StressNCT02563483
Yoga for Family Caregivers of Alzheimers Disease Patient
A study testing yoga and compassion meditation program in people with Stress and Anxiety, run by Federal University of São Paulo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Anxiety, Compassion
- What is being tested?
- yoga and compassion meditation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Stress, Anxiety, Compassion
- Being tested
- yoga and compassion meditation program
- Keywords
- caregivers, anxiety, depression, yoga, meditation, stress
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yoga and compassion meditation programBehavioural
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 group | Role | What they receive |
|---|---|---|
| Yoga and compassion meditation program | Experimental | 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. Receives: Behavioral: yoga and compassion meditation program |
| control | No intervention | this group was a non treatment group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in cortisol
Saliva samples were collected for analysis of cortisol
Measured: baseline, 8 weeks
Secondary outcomes (7)
change in stress
Lipp Stress Inventory
Measured: baseline, 8 weeks
change in depression
Beck Depression Inventory
Measured: baseline, 8 weeks
change in anxiety
Beck Anxiety Inventory
Measured: baseline, 8 weeks
change in quality of life
WHOQOL-bref (World Health Organization Quality of Life Questionnaire with 26 questions)
Measured: baseline, 8 weeks
change in vitality
Subjective Vitality Scales
Measured: baseline, 8 weeks
change in attention
Mindfulness Attention Awareness Scale
Measured: baseline, 8 weeks
change in self-compassion
Self-Compassion Scale
Measured: baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startSep 2007
- Primary completionFeb 2008
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JGalduroz, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563483
- Sponsor's protocol ID
- yoga caregivers
- Status last verified
- Sep 2015
- First submitted
- 28 Sep 2015
- Last updated
- 30 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23690846
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02563483
- Acronym / sponsor ID
- yoga caregivers
- Conditions
- Stress, Anxiety, Compassion
- Keywords
- caregivers, anxiety, depression, yoga, meditation, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 30 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga and compassion meditation program | Experimental | Behavioral: yoga and compassion meditation programThe 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. |
| control | No intervention | –this group was a non treatment group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| yoga and compassion meditation program25 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. | Behavioural | Yoga and compassion meditation program |
Primary outcome
change in cortisol
Time frame: baseline, 8 weeks
Saliva samples were collected for analysis of cortisol
7 secondary outcomes
change in stress
Time frame: baseline, 8 weeks
change in depression
Time frame: baseline, 8 weeks
change in anxiety
Time frame: baseline, 8 weeks
change in quality of life
Time frame: baseline, 8 weeks
change in vitality
Time frame: baseline, 8 weeks
change in attention
Time frame: baseline, 8 weeks
change in self-compassion
Time frame: baseline, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2015.
- Background: PubMed 23690846Danucalov 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.
- A yoga and compassion meditation program reduces stress in familial caregivers of Alzheimer's disease patientsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing yoga and compassion meditation program in people with Stress and Anxiety, run by Federal University of São Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in cortisol (time frame: baseline, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02563483, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2015.