NCT02128048

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
Last Updated

May 1, 2014

Status Verified

April 1, 2014

Enrollment Period

1.7 years

First QC Date

March 19, 2014

Last Update Submit

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

Device: 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

Heavy smokers

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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.

MeSH Terms

Conditions

Smoking CessationGlucocorticoid Receptor DeficiencyMuscle Weakness

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Dror Aizenbud, Professor

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

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

Locations