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
About this trial
This is an interventional treatment trial for Stress focused on measuring caregivers, anxiety, depression, yoga, meditation, stress
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
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
NCT ID
NCT02563483
First Posted
September 28, 2015
Last Updated
September 29, 2015
Sponsor
Federal University of São Paulo
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
Learn more about this trial
Yoga for Family Caregivers of Alzheimers Disease Patient
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