NCT04059497

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 16, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 15, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

5 months

First QC Date

August 12, 2019

Last Update Submit

November 2, 2020

Conditions

Keywords

CravingSmoking urgeWithdrawalNicotineExerciseIsometricHandgrip

Outcome Measures

Primary Outcomes (3)

  • Nicotine craving

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

    Baseline, immediate after intervention, 15-minute follow-up

  • Smoking urge

    10-item Questionnaire of Smoking Urges-Brief

    Baseline, immediate after intervention, 15-minute follow-up

  • Withdrawal sysmptoms

    Mood and Physical Symptoms Scale

    Baseline, immediate after intervention, 15-minute follow-up

Study Arms (2)

Exercise group

EXPERIMENTAL

The exercise group will receive a 10-minute exercise intervention.

Behavioral: Exercise condition

Healthy diet group

EXPERIMENTAL

The healthy diet group (control) will receive a 10-minute healthy-diet intervention.

Behavioral: Healthy diet condition

Interventions

Each participant in the intervention group can freely choose a handgrip of strength from 10 to 25kg which can be gripped with adequate grip strength. The PI will play the short video (5 minutes, www.youtube.com/watch?v=mZex2Wwy3fU) about the 10s-E for the participant, including (1) rapid grip-and-release the handgrip for at least 30 times in 10seconds in each hand, and (2) short-bout hand pushing and pulling exercises without handgrip. During the video, participants are asked to follow the 10s-E demonstrated by the medical professor. After the video, the PI will guide the participant to repeat the 10s-E for 5 times within the next 5 minutes. If participants feel pain in their hands, they can slow down the exercise. Between each exercise set, rest time for 10-20 seconds will be allowed. After practicing all these exercises, participants are asked to complete a post-intervention questionnaire

Exercise group

The control group will watch two videos on healthy diet (https://www.youtube.com/watch?v=w\_u4BYV2Okc). Similar to the 10s-E condition, they will complete a post-intervention questionnaire after the two videos.

Healthy diet group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tung Wah Group of Hospitals

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Zhang MJ, Cheung YTD, Wang Q, Cheng CCW, Luk TT, He WJ, Wang MP, Lam TH. Efficacy of simple and very brief handgrip and isometric exercises for reducing withdrawal symptoms in cigarette smokers: A pilot randomized controlled trial. Tob Induc Dis. 2024 May 24;22. doi: 10.18332/tid/187839. eCollection 2024.

MeSH Terms

Conditions

SmokingBehavior, AddictiveMotor Activity

Condition Hierarchy (Ancestors)

BehaviorCompulsive BehaviorImpulsive Behavior

Study Officials

  • Derek Cheung, PhD

    School of Nursing, HKU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 12, 2019

First Posted

August 16, 2019

Study Start

September 15, 2019

Primary Completion

January 31, 2020

Study Completion

June 30, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

The data are available upon request made to the principal investigator.

Shared Documents
STUDY PROTOCOL, SAP

Locations