Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001619134
Ethics application status
Approved
Date submitted
13/11/2019
Date registered
22/11/2019
Date last updated
22/11/2019
Date data sharing statement initially provided
22/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
HART: High-intensity Aerobic and Resistance Training for metabolic syndrome.
Scientific title
High-intensity Aerobic and Resistance Training for metabolic syndrome.
Secondary ID [1] 299800 0
None
Universal Trial Number (UTN)
NA
Trial acronym
HART
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Metabolic syndrome 315175 0
Condition category
Condition code
Metabolic and Endocrine 313490 313490 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Walking
Participants will undertake treadmill walking for 30 minutes at 70% of age-predicted maximum heart rate (based on the formula 220 – age), conducted 3 days/week for 12 weeks. All sessions will be supervised by an Accredited Exercise Physiologist who is a study investigator. All sessions will be conducted in laboratories in the Wallace Wurth Building, UNSW Sydney. Treadmill speed/grade will be individualised to the participant and titrated accordingly to maintain the target rate. Heart rate responses will be monitored via continuous heart rate monitoring will a Polar H10 monitor.

Intervention compliance will be measured as how many of the of sessions the participant attends during the 12 weeks.

In addition, participants will receive advice based on current physical activity guidelines to complete >150 minutes of moderate-intensity physical activity per week, described as activity that “increases your breathing and heart rate but still allows you to maintain a conversation.” Participants will receive a diary to record their physical activity outside of the program during the study.

Arm 2: Stairs
Participants will undertake 5 x 20 second intervals of ascending/descending a single flight of stairs “as quickly but as safely as possible” in the Wallace Wurth Building at UNSW Sydney, conducted 3 days/week for 12 weeks. Participants will undertake a warm up of 3 minutes of brisk walking on flat ground in the corridor located next to the stairwell. Following each bout of stair climbing, participants will rest for 100 seconds. Following the last bout of stair climbing, participants will complete 3 minutes of walking on flat ground in the corridor. The total session time is 15 minutes. All sessions will be supervised by an Accredited Exercise Physiologist who is a study investigator. Heart rate responses will be monitored via continuous heart rate monitoring will a Polar H10 monitor.

Intervention compliance will be measured as how many of the of sessions the participant attends during the 12 weeks.

In addition, participants will receive advice based on current physical activity guidelines to complete >150 minutes of moderate-intensity physical activity per week, described as activity that “increases your breathing and heart rate but still allows you to maintain a conversation.” Participants will receive a diary to record their physical activity outside of the program during the study.
Intervention code [1] 316054 0
Treatment: Other
Comparator / control treatment
Home
Participants in the Home will receive advice based on current physical activity guidelines to complete >150 minutes of moderate-intensity physical activity per week, described as activity that “increases your breathing and heart rate but still allows you to maintain a conversation.” Participants will receive a diary to record their physical activity during the study and all participants in the Home group will be followed up every 2 weeks via email or phone to maintain contact with the study investigators.
Control group
Active

Outcomes
Primary outcome [1] 321953 0
Change in cardiorespiratory fitness, indicated by VO2peak, measured via indirect calorimetry during a graded exercise test on the treadmill. VO2peak will be measured with a gas exchange mask and Medgraphics Ultima metabolic cart. The graded exercise test will follow the modified Bruce protocol. The value used in statistical analysis will be the highest 15-second average during the last minute of exercise, where heart rate >85% age-predicted maximum heart rate and respiratory exchange ratio >1.0.
Timepoint [1] 321953 0
pre-intervention commencement and ~1 week post-intervention.
Secondary outcome [1] 376786 0
Waist circumference, measured in triplicate to the nearest centimeter on bare skin at the mid-point between the iliac crest and the lower rib margin during the expiratory phase of normal breathing, with the three-measure average used in analysis.
Timepoint [1] 376786 0
pre-intervention commencement and ~1 week post-intervention.
Secondary outcome [2] 376787 0
Blood pressure, measured with a brachial sphygmomanometer following 10 minutes of rest in a supine position.
Timepoint [2] 376787 0
pre-intervention commencement and ~1 week post-intervention.
Secondary outcome [3] 376788 0
Triglyceride levels, assays performed on plasma. Venous blood samples obtained following a 10-hour fast. Assays performed using standard procedures on a Beckman Coulter AU480 chemistry analyser.
Timepoint [3] 376788 0
pre-intervention commencement and ~1 week post-intervention.
Secondary outcome [4] 376789 0
High-density lipoprotein cholesterol levels, assays performed on plasma. Venous blood samples obtained following a 10-hour fast. Assays performed following precipitation of low-density lipoproteins on a Beckman Coulter AU480 chemistry analyser.
Timepoint [4] 376789 0
pre-intervention commencement and ~1 week post-intervention.
Secondary outcome [5] 376790 0
Fasting glucose levels, assays performed on plasma. Venous blood samples obtained following a 10-hour fast. Glucose levels measured via colorimetry at OD 570 nm using a commercial kit (Abcam®, Cambridge, UK).
Timepoint [5] 376790 0
pre-intervention commencement and ~1 week post-intervention.

Eligibility
Key inclusion criteria
Adult males and females over the age of 18 who meet the IDF/AHA (2009) criteria for diagnosis of the metabolic syndrome.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Adults with diagnosed cardiovascular disease, renal disease or diabetes.
• Adults who display an abnormal response to intense exercise (as seen during the exercise test).
• Adults who are unable to speak English and do not have a translator.
• Adults with orthopedic or neuromuscular limitations or self-perceived reasons that prevent them from performing the prescribed exercise.
• Adults who are unable to climb stairs or walk on flat ground at a moderate to high intensity (>70% maximum heart rate)

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)
Allocation involved contacting the holder of the allocation schedule who was “off-site” or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was estimated in G*Power version 3.1.9.2 using data change in CRF over 12 weeks from Tjonna et al. (2008), the study deemed most similar to The HART Project. Over 16 weeks, HIIT, MICT and Control increased CRF by 12.7 ml/kg/min, 5.6 ml/kg/min and 1.4 ml/kg/min, respectively, with a baseline pooled standard deviation of 9.8 (f = 0.49). Therefore, 45 participants (15 per group) were required to have 80% power to detect the difference
between groups using a one-way analysis of variance with a = 0.05. Fifty participants
would be required based on the average dropout rate of 10% for studies included in
Wewege et al. (2018).

Statistical analyses were performed in IBM SPSS Statistics version 24 (IBM Corp., Armonk, NY, USA) using an intention-to-treat analysis (baseline outcome carried forward for missing data). Asymmetric data (skewness value = -1 or = 1) were log-transformed if possible, to restore normal distribution. Data were expressed as mean and standard deviation, or median and range if asymmetric. Change from baseline was compared between groups with analysis of covariance (ANCOVA), using a priori covariates age, sex, and the baseline value, and an additional post-hoc covariate: whether the participant altered medication (Yes/No). Statistical significance was accepted at p < 0.05 with no multiplicity corrections.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
29/09/2017
Date of last participant enrolment
Anticipated
Actual
30/08/2018
Date of last data collection
Anticipated
Actual
26/10/2018
Sample size
Target
50
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 28437 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 304258 0
University
Name [1] 304258 0
UNSW Sydney
Country [1] 304258 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
The University of New South Wales
Sydney NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 304506 0
None
Name [1] 304506 0
Address [1] 304506 0
Country [1] 304506 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304713 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 304713 0
Ethics committee country [1] 304713 0
Australia
Date submitted for ethics approval [1] 304713 0
Approval date [1] 304713 0
14/08/2017
Ethics approval number [1] 304713 0
HREC17510

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

Contacts
Principal investigator
Name 97966 0
Dr Belinda Parmenter
Address 97966 0
School of Medical Sciences, Faculty of Medicine
The University of New South Wales
Sydney NSW 2052
Australia
Country 97966 0
Australia
Phone 97966 0
+61 2 9385 8313
Fax 97966 0
Email 97966 0
[email protected]
Contact person for public queries
Name 97967 0
Belinda Parmenter
Address 97967 0
School of Medical Sciences, Faculty of Medicine
The University of New South Wales
Sydney NSW 2052
Australia
Country 97967 0
Australia
Phone 97967 0
+61 2 9385 8313
Fax 97967 0
Email 97967 0
[email protected]
Contact person for scientific queries
Name 97968 0
Belinda Parmenter
Address 97968 0
School of Medical Sciences, Faculty of Medicine
The University of New South Wales
Sydney NSW 2052
Australia
Country 97968 0
Australia
Phone 97968 0
+61 2 9385 8313
Fax 97968 0
Email 97968 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.