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CompletedNCT01204021Updated Nov 18, 2016

Managing Stress and Social Ties for Health Aging

An interventional study of Tai Chi Chih and Stress Education Control in Stress, sponsored by University of California, Los Angeles. Completed. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-18.

Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Stress

Keywords

  • Stress
  • loneliness
  • social isolation
  • autonomic activity
  • inflammation
  • Perceived social isolation
  • Chronic stress
03

In context

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Tai Chi Chih

    12 weeks of physical exercise in the form of Tai Chi Chih

    Behavioral: Tai Chi Chih

  • Active comparator
    Stress Education Control

    Stress management education

    Behavioral: Stress Education Control

Interventions

  • BehavioralTai Chi Chih

    12 weeks of weekly classes of Tai Chi Chih

    Also known as: Tai Chi, exercise, relaxation

  • BehavioralStress Education Control

    Weekly meetings, for 2 hours for 12 weeks discussing issues related to stress education.

    Also known as: stress education, stress information

06

What researchers measure

Primary outcomes

  1. Perceived Stress

    Time frame: 4-8 months

Secondary outcomes

  1. Autonomic Activity and inflammatory signalling

    Time frame: 4-8 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 25116908 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01204021
Lead sponsor
University of California, Los Angeles
Responsible party
Sponsor
First posted
Sep 17, 2010
Start date
May 2008
Primary completion
Aug 2010
Completion
Aug 2010
Last update
Nov 18, 2016

Study contacts

Sarosh J Motivala, Ph.D.
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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