- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02128048
The Effect of Cigarette Smoking / Smoking Cessation on Skeletal Muscle Mass, Strength and Functional Capabilities
Tobacco smoke is probably the single most significant source of toxic chemicals that humans are exposed to. Smoking is associated with a variety of pathological conditions such as cardiovascular and pulmonary diseases. In addition to the known harmful effects of cigarette smoking, several epidemiological studies identified tobacco use as a risk factor for sarcopenia, the loss of skeletal muscle mass and strength with advancing age. Previous studies examined skeletal muscles of smokers in comparison with muscles of non-smokers and found structural and metabolic damage in muscles of smokers.
Quitting of smoking is known to be associated with weight gain. A previous study examined the effects of smoking cessation on body composition of post-menopausal women using dual-energy x-ray absorptiometry (DEXA). It was found that women who successfully quit smoking for a period of 16 months have significantly increased their body weight, fat mass, muscle mass and functional muscle mass in comparison with non-quitters women. For the first time, it was shown that smoking cessation is associated with an increase of functional muscle mass. Yet, the effects of quitting of smoking on muscle mass and muscle functional capabilities of younger subjects remain unclear. Therefore, we aim to investigate the effects of smoking cessation on muscle mass, muscle function and strength in heavy smoker's subjects. Our findings may shed light on the beneficial effects of smoking cessation regarding the status and function of skeletal muscle in heavy smokers and as a possible strategy to prevent or delay the progression of sarcopenia.
Research hypothesis: Smoking cessation among adult heavy smokers will lead to increase in skeletal muscle mass and improvement of muscle function and strength compared with continued smokers.
연구 개요
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Haifa, 이스라엘
- Rambam Health Care Campus
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Healthy men and women between the ages of 18-65
- Heavy smokers (smoking more than 15 cigarettes per day)
- Taking part in smoking cessation support group at "Clalit Health Services", Haifa and Western Galilee district
Exclusion Criteria:
- Medical conditions affecting skeletal muscle metabolism or function.
- Use of corticosteroids or any other medication or nutritional supplement affecting skeletal muscle
- Consuming more than two alcoholic drinks per day
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Heavy smokers
Assessment of body composition and muscle function
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Assessment of body composition by DEXA and BIA Measurement of muscle function by hand-grip dynamometer and physical tests Comparison between quitters and continued smokers
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Parameters of body composition and muscle function in continued smokers versus quitters
기간: 12 months
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Parameters of body composition including fat mass, muscle mass, bone mineral content and density measured by DEXA and bioelectrical impedance analysis (BIA). Muscle function measured by hand-grip dynamometer and physical tests. |
12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Dror Aizenbud, Professor, Rambam Health Care Campus
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. .