Short-bout Handgrip Exercise for Smoking Cessation (SHESC)
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|ClinicalTrials.gov Identifier: NCT02844296|
Recruitment Status : Recruiting
First Posted : July 26, 2016
Last Update Posted : May 9, 2017
Smoking is highly addictive and quitting is difficult. Relapse is common because of withdrawal symptoms such as craving, headache, mood change and irritation. In addition to pharmacotherapy, exercise can acutely reduce craving, withdrawal symptoms and negative affect in regular smokers. Exercise effectively reduces negative affect and attentional bias towards smoking, and hence might relieve craving.Instead of long duration (30+ minutes) exercise, short-bout exercise is more easily adhered to in daily living and achieves similar health gain as long-bout exercise.Handgrip, which enhances training of hand-griping strength, is a common short-bout exercise tool used for lowering blood and arterial pressure.Therefore, this exercise tool might also raise smokers' interest to initiate this simple and effective exercise for quit attempt.
This RCT study was proposed by using short-bout exercise (intervention) and healthy diet (control ) for smoking cessation, targeting adult clients who enrolled in smoking cessation service of ICSC, smoke 10 cigarettes or more a day when they initially receive the treatment from ICSC, can access to Internet by using smart phone and interested in participating in an exercise/diet program for smoking cessation. All the participants will be randomized the subjects to one of the RCT groups by using sequentially numbered, opaque sealed envelope method. Participants from both groups will be helped to install a phone application (App) in their smartphone which can send reminders of doing exercise or healthy diet. Also, the participants will enter their smoking and craving data by the App by answering the automatic pooped daily questionnaire. Telephone follow-up will be conducted at 2,6 and 12 months.
|Condition or disease||Intervention/treatment|
|Smoking Cessation||Behavioral: Video about exercise Behavioral: App about exercise Behavioral: Leaflet about exercise Behavioral: Video about diet Behavioral: App about diet Behavioral: Leaflet about diet|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy of a Short-bout Handgrip Exercise Intervention for Smoking Cessation: a Pilot Randomized Controlled Trial|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: exercise group
A free handgrip (strength 15 kg) will be given to the subject and some short-bout exercise will be introduced to the subjects for reliving the cravings for smoking through a short video. After the video, the counselor will install a smartphone application which is about exercise in the subject's mobile phone to set up exercise reminder schedule for 4 weeks. 20-30 reminders on exercise and quitting tips via the App for 4 weeks. Subjects will be requested o record a daily diary on smoking.
A leaflet with exercise instruction and motivation messages based on the Health Action Process Approach (HAPA) will be given to the participant. 2-month, 6 -month and 12-month telephone interview will be conducted. Biochemical validation will be conducted at 6-month follow up. And hand grip strength will be measured the next time when the participant comes back to CISI.
Behavioral: Video about exercise
Video about short-bout exercise will be played for the participants.Behavioral: App about exercise
A smartphone App about exercise will be installed in participants' mobile phone.Behavioral: Leaflet about exercise
A leaflet about exercise will be provided for the participants.
Experimental: diet group
Subjects will view a short video on healthy diet only. After the video, the counselor will also install another smartphone application which is about healthy diet in the subject's mobile phone to set up healthy die reminder schedule for 4 weeks.
A leaflet on healthy diet will be given to the subjects, and 20-30 reminders on healthy diet and quitting tips via the App for 4 weeks.2-,6- and 12-month telephone interview will be conducted. Biochemical validation will be conducted at 6-month follow up. And hand grip strength will be measured the next time when the participant comes back to CISI.
Behavioral: Video about diet
Video about healthy diet will be played for the participants.Behavioral: App about diet
A smartphone App about healthy diet will be installed in participants' mobile phone.Behavioral: Leaflet about diet
A leaflet about healthy diet will be provided for the participants.
- 4-week self-reported tobacco abstinence at 6-month follow-up [ Time Frame: 6 months ]4-week self-reported tobacco abstinence at 6-month follow-up
- Self-reported 7-day point prevalence abstinence [ Time Frame: 2 and 6 months ]The subjects will be contacted via telephone at 2-,6-month to access: self-reported 7-day prevalence abstinence.
- Grip strength measurement [ Time Frame: baseline, 1 month and 6 months ]Grip strength (kg) at baseline, 1-month and 6-month follow-up
- Minnesota Nicotine Withdrawal Scale [ Time Frame: baseline, 2 and 6 months ]
Validated Minnesota Nicotine Withdrawal Scale, which is a 5-pointed scale included 9 questions. Measured at 2-, 6- and 12-month follow-up
Each point has a corresponding score, the scores will be added together as an overall score to predict the severity of the subject's withdrawal symptoms.
The higher the score is, the severer the subject's withdrawal symptoms is.
- International Physical Activity Questionnaire [ Time Frame: baseline, 2 and 6 months ]
The time and days of doing vigorous, moderate exercise and walking will be asked and recorded. All these exercise will be added together (Total MET-minutes/week at work = Walk (METs*min*days) + Mod (METs*min*days) + Vig(METs*min*days)).
The higher the number the subject get, the more exercise the subject have had in the past 7 days.
- Perceived effectiveness of using handgrip/healthy diet to relieve cravings for smoking [ Time Frame: 2 months ]
The subjects will be contacted via telephone at 2-month to access their perceived effectiveness of using handgrip/healthy diet to relieve cravings, which is a 5-pointed scale included 7 questions.
Each point has a corresponding score, the scores will be added together as an overall score to predict the severity of the subject's perceived effectiveness of using handgrip/healthy diet to relieve cravings for smoking.
The higher the score is, the more the subject's perceived handgrip/healthy diet is effective for relieving their smoking cravings.
- The Smoking Self-Efficacy Questionnaire [ Time Frame: 12 months ]
The subjects will be contacted via telephone at 12-month to access the subject's self-efficacy of not smoking by using validated Smoking Self-Efficacy Questionnaire, 5-pointed scale included 13 questions.
Each point has a corresponding score, the scores will be added together as an overall score to predict the subject's self-efficacy of not smoking.
The higher the score is, the stronger the the subject's feel confident to not smoke.
- Biochemical validated abstinence [ Time Frame: 6 months ]Exhaled carbon monoxide will be measured with a smokerlyzer at 6 month. Participants with exhaled CO below 4ppm are defined as validated quitters.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844296
|Contact: Tai Hing Lam, MDemail@example.com|
|Integrated Centre on Smoking Cessation, Tung Wah Group of Hospitals||Recruiting|
|Hong Kong, Hong Kong|
|Contact: Helen Chan, MPH +852 28271068 firstname.lastname@example.org|
|Principal Investigator:||Tai Hing Lam, MD||The University of Hong Kong|