- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02563483
Yoga for Family Caregivers of Alzheimers Disease Patient
September 29, 2015 updated by: JGalduroz, Federal University of São Paulo
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in cortisol
Time Frame: baseline, 8 weeks
|
Saliva samples were collected for analysis of cortisol
|
baseline, 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in stress
Time Frame: baseline, 8 weeks
|
Lipp Stress Inventory
|
baseline, 8 weeks
|
|
change in depression
Time Frame: baseline, 8 weeks
|
Beck Depression Inventory
|
baseline, 8 weeks
|
|
change in anxiety
Time Frame: baseline, 8 weeks
|
Beck Anxiety Inventory
|
baseline, 8 weeks
|
|
change in quality of life
Time Frame: baseline, 8 weeks
|
WHOQOL-bref (World Health Organization Quality of Life Questionnaire with 26 questions)
|
baseline, 8 weeks
|
|
change in vitality
Time Frame: baseline, 8 weeks
|
Subjective Vitality Scales
|
baseline, 8 weeks
|
|
change in attention
Time Frame: baseline, 8 weeks
|
Mindfulness Attention Awareness Scale
|
baseline, 8 weeks
|
|
change in self-compassion
Time Frame: baseline, 8 weeks
|
Self-Compassion Scale
|
baseline, 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
February 1, 2008
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
September 28, 2015
First Submitted That Met QC Criteria
September 29, 2015
First Posted (Estimate)
September 30, 2015
Study Record Updates
Last Update Posted (Estimate)
September 30, 2015
Last Update Submitted That Met QC Criteria
September 29, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- yoga caregivers
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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