跳至主要内容
临床试验/NCT02844296
NCT02844296已完成不适用

Efficacy of a Short-bout Handgrip Exercise Intervention for Smoking Cessation: a Pilot Randomized Controlled Trial

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
208
试验地点
1
主要终点
4-week self-reported tobacco abstinence at 6-month follow-up

研究概览

简要总结

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.

详细描述

  1. Scientific / historical background

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. A recent systematic review of the RCTs using exercise for smoking cessation suggested that more trials with larger sample size, equal contact control conditions and measures of exercise adherence are needed to confirm its effectiveness .

Despite the effectiveness of various exercise interventions on smoking cessation, most previous RCTs required the participants to attend multiple guided exercise sessions for at least once per week consecutively for 6 to 12 weeks. Participants willing to join these sessions would have a very high motivation to quit, which might over-estimate the effect size and limit its applicability. These exercise sessions showed high compliance and effectiveness, but could only recruit very few participants who showed strong motivation to quit and had much time to attend. These interventions are unlikely to be directly applicable to the smokers in Hong Kong, who mostly prefer "self-determination" than using intensive smoking cessation services as the method of quit attempt .

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 . Some laboratory studies showed that short-bout (5-10 minutes) isometric exercises (e.g. jaw clenching or fist clenching) or moderate intensity exercise (e.g. stationary cycling) is effective to reduce craving and withdrawal symptoms. No published randomized controlled trials (RCT) on short-bout exercise for smoking cessation or relapse prevention from PubMed and Cochrane Library was found by the investigators.

Handgrip, which enhances training of hand-griping strength, is a common short-bout exercise tool used for lowering blood and arterial pressure . The advantages of handgrip exercise (HGE) are: (1) The equipment is simple to use and inexpensive; (2) It can be performed anytime anywhere; (3) No intensive training is needed; (4) Effects of HGE is immediate if any on relieving craving; and (5) Adherence to HGE shall be high as it is simple to use. Grip strength has been adopted as a fitness test for recruitment into the Hong Kong Police Force, and is shown as a good predictor of cardiovascular fitness and survival. Therefore, this exercise tool might also raise smokers' interest to initiate this simple and effective exercise for quit attempt.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

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

时间窗: 6 months

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

次要结局

  • International Physical Activity Questionnaire(baseline, 2 and 6 months)
  • The Smoking Self-Efficacy Questionnaire(12 months)
  • Biochemical validated abstinence(6 months)
  • Perceived effectiveness of using handgrip/healthy diet to relieve cravings for smoking(2 months)
  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Lam Tai-Hing

Professor

The University of Hong Kong

研究点 (1)

Loading locations...

相似试验

Short-bout Handgrip Exercise for Smoking Cessation | 临床试验