NCT01204021

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2008

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 17, 2010

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

2.3 years

First QC Date

January 25, 2010

Last Update Submit

November 16, 2016

Conditions

Keywords

Stresslonelinesssocial isolationautonomic activityinflammationPerceived social isolationChronic stress

Outcome Measures

Primary Outcomes (1)

  • Perceived Stress

    4-8 months

Secondary Outcomes (1)

  • Autonomic Activity and inflammatory signalling

    4-8 months

Study Arms (2)

Tai Chi Chih

EXPERIMENTAL

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

Behavioral: Tai Chi Chih

Stress Education Control

ACTIVE COMPARATOR

Stress management education

Behavioral: Stress Education Control

Interventions

Tai Chi ChihBEHAVIORAL

12 weeks of weekly classes of Tai Chi Chih

Also known as: Tai Chi, exercise, relaxation
Tai Chi Chih

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

Also known as: stress education, stress information
Stress Education Control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Social IsolationInflammation

Interventions

Tai JiExercise

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy ModalitiesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Sarosh J Motivala, Ph.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2010

First Posted

September 17, 2010

Study Start

May 1, 2008

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

November 18, 2016

Record last verified: 2016-11