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Trial registered on ANZCTR


Registration number
ACTRN12615000007538
Ethics application status
Approved
Date submitted
11/12/2014
Date registered
8/01/2015
Date last updated
8/01/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The feasibility and effectiveness of high-intensity boxing training versus moderate-intensity brisk walking in adults with abdominal obesity: A pilot study
Scientific title
The feasibility and effectiveness of high-intensity boxing training versus moderate-intensity brisk walking in adults with abdominal obesity: A pilot study
Secondary ID [1] 285829 0
Nil
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 293746 0
Condition category
Condition code
Diet and Nutrition 294079 294079 0 0
Obesity
Metabolic and Endocrine 294046 294046 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Boxing
Participants in the boxing group were prescribed four, 50-min sessions of supervised boxing training per week for 12 weeks. A boxing instructor assisted in designing the program. All sessions were fully supervised by qualified personnel and participants were trained individually. The interval-based exercises were preceded by a 5 min warm-up of continuous skipping at a self-selected intensity. Intervals were prescribed at 2:1 (i.e. 2 min of high-intensity activity followed by 1 min of rest (standing or pacing) between intervals and exercises). Three intervals of each of the following five exercises were performed for a total of 30 min of high-intensity effort: (1) heavy bag, (2) focus mitts, (3) circular body bag, (4) footwork drills, and (4) skipping. The total amount of physical activity (excluding warm up and rest periods) was computed as 30 min x 6 metabolic equivalents (MET) per minute = 180 MET min. During the high-intensity bouts, participants were instructed to exercise at a rating of perceived exertion of 15-17/20 (“hard” to “very hard”) with the goal of achieving >75% of age-predicted maximal heart rate (i.e. 220-age; HRmax).
Training intensity: Heart rate was monitored using a Polar Heart Rate monitor (Polar 'Registered Trademark' RS800sd Kempele, Finland) and was recorded at the completion of each high-intensity interval; these values were averaged across each week, and reported as percentage of age-predicted HRmax.
Intervention code [1] 290808 0
Treatment: Other
Comparator / control treatment
Walking
Participants in the walking group were prescribed four, 50-min sessions of brisk walking per week for 12 weeks. These sessions were unsupervised and completed in any location convenient to the participant (e.g. within their own neighbourhood, etc.). Participants were instructed to begin each session with a 5-min gradual warm-up and walk as quickly as possible for the remainder of the session (45 min). The total amount of physical activity (excluding warm up) was computed as 45 min x 4 metabolic equivalents (MET) per minute = 180 MET-min.
Training intensity: Participants were taught how to manually monitor their heart rate and record the measure pre-, mid- and post-exercise. These data were recorded in a training journal. The mid-exercise readings were averaged across each week, and reported as percentage of age-predicted HRmax.
Control group
Active

Outcomes
Primary outcome [1] 293865 0
Adherence: was defined as the number of sessions attended divided by the number of sessions offered multiplied by 100%.
Timepoint [1] 293865 0
Adherence was recorded throughout the 12-week intervention period in a standard log by the exercise trainer at the beginning of each training session in the boxing group. Adherence was self-recorded throughout the 12-week intervention period in a standard log by participants in the walking group.
Primary outcome [2] 293823 0
Recruitment rate
Timepoint [2] 293823 0
During the recruitment phase of trial
Primary outcome [3] 293864 0
Assessment of training intensities in boxing and walking groups. The training intensity in both groups was evaluated by the evaluation of heart rate (reported in beats/min). Heart rate in the boxing group was assessed by Polar Heart Rate Monitor 'Registered Trademark", while heart rate in the Walking group was self-assessed by monitoring the radial or carotid pulse.
Timepoint [3] 293864 0
Throughout the 12-week intervention period (during each training session). Heart rate in the boxing group was assessed at the end of each 2 min high-intensity interval. The walking group assessed their heart rate at the mid-point of their exercise sessions.
Secondary outcome [1] 311948 0
Body Mass Index: Height and weight were measured with calibrated scale (A&D Company Ltd., Japan) and stadiometer (Holtain Ltd., Crymych, UK), respectively, and BMI was computed from these measures
Timepoint [1] 311948 0
Pre and post intervention (week 0 and week 13)
Secondary outcome [2] 312032 0
Health-related quality of life (HRQoL): The Medical Outcomes Trust Short Form-36 Health Survey (Version 1.0) (SF-36) was used to evaluate Physical Functioning, General Health and Vitality domains of HRQoL. Higher scores, ranging from 0-100, denote higher HRQoL.
Timepoint [2] 312032 0
Pre and post intervention (week 0 and week 13)
Secondary outcome [3] 312028 0
Body fat percentage: Six skinfold sites (i.e. triceps, subscapular, supraspinale, abdominal, front thigh and medial calf) were recorded using Holtain callipers (Holtain Ltd., Crymych, UK) if the skinfold was less than or equal to 40mm and Slimguide callipers (Creative Health Products, Plymouth, USA) if the skinfold was >40mm. Body fat percentage was computed from the six skinfold sites using validated equations.
Timepoint [3] 312028 0
Pre and post intervention (week 0 and week 13)
Secondary outcome [4] 311947 0
Body Weight: was measured with calibrated scale (A&D Company Ltd., Japan) and stadiometer (Holtain Ltd., Crymych, UK), respectively
Timepoint [4] 311947 0
Pre and post intervention (week 0 and week 13)
Secondary outcome [5] 312030 0
Arterial stiffness (augmentation index): was assessed using the SphygmoCor System (AtCor Medical Pty, Sydney, Australia). This system derives the central aortic pressure waveform noninvasively from the pulse pressure recorded at a peripheral site. Participants were seated for a 10-min period, then radial pulse pressure waveform recording were obtained using a hand-held, high fidelity tonometer (Millar Instruments, Houston, Texas). The aortic pressure waveforms are comprised of a forward wave caused by left ventricular contraction and a reflected wave due to backflow arising from regions of increased impedance in the peripheral vessels. The resultant of these two pressures is known as the augmentation index (AIx) which was recorded. The SphygmoCor algorithm normalises AIx to a heart rate of 75 beats per minute. This method is highly reproducible and has been used extensively to evaluate arterial stiffness in healthy and chronically diseased cohorts. Population norms for AIx range from -23.27% to 63.07% in adults (aged 18-86 years) with larger values indicating greater arterial stiffness.
Timepoint [5] 312030 0
Pre and post intervention (week 0 and week 13)
Secondary outcome [6] 312031 0
Cardiorespiratory fitness (VO2max): was assessed via indirect calorimetry (Jaeger Metabolic Gas Analysers, Viasys Healthcare, Germany) using a standard ramp protocol on a laboratory treadmill (LE 200 CE, Viasys Health Care, USA). O2 and CO2 sensors were calibrated prior to each test using high-grade calibration gas with certified gas concentrations (O2=16%, CO2=5%, N2=balance). The protocol began at a pre-determined, comfortable walking speed for 3 minutes; the grade was increased by 2% each minute thereafter until volitional fatigue.
Timepoint [6] 312031 0
Pre and post intervention (week 0 and week 13)
Secondary outcome [7] 311946 0
Waist circumference: Waist circumference was measured in a horizontal plane, midway between the inferior margin of the ribs and the superior border of the iliac crest, according to standard protocol.
Timepoint [7] 311946 0
Pre and post intervention (week 0 and week 13)
Secondary outcome [8] 312029 0
Resting blood pressure (systolic/diastolic): was assessed manually at the brachial artery with the participant in a seated position according to standard protocols.
Timepoint [8] 312029 0
Pre and post intervention (week 0 and week 13)

