Smoking Cessation Clinical Trial
Official title:
Efficacy of a Short-bout Handgrip Exercise Intervention for Smoking Cessation: a Pilot Randomized Controlled Trial
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.
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.
Recently the research team has conducted a pilot study of delivering a short-bout
exercise (about 10 minutes) intervention session using a handgrip for the clients (n=31)
in the Integrated Centre on Smoking Cessation of Tung Wah Group of Hospitals and
evaluating the perceived effectiveness of this exercise. In the 31 clients, 18 (59.1%)
had smoking urges in the past 24 hours. Examples of the exercise were isometric griping
of the handgrip as long as possible and rapid grip-and-release movements. While only 2
clients agreed that these exercises can increase abstinence before our guided exercise
session, 12 post-session clients (38.7%) agreed it does. The participants perceived that
the exercises are beneficial for smoking cessation, because these exercises can be
conveniently performed for urge alleviation and distraction. On the other hand, the
results suggested several improvements in the delivery of intervention such as increase
in the exercise counselling for users with low perceived efficacy and use of handgrips
with higher strength value. Applicability can be increased by incorporating other
short-bout exercises, such as hand pushing and pulling, when handgrip is not available
for usage. Frequency of use and increase in grip strength will be documented as
indicators of exercise compliance, and additional benefits which may increase smokers'
motivation.
Short-bout exercise is a simple and low-cost behavior which only needs brief training by
non-healthcare professionals and takes very little time to practice. The effect size may
be small to moderate, but it has large impact as it can be disseminated easily to a
large number of smokers. A short-bout exercise intervention was proposed, with handgrip
mainly plus those without, to (1) reduce craving during the first month of cessation
treatment and (2) increase abstinence assessed at 6-month. The main barrier of adopting
such a small and easy behavior is inertia and forgetfulness. To increase the exercise
adherence, Anti-inertia Reminder (AIR) model was developed and several strategies to
assist the participants to overcome the inertia and forgetfulness.
2. Study design
The study consists of 3 phrases: (1a) Development of an educational video for the exercise
intervention; (1b) Development of a smartphone application ("App") for reminders and
electronic daily dairy; (2) Briefing session of ICSC counselors to introduce the brief
short-bout exercise intervention and RCT to the clients; and (3) A randomized controlled
trial to test the efficacy of delivering a brief short-bout exercise intervention for smoking
cessation.
2.1 Phase 1a - Development of an educational video for the exercise intervention
2.1.1 Objective
A short video will be produced (about 5 minutes) as a part of the exercise intervention for
the intervention group. It will be played in a tablet after the subjects in the intervention
group have given consent to participate at recruitment. The video will also be available in
the smartphone application so that he/she can watch it anytime.
2.1.2 Content
The video will (1) briefly deliver the knowledge of withdrawal symptoms during abstinence and
benefits of short-bout exercise for smoking cessation; (2) guide the participants to practice
the short-bout exercise, including those with or without the handgrip; (3) demonstrate the
scenarios that the subject can do the exercise during work and leisure time. The handgrip is
the main exercise, and the subjects should carry it along all day. Exercises without the
handgrip will be demonstrated when the handgrip is not nearby; (4) advise to do the
short-bout exercises as much as they can, or when they have craving.
2.2 Phase 1b - Development of a smartphone application
2.2.1 Objective
A smartphone application ("App") will be developed for automatically sending reminders of
doing handgrip exercise (or healthy diet) and entering data and an electronic daily diary.
All subjects will be asked to receive the reminders and enter data in the App for 4 weeks.
Subjects' identification number (last 5 digits of telephone number) are entered when the App
is installed on their mobile phones and used for the first time.
