Smoking CessationNCT02128048
The Effect of Cigarette Smoking / Smoking Cessation on Skeletal Muscle Mass, Strength and Functional Capabilities
An observational study of Smoking Cessation and Body Composition, Beneficial, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Body Composition, Beneficial, Muscle Weakness
- What is being tested?
- Assessment of body composition and muscle function
- Type of treatment
- Medical device
- How many people
- 81 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2012to Feb 2014
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects were recruited from support groups of smoking cessation conducted at "Clalit Health Services" at Haifa and Western Galilee district.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Body composition and muscle function were assessed at the beginning of a smoking cessation program and again after 12 months. Changes in body composition and muscle function were compared between continued smokers and quitters.
- Being tested
- Assessment of body composition and muscle function
- Medical subject headings
- Smoking Cessation, Glucocorticoid Receptor Deficiency, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of body composition and muscle functionDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Heavy smokers | Assessment of body composition and muscle function Receives: Device: Assessment of body composition and muscle function |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startJun 2012
- Primary completionFeb 2014
- Study completionFeb 2014
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 Smoking CessationStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dror Aizenbud, Professor, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128048
- Sponsor's protocol ID
- Version 01 Dated 27-March-2012
- Status last verified
- Apr 2014
- First submitted
- 19 Mar 2014
- Last updated
- 1 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25312589
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cigarette Smoking / Smoking Cessation on Skeletal Muscle Mass, Strength and Functional Capabilities
- ClinicalTrials.gov ID
- NCT02128048
- Acronym / sponsor ID
- Version 01 Dated 27-March-2012
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 1 May 2014 (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.
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.
Detailed description
Body composition and muscle function were assessed at the beginning of a smoking cessation program and again after 12 months. Changes in body composition and muscle function were compared between continued smokers and quitters.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heavy smokers | – | Device: Assessment of body composition and muscle functionAssessment of body composition and muscle function |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects were recruited from support groups of smoking cessation conducted at "Clalit Health Services" at Haifa and Western Galilee district.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Assessment of body composition and muscle functionAssessment of body composition by DEXA and BIA Measurement of muscle function by hand-grip dynamometer and physical tests Comparison between quitters and continued smokers | Device | Heavy smokers |
Primary outcome
Parameters of body composition and muscle function in continued smokers versus quitters
Time frame: 12 months
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.
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 1 May 2014.
- Derived from this study: PubMed 25312589Rom 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.
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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.
Dror Aizenbud, Professor principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Cessation and Body Composition, Beneficial, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. 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 1 May 2014. 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 Israel. 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.
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.
What does the primary outcome measure?
Parameters of body composition and muscle function in continued smokers versus quitters (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02128048, 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 1 May 2014.