Eligibility
Key inclusion criteria
Eligibility criteria: adult (>18 years); body mass index (BMI) >25kg/m2; abdominal obesity as a risk factor for cardiometabolic disease according to the International Diabetes Federation (i.e. waist circumference >94cm in men and >80cm in women); available to complete four exercise sessions per week; able to communicate in English; willingness and cognitive ability to provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
physically active (i.e. engaging in greater than 3 sessions of moderate-intensity exercise per week); current or history of ischaemic heart disease, cerebrovascular disease, type 2 diabetes mellitus, advanced metabolic disease (e.g. chronic kidney disease) or uncontrolled pulmonary disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants were recruited over a nine-week period from June 3 to August 2, 2013 by means of flyer advertisements, university staff email lists and social media (Facebook). The aim was to recruit two participants per week, on average. Randomization assignments were computer-generated (www.randomization.com) and stratified by gender, by an investigator not involved in data collection; assignments were given to participants in sealed envelopes upon the completion of baseline testing.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization assignments were computer-generated (www.randomization.com) and stratified by gender, by an investigator not involved in data collection; assignments were given to participants in sealed envelopes upon the completion of baseline testing.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Analyses were performed using the Statistical Package for the Social Sciences (IBM 'Copyright', SPSS Version 19.0). All data were inspected visually and statistically for normality (skewness and kurtosis between -1 and +1). Analyses were completed according to intention-to-treat strategy, using the last-observation-carry-forward imputation method for any missing data. Within group changes over time were evaluated by paired t-tests. Group x time effects were determined by analysis of covariance (ANCOVA) of the post-treatment score controlling for the baseline score and potential confounding variables identified by comparing groups at baseline. Cohen’s d effect sizes were calculated to explore the effectiveness of the intervention and provide data to inform sample size calculations in future studies. Effect sizes were interpreted according to the conventions of small (0.20), moderate (0.50), or large (0.80). A p value of <0.05 was considered indicative of statistical significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/06/2013
Date of last participant enrolment
Anticipated
Actual
2/08/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 9051 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 290401 0
University
Name [1] 290401 0
University of Western Sydney
Country [1] 290401 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
Locked Bag 1797, Penrith, New South Wales, 2751, AUSTRALIA
Country
Australia
Secondary sponsor category [1] 289120 0
None
Name [1] 289120 0
N/A
Address [1] 289120 0
N/A
Country [1] 289120 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292094 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 292094 0
Ethics committee country [1] 292094 0
Australia
Date submitted for ethics approval [1] 292094 0
25/02/2013
Approval date [1] 292094 0
22/03/2013
Ethics approval number [1] 292094 0
H10002

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53466 0
Dr Birinder Cheema
Address 53466 0
School of Science and Health, and the National Institute of Complementary Medicine, University of Western Sydney, Locked Bag 1797, Penrith, New South Wales, 2751, AUSTRALIA
Country 53466 0
Australia
Phone 53466 0
+61246203795
Fax 53466 0
Email 53466 0
B.Cheema@uws.edu.au
Contact person for public queries
Name 53467 0
Birinder Cheema
Address 53467 0
School of Science and Health, and the National Institute of Complementary Medicine, University of Western Sydney, Locked Bag 1797, Penrith, New South Wales, 2751, AUSTRALIA
Country 53467 0
Australia
Phone 53467 0
+61246203795
Fax 53467 0
Email 53467 0
B.Cheema@uws.edu.au
Contact person for scientific queries
Name 53468 0
Birinder Cheema
Address 53468 0
School of Science and Health, and the National Institute of Complementary Medicine, University of Western Sydney, Locked Bag 1797, Penrith, New South Wales, 2751, AUSTRALIA
Country 53468 0
Australia
Phone 53468 0
+61246203795
Fax 53468 0
Email 53468 0
B.Cheema@uws.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.