Short-bout Handgrip Exercise for Smoking Cessation

NCT02844296 | Completed DMC

• 1 other identifier: TWRCT2016
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

short-bout exercise; craving; handgrip; smoking cessation; RCT

Outcome Measures

Primary Outcomes (1)

• 4-week self-reported tobacco abstinence at 6-month follow-up

  4-week self-reported tobacco abstinence at 6-month follow-up

  6 months

Secondary Outcomes (7)

• Self-reported 7-day point prevalence abstinence

  2 and 6 months

• Grip strength measurement

  baseline, 1 month and 6 months

• Minnesota Nicotine Withdrawal Scale

  baseline, 2 and 6 months

• International Physical Activity Questionnaire

  baseline, 2 and 6 months

• Perceived effectiveness of using handgrip/healthy diet to relieve cravings for smoking

  2 months

Study Arms (2)

exercise group

EXPERIMENTAL

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; Behavioral: App about exercise; Behavioral: Leaflet about exercise

diet group

EXPERIMENTAL

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; Behavioral: App about diet; Behavioral: Leaflet about diet

Interventions

Video about exercise BEHAVIORAL

Video about short-bout exercise will be played for the participants.

exercise group

App about exercise BEHAVIORAL

A smartphone App about exercise will be installed in participants' mobile phone.

exercise group

Leaflet about exercise BEHAVIORAL

A leaflet about exercise will be provided for the participants.

exercise group

Video about diet BEHAVIORAL

Video about healthy diet will be played for the participants.

diet group

App about diet BEHAVIORAL

A smartphone App about healthy diet will be installed in participants' mobile phone.

diet group

Leaflet about diet BEHAVIORAL

A leaflet about healthy diet will be provided for the participants.

diet group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong: lead
• Tung Wah Group of Hospitals: collaborator

Study Sites (1)

Integrated Centre on Smoking Cessation, Tung Wah Group of Hospitals

Hong Kong, Hong Kong

Location

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MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Tai Hing Lam, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 26, 2016
• Study Start: October 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2018
• Last Updated: February 20, 2019

Record last verified: 2019-02

Locations

HK (1)