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Study
design
The study was a randomized placebo- controlled trial. Baseline testing
and primary outcomes (DXA-derived body composition) as well as questionnaires
were double-blind at both time-points. Secondary anthropometric outcomes
and adverse events were single-blind (subject only, as control group was
placebo exercise). Ethics approval was obtained from The Children's Hospital
at Westmead (CHW) and The University of Sydney, Australia. This trial
was registered with the Australian New Zealand Clinical Trials Registry
(ANZCTR: 012605000716662)
The primary outcomes were percent body fat (BF) and android fat mass,
measured using dual-energy X-ray absorptiometry (DXA), which is relatively
low-cost (Park et al., 2002),
simple (Ogle et al., 1995),
and involves minimal exposure to radiation (Ogle et al., 1995,
Park et al., 2002).
Sample size was based on total body fat mass, as comparable estimates
in the literature were available, in contrast to the android adiposity
measurement. Based on previous research (Ferguson et al., 1999;
Gutin et al., 1997;
Owens et al., 1999),
we hypothesized that total BF would decrease more in the KF group than
in the placebo group with changes ± SD of -2.8 ± 4.0% in the KF group
and -0.2 ± 2.91% in controls, corresponding to a mean effect size of 0.9.
Power (beta) was set at 0.80, and alpha at 0.05, which determined that
a total sample size of 40 was needed. An average dropout rate of 5% (Ferguson
et al., 1999;
Gutin et al., 1997;
Owens et al., 1999)
was factored in, resulting in a total sample size requirement of 42.
Eligibility
and exclusion criteria
Included were subjects who were in school years 6 to 12, overweight/obese
(International BMI cut-off points for children aged <18 y, based on
age and gender) (Cole et al., 2000),
and sedentary (not partaking in >2 h.wk-1 of regular, organized physical
activity/sports or exercise (excluding compulsory physical education classes)
within the last 4 months. Subjects had no previous experience with martial
arts of any style within the past year, nor any other commitments that
interfered with their participation in all scheduled exercise and testing
sessions.
Subjects were excluded if they had: any cognitive, visual, mobility, or
congenital/genetic/growth impairment or disorder; any condition that might
be worsened by the exercise or testing procedures; type 1 diabetes; amputation
proximal to the fingers and/or toes; or if they had fractured a limb within
the past six months. Subjects who were participating in other research
studies which might affect or be affected by their participation in the
current study, as well as those who were pregnant were also excluded.
Recruitment
and screening
Subjects were recruited from CHW as well as from the general community
via advertisements, referrals, and word-of-mouth. Those who were interested
in joining contacted the assessor and underwent an interview over the
telephone. A "Telephone Screening Form" was used by the assessor
(TWT) to guide the interview, which was developed for the trial based
on the inclusion and exclusion criteria. Subjects who were deemed potentially
eligible after this interview were invited to attend the study clinic
for baseline measurements and a physical examination (and maturation assessment
using the Tanner method (Faulkner, 1996;
Tanner, 1981)
by the study physician (MK). Informed consent was obtained from subjects
and their parent/guardian at the first assessment session also.
Outcome
measures
Body composition: The primary outcomes were total BF (CV = 0.19%)
and android (abdominal) fat, measured using DXA (GE Lunar Corp, Madison,
WI). The android region (coefficient of variation, CV = 1.45%), was defined
by the software (version 8.6) as being 1/5th the trunk height, with the
inferior border placed on the iliac crests. The width of the region was
equal to the width of the trunk at that level. Secondary DXA outcomes
included percent BF, total and percent lean body mass (LBM) (CV = 0.16%),
arms LBM (CV = 0.52%), legs LBM (CV = 0.47%), and bone mineral density
(BMD) of the femoral neck (CV = 1.22%), lumbar spine (L2 - L4) (CV = 0.28%),
and whole body (CV = 0.06%). Only in the presence of an abnormality in
the dominant femoral neck (e.g., metal pin implant), was the non-dominant
side scanned. For subjects who were too wide for the scan bed, their arms
were tightly bound using a transfer sheet. At times the technician additionally
had to physically hold the subjects' bound arms in place to ensure their
entire body remained within the boundaries of the scan bed.
