- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01204021
Managing Stress and Social Ties for Health Aging
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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Tai Chi Chih
12 weeks of physical exercise in the form of Tai Chi Chih
|
12 weeks of weekly classes of Tai Chi Chih
다른 이름들:
|
활성 비교기: Stress Education Control
Stress management education
|
Weekly meetings, for 2 hours for 12 weeks discussing issues related to stress education.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Perceived Stress
기간: 4-8 months
|
4-8 months
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Autonomic Activity and inflammatory signalling
기간: 4-8 months
|
4-8 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Sarosh J Motivala, Ph.D., University of California, Los Angeles
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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