2.2.2 Reminder system
Subjects can set up a personalized and regular reminder schedule of exercises or diet in this
App. These reminders will be short text messages with sound, pictures or vibration to
motivate users to do the short-bout handgrip exercises or adopt a healthy diet. Subjects in
the intervention (exercise) group will be asked to respond to these reminders by either
selecting doing exercise at the moment or later. Once they select doing the exercise, a timer
will be shown for timing the exercise duration. All responses to the reminders and exercise
time will be recorded and uploaded to our server immediately as proxy measurements of
exercise adherence. The application will generate a report showing how much handgrip exercise
has been done each day by the subject so far. The sever for the App will detect if the
subjects have responded the reminders, and, if not responded for a week, will notify the
researchers to encourage them to try again. Subjects in the control (healthy diet) group,
will not be repaired to respond the reminders, but he reminder time and data will be
documented.
Subjects can also initiate the exercise timer to record the exercises anytime and anywhere.
All these actions and time will be uploaded to the server.
2.2.3 Data entry of craving and smoking
All subjects in the intervention/control group will record he smoking/quitting data via the
App. The App will "pop-up" a survey of 4 questions each day according to the participant's
setting: (1) How many cravings do you have today? The 4 options are none, 1-2 times, 3-9
times, and every hour. (2) How is your craving in the past 24 hours? The 5 options are none,
mild, fair, strong and very strong. (3) How many cigarettes do you smoke today? (4) Have you
used NRT products or varenicline today? The exact time of the short survey can be set by the
subject. All responses will be sent to our server and stored in the dataset immediately.
2.2.4 Other educational materials
The App will also contain the intervention videos and other relevant smoking cessation
materials.
2.3 Phase 2 - Briefing session of ICSC counselors to recruit subjects to the RCT
2.3.1 Objectives
The briefing session aims to empower the ICSC service providers to (1) measure handgrip
strength to encourage smokers to do exercise, (2) introduce the brief intervention of
motivating the clients to practice short-bout exercise with and without handgrip, on top of
their usual counselling.
2.3.2 Target service providers
All ICSC physicians, nurses, social workers and other healthcare professionals.
2.3.3 Briefing content
The two-hour briefing will include:
1. Simple motivation and empowerment of smokers to start and adhere to the exercise
2. Expected questions from smokers and suggested answers
3. Briefing on the operation of the randomized controlled trial
2.4 Phase 3 - Pilot randomized controlled trial (RCT)
2.4.1 Study design and objective
The single-blinded, 2-arm RCT aims to examine the efficacy of the short-bout exercise
intervention on reducing craving and increasing tobacco abstinence.
2.4.2 Target subjects
All ICSC clients who have enrolled in the smoking cessation service will be screened by the
counselor with the following eligibility criteria:
Inclusion criteria:
- Newly- or re-enrolled in the smoking cessation service of ICSC (which means existing
clients 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/healthy diet for smoking cessation
Exclusion criteria:
- Incapable to do short-bout exercises due to physical or psychological conditions
- Pregnant
2.4.3 Recruitment procedures
In the 1st face-to-face session of the cessation treatment, after the usual the ICSC
counselor will check the eligibility of each client for the participation of the RCT.
The counselor will briefly introduce the RCT of using short-bout exercise (treatment
condition for intervention group) and healthy diet (treatment condition for control group)
for smoking cessation, including follow-up schedule, and the incentives for the follow-up. If
they are interested, they will be asked to sign the consent form for the participation. After
the consent form, the counselor will invite them for measuring the grip strength with the
dynamometer according to a standardized protocol and show the handgrip to them. Three
measurements will be made for both hands of each participant. The maximum values obtained
from each hand will be used for analysis.
Then, baseline information related to the socio-demographics, smoking and quitting history
will be collected by the counselor (some information may have been collected in the standard
baseline questionnaire of ICSC). The counselor will randomize the subject to one of the RCT
groups by opening a sequentially numbered, opaque sealed envelopes (SNOSE method), followed
by the intervention delivery. After the enrolment session, the counselor will immediately
transfer the contact details of the participant and scan/send the documents (i.
questionnaire; ii. Consent form; iii. Video feedback form via WhatsApp /Email) to the HKU
research staff for follow-up. All baseline questionnaires and consent forms will be
transferred to the HKU School of Public Health every 2 weeks.
