The Effect of Cigarette Smoking / Smoking Cessation on Skeletal Muscle Mass, Strength and Functional Capabilities
1 other identifier
observational
81
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 19, 2014
CompletedFirst Posted
Study publicly available on registry
May 1, 2014
CompletedMay 1, 2014
April 1, 2014
1.7 years
March 19, 2014
April 29, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Parameters of body composition and muscle function in continued smokers versus quitters
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
Study Arms (1)
Heavy smokers
Assessment of body composition and muscle function
Interventions
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
Eligibility Criteria
Subjects were recruited from support groups of smoking cessation conducted at "Clalit Health Services" at Haifa and Western Galilee district.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rambam Health Care Campus
Haifa, Israel
Related Publications (1)
Rom O, Reznick AZ, Keidar Z, Karkabi K, Aizenbud D. Smoking cessation-related weight gain--beneficial effects on muscle mass, strength and bone health. Addiction. 2015 Feb;110(2):326-35. doi: 10.1111/add.12761. Epub 2014 Nov 12.
PMID: 25312589DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dror Aizenbud, Professor
Rambam Health Care Campus
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2014
First Posted
May 1, 2014
Study Start
June 1, 2012
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
May 1, 2014
Record last verified: 2014-04