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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02563483
Other study ID # yoga caregivers
Secondary ID
Status Completed
Phase N/A
First received September 28, 2015
Last updated September 29, 2015
Start date September 2007
Est. completion date November 2009

Study information

Verified date September 2015
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: Ministry of Health
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date November 2009
Est. primary completion date February 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Federal University of São Paulo

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary change in cortisol Saliva samples were collected for analysis of cortisol baseline, 8 weeks No
Secondary change in stress Lipp Stress Inventory baseline, 8 weeks No
Secondary change in depression Beck Depression Inventory baseline, 8 weeks No
Secondary change in anxiety Beck Anxiety Inventory baseline, 8 weeks No
Secondary change in quality of life WHOQOL-bref (World Health Organization Quality of Life Questionnaire with 26 questions) baseline, 8 weeks No
Secondary change in vitality Subjective Vitality Scales baseline, 8 weeks No
Secondary change in attention Mindfulness Attention Awareness Scale baseline, 8 weeks No
Secondary change in self-compassion Self-Compassion Scale baseline, 8 weeks No
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