VaricellaPhase 2NCT00029484
Tai Chi Chih and Varicella Zoster Immunity
A Phase 2 study testing Tai chi chih in people with Varicella, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
A randomized control trial testing whether a relaxation response based intervention, Tai Chi Chih, will affect Varicella Zoster Virus (VZV) specific immunity measures of psychological adaptation and health function in the older adult. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Varicella
- What is being tested?
- Tai chi chih
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
History of Varicella or long-term resident (greater than or equal to 30 years) in the continental United States.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
San Diego, California, 90095
About this study
A randomized control trial testing whether a relaxation response based intervention, Tai Chi Chih, will affect Varicella Zoster Virus (VZV) specific immunity measures of psychological adaptation and health function in the older adult.
Read the detailed description
Both the incidence and severity of Herpes Zoster (HZ) or "Shingles" increase markedly with increasing age, is a painful condition, due to a decline in Varicella Zoster Virus (VZV) specific immunity. Considerable evidence further shows that psychological stresses salient in the older adult correlate with impairments of cellular immunity.
The investigators have observed that Varicella Zoster Immunity is always decreased in individuals with major depression. Moreover, our preliminary data indicates that the presence of depressive symptoms in older adults is associated with a decline of VZV responder cell frequency (VZV-RCF). Taken together, the untoward effects of age and depressive symptoms on VZV immunity raise the question as to whether an alternative medicine intervention might augment VZV specific immunity in the older adult. We have preliminarily shown that administration of a relaxation-response based intervention, Tai Chi Chih (TCC), results in improvements in health functioning and VZV immunity in older adults as compared to controls. TCC is a slow moving meditation comprised of twenty separate standardized movements for use in elderly populations.
This proposed controlled clinical trial aims to: 1) determine whether the practice of TCC for 16 weeks influences Varicella Zoster Virus (VZV) immunity; 2) demonstrate that TCC can produce significant changes in psychological adaptation, health behaviors, and health functioning and well-being; and 3) assess whether changes in psychological adaptation, health behaviors, and health functioning correlate with changes in VZV immunity following TCC in older adults.
We hypothesize that this behavioral intervention that prioritizes treatment of excessive physiological arousal can influence one's affective state with effects on cellular immunity. By standardization of training and practice schedules, TCC offers an important advantage over prior relaxation response based therapies. Focus on older adults at increase risk for HZ and assay of VZV specific cellular immunity has implications for understanding the impact of behavioral factors and an alternative medicine intervention on a clinically relevant endpoint and the ability of the immune system to respond to antigens of infectious pathogens.
- Conditions
- Varicella
- Being tested
- Tai chi chih
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai chi chihBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2002 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VaricellaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029484
- Sponsor's protocol ID
- R21AT000255-01
- Status last verified
- Jul 2006
- First submitted
- 11 Jan 2002
- Last updated
- 18 Aug 2006
- Results posted
- No
Publications
Irwin MR, Pike JL, Cole JC, Oxman MN. Effects of a behavioral intervention, Tai Chi Chih, on varicella-zoster virus specific immunity and health functioning in older adults. Psychosom Med. 2003 Sep-Oct;65(5):824-30. doi: 10.1097/01.psy.0000088591.86103.8f.
PubMed 14508027
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi Chih and Varicella Zoster Immunity
- ClinicalTrials.gov ID
- NCT00029484
- Acronym / sponsor ID
- R21AT000255-01
- Conditions
- Varicella
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- First posted
- 15 Jan 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized control trial testing whether a relaxation response based intervention, Tai Chi Chih, will affect Varicella Zoster Virus (VZV) specific immunity measures of psychological adaptation and health function in the older adult.
Detailed description
Both the incidence and severity of Herpes Zoster (HZ) or "Shingles" increase markedly with increasing age, is a painful condition, due to a decline in Varicella Zoster Virus (VZV) specific immunity. Considerable evidence further shows that psychological stresses salient in the older adult correlate with impairments of cellular immunity.
The investigators have observed that Varicella Zoster Immunity is always decreased in individuals with major depression. Moreover, our preliminary data indicates that the presence of depressive symptoms in older adults is associated with a decline of VZV responder cell frequency (VZV-RCF). Taken together, the untoward effects of age and depressive symptoms on VZV immunity raise the question as to whether an alternative medicine intervention might augment VZV specific immunity in the older adult. We have preliminarily shown that administration of a relaxation-response based intervention, Tai Chi Chih (TCC), results in improvements in health functioning and VZV immunity in older adults as compared to controls. TCC is a slow moving meditation comprised of twenty separate standardized movements for use in elderly populations.
This proposed controlled clinical trial aims to: 1) determine whether the practice of TCC for 16 weeks influences Varicella Zoster Virus (VZV) immunity; 2) demonstrate that TCC can produce significant changes in psychological adaptation, health behaviors, and health functioning and well-being; and 3) assess whether changes in psychological adaptation, health behaviors, and health functioning correlate with changes in VZV immunity following TCC in older adults.
We hypothesize that this behavioral intervention that prioritizes treatment of excessive physiological arousal can influence one's affective state with effects on cellular immunity. By standardization of training and practice schedules, TCC offers an important advantage over prior relaxation response based therapies. Focus on older adults at increase risk for HZ and assay of VZV specific cellular immunity has implications for understanding the impact of behavioral factors and an alternative medicine intervention on a clinically relevant endpoint and the ability of the immune system to respond to antigens of infectious pathogens.
Study design
- Allocation
- Randomised
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai chi chih | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2006.
- Background: PubMed 14508027Irwin MR, Pike JL, Cole JC, Oxman MN. Effects of a behavioral intervention, Tai Chi Chih, on varicella-zoster virus specific immunity and health functioning in older adults. Psychosom Med. 2003 Sep-Oct;65(5):824-30. doi: 10.1097/01.psy.0000088591.86103.8f.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tai chi chih in people with Varicella, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00029484, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2006.