Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04059497 |
| Other study ID # |
Handgrip pilot |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 15, 2019 |
| Est. completion date |
June 30, 2020 |
Study information
| Verified date |
November 2020 |
| Source |
The University of Hong Kong |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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
2. 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.
If all these participants agree to participate, the recruitment staff will arrange an
intervention and assessment session for these participants, and request them to be
abstinence from tobacco products for at least 9 hours before joining the intervention
and assessment session.
At the intervention and assessment session, the principle investigator (PI) will firstly
measure the exhaled carbon monoxide and ask if the participant has been abstinent for 9
hours. If eligible, they will provide a written consent (Appendix 2), complete a
baseline questionnaire (Appendix 3) (administered by the PI), and will be allocated
randomly to one of two conditions: exercise or healthy-diet. All intervention and
assessments will take around 40 minutes to complete. All participants will be given
HK$350 shopping vouchers after completing all intervention and assessments.
3. Interventions: Exercise condition 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 (Appendix 4a, administered by a RA blinded to group allocation).
4. HD intervention (Control) The control group will watch two videos on healthy diet
(https://www.youtube.com/watch?v=3v1vF_zrpAc and
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 (Appendix 4b,
administered by a RA blinded to group allocation).
5. 15-minute follow-up After the post-intervention measurement, both groups are asked to
watch another 10-minute of health education videos about nicotine craving
(https://www.youtube.com/watch?v=NpbxHj3_qns) and healthy diet (
https://www.youtube.com/watch?v=V4wyRsl8mls), and then complete another set of
post-intervention questionnaire (Appendix 5, administered by a RA blinded to group
allocation).
6. Outcomes Socio-demographic characteristics, smoking history and the Fagerström Test for
Nicotine Dependence (FTND) [18] will be collected at the recruitment stage. At the
intervention and assessment session, nicotine craving, smoking urges and withdrawal
symptoms are assessed to examine the physiological effect at baseline. Nicotine craving
will be assessed with a 7-point (1-not at all, 4-somewhat, 7-extremely) scale item: "How
strong is your desire to smoke right now" (West & Hajek, 2004). Smoking urge will be
assessed with the 10-item Questionnaire of Smoking Urges-Brief (QSU-brief) (Yu et al.,
2010). Withdrawal symptoms were measured with Mood and Physical Symptoms Scale (MPSS),
including 7 components: 'irritable', 'restless', 'hungry', 'poor concentration',
'stress', 'tension', and 'depressed' (West & Hajek, 2004). Respondents can select 1
option from 5 levels (1=strongly disagree, 5=strongly agree) in each component.
The follow-up questionnaire also includes the following questions on the satisfaction of
the intervention: (1) How much would you like the intervention video? (Scale 1-5; 1
indicates strongly dislike and 5 indicates strongly like); (2) How much do you
understand the intervention? (Scale 0-10; 0 indicates totally not understand it and 10
indicates totally understand it); (3) Would you agree that the intervention help
quitting? (Scale 1-5; 1 indicates totally disagree and 5 indicates totally agree); (4)
Are you confident to do 10s-E (exercise group) / have healthy diet (diet group)? (Scale
0-10; 0 indicates totally no confidence and 10 indicates strongly confident); (5) Do you
agree you have a real plan to quit with 10s-E (exercise group) / healthy diet (diet
group)? (Scale 0-10; 0 indicates strongly disagree and 10 indicates strongly agree); (6)
Do you think quitting by 10s-E (exercise group) / healthy diet (diet group) is
difficult? (Scale 0-10; 0 indicates totally no difficulty and 10 indicates strongly
difficult); (7) Will you introduce this video to other people? Options are yes or no;
(8, exercise group only) Have you followed the exercise demonstration just now in the
video? Options include "Not followed totally", "I followed a little bit", "I followed
most of all", and "I followed all"; and (9) Do you agree that 10s-E (exercise group) /
health diet (diet group) reduced their craving (Scale 1-5; 1 indicates strongly disagree
and 5 indicates strongly agree).
7. Research hypothesis The exercise group will have a significantly greater decline of the
craving, smoking urges and withdrawal than the control group assessed post-intervention
and 15 minutes after the intervention.
8. Effect size estimation The sample size calculation is based on the score of desire to
smoke (Scale 1-7). Assuming the group difference in mean change of smoking desire is
0.75 (Ussher et al., 2009), a significance level of 1%, statistical power 90%, a sample
size of 30 participants (15 each group) is needed to detect a difference between the two
groups.
9. Randomization, allocation concealment and blinding Simple individual randomization
method by sequentially numbered, opaque sealed envelopes (SNOSE) will be used to ensure
the counselors and the participants will be blinded from the allocation sequence before
the group allocation (Chan et al., 2013; Doig & Simpson, 2005). The primary investigator
will prepare about 50 identical, opaque, sealed, A5-sized envelops, with a unique
3-digit number on the cover of each envelope as an identifier. Then he will create a
random sequence list of the intervention or control group, and each group allocation
will be sequentially numbered that is matched with the envelope identifier. A paper
indicating the treatment condition will be inserted into each envelop, according to the
random sequence list.
Both the PI and the participants are not blinded from the behavioral intervention, but
the outcome assessors (HKU research staff) at the 2 post-intervention follow-up are
blinded from the group assignment.
10. Drop-out Participants can choose to drop out from the RCT during the study period,
without any penalties or administrative procedures. If the participants refuse to
continue the intervention during the intervention and assessment session, the reasons of
the drop-out will be documented by the counselor and reported to the HKU research staff
on the same day. The envelopes of the drop-out participants will not be re-used for
other participants.
11. Statistical analysis Data will be entered into SPSS for Windows (version 20) for
analysis. By intention-to-treat (ITT) analysis and worst case scenario, participants who
lost to follow-up or refused the follow-up will be treated as smokers. Descriptive
statistics including frequency, percentage, and mean will be used to summarize the
outcomes and other variables. For the desire to smoke, QSU-brief and MPSS, linear mixed
models which allow for multiple observations between subjects and account for clustering
of data within subjects will be used. Both the main effect (group allocation) and
interaction effect (group X time) will be analyzed.
