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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Grip strength measurement [ Time Frame: baseline, 1 month and 6 months ]
    Grip strength (kg) at baseline, 1-month and 6-month follow-up

  3. 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.


  4. 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.


  5. 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.


  6. 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.


  7. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Newly- or re-enrolled in the smoking cessation service of ICSC within their first two times of visit (which means existing clients who did not enrolled the study in their first or second time of visiting the centre are not eligible, unless they finished the previous treatment and re-enrolled.)
  • Consume 10 or more cigarettes when initially receive the service from ICSC
  • Aged 18 years or above
  • Able to communicate in Cantonese and read Chinese
  • Have a smart mobile phone (IOS or Android System) with mobile internet access
  • Show interest to participate in an exercise program for smoking cessation

Exclusion Criteria:

  • Incapable to do short-bout exercises due to physical or psychological conditions
  • Pregnant
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02844296


Contacts
Contact: Tai Hing Lam, MD 852-3917-9287 hrmrlth@hku.hk

Locations
Hong Kong
Integrated Centre on Smoking Cessation, Tung Wah Group of Hospitals Recruiting
Hong Kong, Hong Kong
Contact: Helen Chan, MPH    +852 28271068    helen.ch.chan@tungwah.org.hk   
Sponsors and Collaborators
The University of Hong Kong
Tung Wah Group of Hospitals
Investigators
Principal Investigator: Tai Hing Lam, MD The University of Hong Kong
More Information

Publications:

Responsible Party: Professor Lam Tai-Hing, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02844296     History of Changes
Other Study ID Numbers: TWRCT2016
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Professor Lam Tai-Hing, The University of Hong Kong:
short-bout exercise
craving
handgrip
smoking cessation
RCT