2.4.4 Intervention
Intervention group
After completion of the baseline questionnaire, each subject in the intervention group will
be given a free handgrip (strength 15 kg). Then, the counselor will play the short video for
the participant. The intervention group will be introduced one handgrip exercise to reduce
craving in the video:
- Rapid grip-and-release the handgrip for at least 30 times in 10-15 seconds in both
hands,
- And short-bout exercises without handgrip will also be included: Hand pushing and
pulling.
They will be encouraged to do these exercises when they have craving, or when the urge of
smoking is expected. They will also be encouraged to increase the frequency and intensity of
the exercise to increase the intensity to reduce craving as much as possible, and to increase
their grip strength.
After the video, the counselor will assist the subject to install the App in mobile phone,
set up the 4-week reminder schedule and electronic daily diary, and fill in the video
feedback form. A leaflet with exercise instruction and motivation messages based on the
Health Action Process Approach (HAPA) will be given to the participant.
Participants may not practice the exercise they have learned recently due to inertia, even
they are interested. To break this inertia, the Anti-inertia Reminder (AIR) has been
developed with several approaches in designing the intervention (1) aim to motivate each
participant to do it quickly whenever they have craving, and do it every hour at least even
without craving. (2) The participants are requested to make sure that the handgrip is always
seen and accessible as a craving relieving "alarm". The subjects will be suggesting carry the
handgrip all day and placing at an eye-catching place such as on the desk and on the dinner
table. (3) Participants are required to use the smartphone application and activate the alarm
setting in the 4 weeks after the baseline intervention. The participants could set a
convenient time to finish the daily questionnaire. All the exercise reminders are designed
based on the refined taxonomy of behavioral change techniques for physical activity in order
to enhance and strength the future scientific reporting of the intervention.
Control group The control group will view a 6-minute 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 o set up healthy die reminder schedule for 4 weeks. They
will be given a leaflet on healthy diet, and 20-30 reminders on healthy diet and quitting
tips via the App for 4 weeks.
Apart from all these interventions, all participants will receive usual cessation treatment
in ICSC.
2.4.5 Outcomes
The primary outcomes are the 4-week self-reported smoking records for 4 weeks.
The secondary outcomes are the biochemically validated abstinence and self-reported
abstinence in the past 7 days at 6-month follow up. Biochemical validated abstinence will be
assessed with a Smokerlyzer, and exhaled carbon monoxide (CO) below 4ppm was defined as
validated quitter. HK$50 will be offered to each client to cover their travel expense and
time cost. Subjects who reported that they had quit smoking at 6-month follow up and had not
use any type of nicotine replacement therapy will be invited to take a self-report
biochemical validation which includes measurements of saliva cotinine. The measurement kits
will be delivered to those subjects by mail. An incentive of HK$50 will then be offered to
quitters who have reported the test results to the researcher. The subjects will be contacted
via telephone at 2-,6- and 12-month to conduct assessment of the following outcomes :
self-reported 7-day point prevalence abstinence, the Minnesota Nicotine Withdrawal Scale
(MNWS) ,the International Physical Activity Questionnaire (IPAQ) , perceived effectiveness of
handgrip in relieving craving (5-point Likert scale) and questionnaire of surgery drinks
weekly intake. The 12-item Smoking Self-Efficacy Questionnaire (SEQ-12) will be added into
the 12-month follow-up questionnaire only. Grip strength within the first two months after
enrollment will be measured. Follow-ups will be measured by the ICSC counselors or HKU staff.
Craving frequency, intensity and exercise adherence including frequency and duration will be
entered to the App by the subjects. The mean number of days reporting smoking after craving
in the 4 weeks after the enrolment, which will be assessed with 2 questions on a daily basis:
(1) presence of craving (2) presence of smoking. At the enrolment, all participants will be
introduced how to enter these information to the App on a daily basis during the first 4
weeks of their participation.
The 2-,6- and 12-month follow-up will be conducted when they visit the ICSC or through
telephone, by a HKU research staff blinded to the group allocation. Incentive of HK$50 will
be provided for their participation in each follow-up.
2.4.6 Research hypothesis
The intervention group will have a significantly greater decline of the craving frequency and
intensity, a higher 4-week self-reported quit rate at 6-month follow-up than the control
group, and less mean number of days reporting relapse.
2.4.7 Effect size estimation
As a pilot RCT to examine the effect size of the exercise intervention for smoking cessation,
a total of 200 (each group 100) subjects will be targeted. Assuming the 6-month quit rate for
the intervention and control group was 60% and 50% (based on previous data, odds ratio =
1.5), the power for the significant z-test will be 30%. The power will be 70% if the sample
size is 600.
2.4.8 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. The primary investigator will prepare 384
identical, opaque, sealed, A5-sized envelops, with a unique 2-digit number with the centre
name 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. The
envelopes will be distributed to the 8 ICSC (48 envelopes in each ICSC). The ICSC counselor
must open the envelopes following the sequence number on the envelope for the randomization
procedure. The primary investigator and the HKU research staff will not be involved in the
randomization of subjects.
Both the counselors and the subjects are not blinded from the behavioral intervention, but
the outcome assessors (HKU research staff) at the 2- and 6-month follow-up are blinded from
the group assignment.
2.4.9 Drop-out
Subjects can choose to drop out from the RCT during the study period, without any penalties
or administrative procedures. If the subjects refuses to continue the intervention during the
enrolment or the baseline intervention, the reasons of the drop-out should 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.
2.4.10 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. Chi-square tests will be
used to compare categorical variables between subgroups. Complete case analysis will be done
as a sensitivity analysis. Descriptive statistics including frequency, percentage, and mean
will be used to summarize the outcomes and other variables. For the quitting outcomes
assessed at the 2- and 6-month follow-up, logistic regression and linear regression will be
used to examine the predictors. The Kolmogorov-Smirnov test will be used to determine the use
of t test (normal distribution) or Mann-Whitney U test (non-normal distribution) for the
comparison of continuous variables. General linear model repeated measures analysis (ANOVA)
will be used to examine the changes of psychosocial variables and grip strength. To compare
the number of days reporting relapse after craving in the first 4 weeks (assessed via the
app) between the 2 groups, independent sample t-test will be used. For the daily outcomes
including craving frequency, craving intensity and cigarette consumption (assessed via the
app), 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; exercise,
for intervention group only) and interaction effect (group X day; exercise X day, for
intervention group only) will be analyzed.
3. Consent
Participation in the study is voluntary. The ICSC staff at the clinics will explain to the
potential subjects who agree to join the RCT that carried out RCT on smoking cessation. The
smoking cessation counselors will explain to the subjects that they will receive telephone
follow-ups at 2 months, 6 months and 12 months to enquire their smoking status. The subjects
will be assured that they can withdraw from the study anytime without any prejudice, and all
the information will be kept confidential and results will be reported in an aggregate
format. Subjects are required to sign the written consent form.
4. Ethics
Ethics approval will be sought from the Institutional Review Board of the University of Hong
Kong / Hong Kong Authority Hong Kong West Cluster.
5. Direct access to source data/documents
The App will only request the participants to enter research data, and the last four digital
numbers of their telephone for identification. The raw data will be stored in an external
hard-disk and locked in a cupboard with keys kept by the Principal Investigator. Only the
Investigators and research assistant of the project will be permitted to access the raw data
and/or study records. The data will be scanned and kept for 10 years or longer after the
study is completed. Individual participants will not be directly identifiable from the
dataset to be used for analysis.
;
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