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临床试验/NCT04059497
NCT04059497已完成不适用

Efficacy of a Short-bout Handgrip Exercise Intervention for Reducing Nicotine Craving in Tobacco Users: 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 30 人开始时间: 2019年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Nicotine craving

研究概览

简要总结

This study aims to examine the effect of practicing short-bout handgrip and isometric exercises on nicotine craving, smoking urges and withdrawal symptoms in adult smokers undergoing acute tobacco abstinence. The study is a randomized controlled trial to test the effect of practicing a set of short-bout exercises (10-second exercise) on reducing nicotine craving and withdrawals. Smokers, who have been abstinent from tobacco use for 9 hours, will join a guided exercise session using 10s-E or a healthy-diet (HD, control) intervention session, and complete a craving assessment before and 2 assessments after the respective intervention session. Primary outcomes will be nicotine craving, smoking urges and withdrawal symptoms.

详细描述

The study is a randomized controlled trial to test the effect of practicing a set of short-bout exercises (10-second exercise) on reducing nicotine craving and withdrawals. Smokers, who have been abstinent from tobacco use for 9 hours, will join a guided exercise session using 10s-E or a healthy-diet (HD, control) intervention session, and complete a craving assessment before and 2 assessments after the respective intervention session.

  1. Target subjects

At recruitment stage (hotspot or telephone follow-up), smokers with the following inclusion criteria (Appendix 1) will be invited to participate in an intervention and assessment session:

  • Consume 10+ traditional cigarettes a day
  • Aged 18 years or above
  • Able to communicate in Cantonese
  • Self-reported no serious injury of hands and arms
  • Self-reported no mental illnesses

Before the intervention and assessment session, the invited participants will be assessed with the following eligibility criteria:

  • Self-reported no smoking in past 9 hours before the intervention session
  • Exhaled carbon monoxide <= 15 parts per million (ppm) or reduced by at least 50% compared to that measured at recruitment stage
  1. Procedures Our recruitment staff (research assistants or student helpers) will approach smokers at the outdoor smoking hotspots, and introduce the RCT to the smokers. Potential participants will be assessed with the eligibility criteria, and asked to test their exhaled carbon monoxide with a Bedfort Smokerlyzer to confirm their smoking status. If eligible, they will be asked to participate in the intervention and assessment session of this RCT.

Our telephone interviewers of other smoking cessation trials, which have similar eligibility criteria as the present trial, will ask their participants during their telephone interviews if they currently consume 10 cigarettes or more a day and other eligibility criteria. If eligible, they will also be invited to participate in the intervention and assessment session of this RCT.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, 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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Nicotine craving

时间窗: Baseline, immediate after intervention, 15-minute follow-up

How strong is your desire to smoke right now (Scale 1-7)

Smoking urge

时间窗: Baseline, immediate after intervention, 15-minute follow-up

10-item Questionnaire of Smoking Urges-Brief

Withdrawal sysmptoms

时间窗: Baseline, immediate after intervention, 15-minute follow-up

Mood and Physical Symptoms Scale

次要结局

未报告次要终点

研究者

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

Dr. Derek Yee-Tak Cheung

Assistant Professor

The University of Hong Kong

研究点 (1)

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