Managing Stress and Social Ties for Health Aging

Stress Clinical Trial

Official title:

Managing Stress and Social Ties for Health Aging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01204021
• Other study ID #: AG028748-01-SST
• Status: Completed
• Phase: N/A
• First received: January 25, 2010
• Last updated: November 16, 2016
• Start date: May 2008
• Est. completion date: August 2010

Study information

• Verified date: November 2016
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Stress

Intervention

Behavioral:
• Tai Chi Chih
12 weeks of weekly classes of Tai Chi Chih
• Stress Education Control
Weekly meetings, for 2 hours for 12 weeks discussing issues related to stress education.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

References & Publications (1)

Black DS, Irwin MR, Olmstead R, Ji E, Crabb Breen E, Motivala SJ. Tai chi meditation effects on nuclear factor-?B signaling in lonely older adults: a randomized controlled trial. Psychother Psychosom. 2014;83(5):315-7. doi: 10.1159/000359956. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived Stress		4-8 months	No
Secondary	Autonomic Activity and inflammatory signalling		4-8 months	No