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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

Tracking Information
First Submitted Date  ICMJE September 28, 2015
First Posted Date  ICMJE September 30, 2015
Last Update Posted Date September 30, 2015
Study Start Date  ICMJE September 2007
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2015)
change in cortisol [ Time Frame: baseline, 8 weeks ]
Saliva samples were collected for analysis of cortisol
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2015)
  • change in stress [ Time Frame: baseline, 8 weeks ]
    Lipp Stress Inventory
  • change in depression [ Time Frame: baseline, 8 weeks ]
    Beck Depression Inventory
  • change in anxiety [ Time Frame: baseline, 8 weeks ]
    Beck Anxiety Inventory
  • change in quality of life [ Time Frame: baseline, 8 weeks ]
    WHOQOL-bref (World Health Organization Quality of Life Questionnaire with 26 questions)
  • change in vitality [ Time Frame: baseline, 8 weeks ]
    Subjective Vitality Scales
  • change in attention [ Time Frame: baseline, 8 weeks ]
    Mindfulness Attention Awareness Scale
  • change in self-compassion [ Time Frame: baseline, 8 weeks ]
    Self-Compassion Scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Yoga for Family Caregivers of Alzheimers Disease Patient
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stress
  • Anxiety
  • Compassion
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: yoga and compassion meditation program
  • No Intervention: control
    this group was a non treatment group.
Publications * Danucalov MA, Kozasa EH, Ribas KT, Galduróz 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2015)
46
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02563483
Other Study ID Numbers  ICMJE yoga caregivers
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party JGalduroz, Federal University of São Paulo
Study Sponsor  ICMJE Federal University of São Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Federal University of São Paulo
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP