome Measures :
  1. change in cortisol [ Time Frame: baseline, 8 weeks ]
    Saliva samples were collected for analysis of cortisol


Secondary Outcome Measures :
  1. change in stress [ Time Frame: baseline, 8 weeks ]
    Lipp Stress Inventory

  2. change in depression [ Time Frame: baseline, 8 weeks ]
    Beck Depression Inventory

  3. change in anxiety [ Time Frame: baseline, 8 weeks ]
    Beck Anxiety Inventory

  4. change in quality of life [ Time Frame: baseline, 8 weeks ]
    WHOQOL-bref (World Health Organization Quality of Life Questionnaire with 26 questions)

  5. change in vitality [ Time Frame: baseline, 8 weeks ]
    Subjective Vitality Scales

  6. change in attention [ Time Frame: baseline, 8 weeks ]
    Mindfulness Attention Awareness Scale

  7. change in self-compassion [ Time Frame: baseline, 8 weeks ]
    Self-Compassion Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Additional Information:
Publications:
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Responsible Party: JGalduroz, MD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02563483    
Other Study ID Numbers: yoga caregivers
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2015
Keywords provided by JGalduroz, Federal University of São Paulo:
caregivers
anxiety
depression
yoga
meditation
stress
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders