Determining the effects of exercise after smoking cessation therapy completion on continuous abstinence from smoking: A study protocol
Authors: Ozaki Yuka , Komiyama Maki , Ueshima Kenji , Iso Hiroyasu , Sakata Satoko , Morino Ayumi , Takahara Mitsuyoshi , Noguchi Satoshi , Kuwabara Yoshihiro , Takahashi Yuko , Hasegawa Koji 
Published: January 2019

Abstract
Background: Over the past few years, the rate of success for smoking cessation has improved markedly owing to the widespread availability of drug therapy; however, the quit rate 1 year after the beginning of therapy remains low at approximately 50%. Previous studies have demonstrated that exercise can relieve mental stress during continuous abstinence from smoking and curb the resumption of smoking. Nonetheless, very few studies have examined the effects of exercise therapy combined with continuous abstinence from smoking; those studies involved only a handful of patients. Thus, this study will examine continuous abstinence from smoking coupled with instructions on specific forms of exercise in individuals who are attempting to quit smoking but do not exercise. We aimed to determine the effects of implementing an intervention in the form of exercise instruction after smoking cessation therapy completion on continuous abstinence from smoking. If this study finds that exercise instruction increases the continuous abstinence rate, widespread implementation of the intervention is expected to reduce public smoking rate, promote health, reduce medical expenses, and greatly benefit the public.
Methods: We will enroll patients visiting a smoking cessation clinic (over a 3-month period) who have abstained from smoking in the second month after their initial visit as potential subjects and patients aged 20–75 years who do not exercise and who consent to participation in this study as subjects. We aim to enroll 300 patients. Subjects will be randomly assigned to one of the following two groups: an intervention group actively given exercise instruction in addition to the standard instruction and a control group given the standard instruction. The status of the two groups will be assessed after 9 months. The intervention group will receive instruction on exercises that can be incorporated into their daily lives. Additionally, members of this group will be lent a pedometer and encouraged to record their daily step count, level of activity, and weight during follow-up. The control group will be followed during the standard smoking cessation support program. The primary endpoint will be the continuous abstinence rate, and secondary endpoints will be weight, blood pressure, exhaled carbon monoxide concentration, psychological state, and blood test results. These indices will be compared between the intervention and control groups; the study will be conducted over a 9-month period.
Discussion: By examining the effects of exercise instruction after 12-weeks smoking cessation therapy completion (covered by the National Health Insurance), this study will yield quality information for the development of protocols to improve the continuous abstinence rate and inhibit weight gain after smoking cessation therapy.
Trial registration: The study is registered at UMIN Clinical Trials Registry (UMIN000014615). Registered on 1st October, 2014.
Keywords: Smoking cessation, exercise, weight gain, obesity