Fasting anthropometric measures obtained included height (CV = 0.05%),
weight (CV = 0. 05%), and waist circumference (CV = 0.11%). Height and
waist circumference (using the International Standards for Anthropometric
Assessment protocol (Norton et al., 1996))
were measured in triplicate to the nearest millimetre, and additional
measures were taken if any two measurements deviated >1 cm from each
other.
Questionnaires: Instructions and rationale for all questionnaires
were first explained to the subjects, before they were asked to answer
the questions themselves. They were encouraged to ask the assessor if
they had any questions.
Weekly status check: Each week throughout the six-month training
period, each subject was asked to complete a Weekly Status Check questionnaire
during the exercise session. The questionnaire asked subjects to provide
details about any illnesses, injuries, or new symptoms they may have experienced
during the previous week, any changes in their medications, visits to
health care professionals, and reasons for any missed exercise sessions.
These questionnaires were completed via interview over the phone if a
subject did not attend the sessions during a given week. These questionnaires
were also used to capture adverse events and changes in health status,
related or unrelated to study participation. Possible adverse events defined
a priori included new physical or mental symptoms of any kind, and any
injuries sustained during or outside of the training sessions.
Patient satisfaction (follow-up only): A multiple choice questionnaire
was created for this study, asking subjects how much they agreed or disagreed
(on a 5-point Likert scale) with statements referring to aspects of the
exercise classes. Included were statements about how difficult it was
to perform the movements and attend all exercise classes, if subjects
felt physically or emotionally better after the training period, and if
they would recommend this form of exercise to their friends.
Covariates
Nutritional intake and habitual physical activity were monitored over
5 - 7 consecutive days (including a weekend) at baseline and follow-up.
Subjects and their parents/guardians were asked not to change what activities
they normally did or what they normally ate. Parents/guardians were asked
to assist with the data recordings if necessary, and to ensure proper
use and maintenance of the monitoring devices. The assessor provided demonstrations
and instruction sheets for all devices.
Habitual physical activity: Habitual physical activity was reported
using the PACE+ (Patient-centred assessment and counselling for exercise)
questionnaire (Prochaska et al., 2001),
enquiring about the frequency and duration of any moderate to vigorous
physical activity habits (MVPA) over the previous seven days. Trial exercise
sessions were not to be included when answering this questionnaire.
Dietary intake: Self-reported food and drink intake was recorded
using CONIA digital MP3 players with voice recording capabilities (Model:
CMP51206, Pebble Electronics Pty Ltd, Knoxfield, Vic), similarly to previously
reported (Van Horn et al., 1990).
Whenever subjects consumed any food/drink, they were to record the date,
time, food/drink description (name/brand/cooking method), and quantity
consumed, including details of any condiments and water intake. Parents/guardians
were asked to help also, especially in cases where they prepared the meal.
If subjects did not want to take the MP3 player to school (in fear of
losing it or having it confiscated), they were instructed to write the
information down on a piece of paper. They could either record it into
the MP3 player at home after school or give the assessor the written logs
also.
Data recorded on MP3 players were downloaded and transcribed by the assessor,
who contacted the subject again for clarification of details if any recordings
were unclear. Food/drink data were analyzed for macronutrient composition
using AusNut Database from the Foodworks Professional Edition software,
version 3.02.581 (Xyris Software (Australia) Pty Ltd, Highgate Hill, Qld).
Average energy, protein, fat (total, saturated, polyunsaturated, and monounsaturated),
cholesterol, carbohydrates, sodium, and sugars consumed were recorded,
and also proportion of energy contributed by intake of protein, fat, and
carbohydrate.
Randomisation
Subjects were randomly assigned to either the KF or TC (placebo- exercise-control)
group after completing all baseline assessments. Randomisation was performed
by a researcher (MFS) who had no contact with any of the subjects, using
a computer randomisation program (Dallal, 2003).
Subjects were stratified by gender and BMI category (overweight vs. obese).
After randomisation, MFS informed the assessor (TWT) of the subject's
group allocation, and the subject was informed via telephone by the assessor.
Training interventions
Both groups were offered three, one-hour sessions each week of either
TC or KF training, over a period of six months. Classes were held by one
instructor per class, and TC and KF classes were held at the same time,
in different rooms within the hospital to avoid contamination, by subjects
seeing what was happening in the other group's sessions. All sessions
began with warm-up exercises specific to the martial art, and a short
(1 - 2 min) drink break was provided in the middle of each session. All
instructors were told to refrain from providing any lifestyle, behavioural,
or dietary advice, and to also avoid encouraging (or even mentioning)
home practice of the exercises taught. Attendance was recorded by the
instructors at each session, while adverse events (whether or not related
to study participation) were reported by subjects each week via questionnaire
or telephone interview (for those who did not attend in a given week).
Kung Fu sessions: The KF group was taught basic KF techniques of
the Choy Lee Fut Hung Sing Gwoon style. Training involved non-contact
technique practice and technique practice on focus mitts and kicking shields,
and learning and practice of basic forms. Sessions were usually intermittent
in nature, as the instructor often needed to stop the class to correct,
demonstrate, and explain techniques. As an estimate, sessions would have
been active for a minimum of approximately 40 min (out of 60 min). All
KF sessions were generally run by the same instructor.
Tai Chi sessions: TC has previously been shown to have no effect
on metabolic outcomes or body composition (Tsang et al., 2008),
so was used in this trial as the placebo exercise. Yang style TC was selected,
because its broad, aesthetically-pleasing movements were thought to be
more appealing to our young cohort than other TC styles. The Yang 24 forms
were taught progressively to the TC group, with quiet Chinese music playing
in the background. The TC instructors were externally-hired from a TC
school, so sessions were run by a select group of instructors, depending
on each individual TC instructor's availability.
Statistical
analysis
Statistical analyses were performed using Statview, version 5.0 (SAS Institute,
Cary, NC). All data were visually and statistically inspected for normality
of distribution. Non-normally-distributed data were log-transformed, or
if necessary, transformed using 1/x. All values were reported as mean
± SD; non-normally-distributed data reported as median (range). Baseline
comparisons (mean differences, confidence intervals (95% CI), t tests,
and chi square tests) and changes over time between groups were compared
using repeated measures analysis of variance (ANOVA) for continuous variables.
Variables with statistical or clinically meaningful differences between
groups at baseline and potentially related to the outcome of interest
were used as covariates in models. All analysis of covariance (ANCOVA)
models for change scores included the baseline scores for that variable
and attendance. Change scores and SD at six months were used to calculate
weighted mean differences, 95% CIs, and Hedge's bias corrected effect
size (ES) (Hedges and Olkin, 1985)
for each group. A p value of <0.05 and 95% CI excluding 0 were accepted
as statistically significant. Robustness of effects was assessed by calculating
ES (<0.2 = negligible; 0.2 - 0.5 = small; >0.5 - 0.8 = moderate;
and >0.8 = large (Cohen, 1988))
and clinical meaningfulness (by comparing changes to the literature) of
any changes observed. Forward stepwise multiple regression analyses were
performed using variables which were significantly related to the dependent
variable in univariate analyses to determine independent contributions
to variance. An all available data design (subjects included if they had
baseline and final assessments, regardless of attendance rate) was selected
rather than an intention-to-treat design (ITT), due to the novelty of
this efficacy trial. Data collected from subjects who did not complete
all training sessions were still included in the analyses, as per the
all available data statistical strategy. Thus, the results reflect the
effects of the treatments on subjects regardless of compliance with the
exercises sessions, in those in whom follow-up data was obtained. Missing
follow-up data were not imputed.
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