Clinical trial NCT01204021: Managing Stress and Social Ties for Health Aging
Official title: Managing Stress and Social Ties for Health Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: Stress
loneliness
social isolation
autonomic activity
inflammation
Perceived social isolation
Chronic stress
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2010-09-17
Enrollment: 26
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: There has been a dramatic rise from 46% to 59% in the percentage of households with only 1-2 people from 1970 to 2000. A 40% increase in the number of people living alone is projected for 2010. Social isolation is consistently one of the strongest predictors mortality in older adults. Recent research is demonstrating that stress plays an important role linking social isolation with poor health. Socially isolated older adults are more likely to feel chronically stressed and overwhelmed with everyday life demands. Furthermore, isolated adults respond to stress differently, both psychologically and physiologically. Socially isolated and lonely older adults show long-term elevations in "inflammatory cytokines", which are signaling molecules related by immune cells. These Inflammatory cytokines play a role in a number of age-related diseases including cardiovascular disease, type-2 diabetes and arthritis. Novel, readily useable interventions aimed at decreasing isolation and "re-calibrating" stress responses might be helpful to older adults.

Tai Chi is an ancient Chinese form of calisthenics that promotes relaxation and decreases feelings of stress and as such, it may be a useful intervention for socially isolated, stressed older adults. However, its effects on stress responses are unknown. Tai Chi Chih (TCC) is a simplified, manualized, readily exportable form of Tai Chi particularly well-suited for older adults. This proposed study will test the effects of a TCC intervention with socially isolated older adults on loneliness, stress and health outcomes, including inflammatory assessment. Tai Chi-naïve participants who perceive themselves as socially isolated, as measured by the UCLA Loneliness Scale will be randomized to receive either Tai Chi or education control for a 12-week period. Subjects will undergo pre- and post-intervention stress assessment, including exposure to a psychological stress task, to assess whether Tai Chi affects how subjects physiologically and psychologically respond to stress.


Eligibility criteria: Inclusion Criteria:

* Adults \> 60 years old
* Have not done Tai Chi before
* Live in Los Angeles area
* Socially isolated
* Women must be post menopausal

Exclusion Criteria:

* Any physical debility that limits Tai Chi performance;
* Cognitive impairment (\< 23 on the Mini-Mental State Exam);
* Current or recent history of smoking
* Immune suppression resulting from neoplastic disease
* Corticosteroid use or other therapy
* Significant underlying illness that would interfere or prevent completion of the study
* Acute conditions (e.g. viral infection w/in 2 weeks) that might confound interpretation of inflammatory data
* Current or recent (within 1 month) use of illicit drugs.

Primary outcomes:
measure: Perceived Stress
timeFrame: 4-8 months
Secondary outcomes:
measure: Autonomic Activity and inflammatory signalling
timeFrame: 4-8 months
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Los Angeles
name: Sarosh J Motivala, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Black DS, Irwin MR, Olmstead R, Ji E, Crabb Breen E, Motivala SJ. Tai chi meditation effects on nuclear factor-kappaB signaling in lonely older adults: a randomized controlled trial. Psychother Psychosom. 2014;83(5):315-7. doi: 10.1159/000359956. Epub 2014 Aug 6. No abstract available.