Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001095459
Ethics application status
Approved
Date submitted
9/08/2016
Date registered
12/08/2016
Date last updated
29/11/2018
Date data sharing statement initially provided
29/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating response to exercise programs in monozygotic and dizygotic twins to determine whether exercise response is generic, genetic or modality dependent.
Scientific title
Towards Exercise as Personalised Medicine: Is Non-Response to Exercise Generic, Genetic or Modality Dependent?
Secondary ID [1] 289821 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular health responses to exercise modalities in apparently healthy subjects 299747 0
Condition category
Condition code
Cardiovascular 299679 299679 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twin pairs will be randomised to simultaneously undertake 36 sessions of 3 sessions per week of either resistance or endurance training. This will be followed by a 12 week washout period. Each twin pair will then cross-over to start a similar period of training with the alternate intervention.

Each exercise session will last for 1 hr and be group, centre-based and supervised by and exercise scientist at the UWA Sport Science research gym. Adherance will be monitored by registering attendance at each session. The resistance training will consist of weighted exercises at an intensity according to RPE (>14/20) and endurance training will consist of running and cycle ergometer at intensity according to HR max (60%+).
Intervention code [1] 295497 0
Treatment: Other
Comparator / control treatment
Two exercise programs (endurance and resistance) exercise will be randomised and compared.
Control group
Active

Outcomes
Primary outcome [1] 299141 0
Conduit artery function: Brachial and femoral artery flow mediated dilation (FMD) will be assessed according to best practice guidelines. A cuff is inflated (220mmHg) around the forearm and upper thigh for 5min to induce ischaemic conditions whilst high resolution ultrasound of the brachial and femoral artery are obtained pre-post- artery occlusion. The FMD% increase in artery dilation is an indicator of artery function and independently predicts CV events. Endothelium independent dilation is examined using a single, subligual administration of glyceryl trinitrate.
Timepoint [1] 299141 0
Weeks:
0 (pre-training intervention 1),
12 (post-training intervention 1),
24 (post-washout period and pre-training intervention 1), and
36 (post-training intervention 2).
Primary outcome [2] 299142 0
Intracranial blood velocity: Cerebral blood flow velocity (CBFv) is assessed by combining bilateral measures of middle (MCA) and posterior cerebral artery (PCA) flow velocities using transcranial Doppler (TCD) techniques.
Timepoint [2] 299142 0
Weeks:
0 (pre-training intervention 1),
12 (post-training intervention 1),
24 (post-washout period and pre-training intervention 1), and
36 (post-training intervention 2).
Primary outcome [3] 299143 0
Cardiac outcome measures: Echocardiographic images will be acquired using a 1.5-4MHz transducer (Vivid I, GE). Left ventricular stress, strain and mechanics will be assessed using echopac.
Timepoint [3] 299143 0
Weeks:
0 (pre-training intervention 1),
12 (post-training intervention 1),
24 (post-washout period and pre-training intervention 1), and
36 (post-training intervention 2).
Secondary outcome [1] 326308 0
Fitness will be assessed via common practice of a maximal graded treadmill running test that will determine VO2peak. This will be accompanied by common practice blood lactates, heart rate (via chest-worn HR monitor) and rate of perceived exertion (via Borgs scale; composite outcomes) during every stage of the test.
Timepoint [1] 326308 0
Weeks:
0 (pre-training intervention 1),
12 (post-training intervention 1),
24 (post-washout period and pre-training intervention 1), and
36 (post-training intervention 2).
Secondary outcome [2] 326630 0
Fitness will also be assessed via common practice of strength (1RM) testing, of the maximum load that can be moved by the participant in one muscular contraction of the squat and bench press machine exercises.
Timepoint [2] 326630 0
Weeks:
0 (pre-training intervention 1),
12 (post-training intervention 1),
24 (post-washout period and pre-training intervention 1), and
36 (post-training intervention 2).
Secondary outcome [3] 326631 0
A resting blood pressure will be assessed every 2 minutes for 20minutes in a supine position. This will be in a controlled environment free from distraction and temperature/light controlled.
Timepoint [3] 326631 0
Weeks:
0 (pre-training intervention 1),
12 (post-training intervention 1),
24 (post-washout period and pre-training intervention 1), and
36 (post-training intervention 2).
Secondary outcome [4] 326632 0
Body composition will be assessed by girths of common sites (hips, wait, arm), BMI and DEXA.
Timepoint [4] 326632 0
Weeks:
0 (pre-training intervention 1),
12 (post-training intervention 1),
24 (post-washout period and pre-training intervention 1), and
36 (post-training intervention 2).

Eligibility
Key inclusion criteria
Healthy twin pairs aged 15-40yrs will be recruited. We will recruit twin pairs via advertisement in the Perth metropolitan area via flyers. Additionally, we have approval from the Australian Twin Registry (ATR) to use their database.
Minimum age
15 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
>4 units alcohol/day, medical conditions that compromise survival (i.e. cancer) or render subjects unable to exercise, BMI>35, history of myocardial infarction, coronary artery disease, stroke, chronic heart failure, diabetes. Cardiovascular medications or supplements that affect cardiovascular function will also constitute exclusions. Twins completing >150mins/wk of exercise will be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Twin study design of MZ and DZ (sex matched) twin pairs
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/08/2016
Actual
10/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
70
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 294205 0
University
Name [1] 294205 0
The University of Western Ausralia
Country [1] 294205 0
Australia
Primary sponsor type
Individual
Name
Winthrop Professor Daniel Green
Address
The University of Western Australia, 35 Stirling Highway, Crawley, WA, 6009
Country
Australia
Secondary sponsor category [1] 293101 0
None
Name [1] 293101 0
Address [1] 293101 0
Country [1] 293101 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295613 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 295613 0
The University of Western Australia, 35 Stirling Highway, Crawley, WA, 6009
Ethics committee country [1] 295613 0
Australia
Date submitted for ethics approval [1] 295613 0
Approval date [1] 295613 0
10/05/2016
Ethics approval number [1] 295613 0
RA/4/1/7031

Summary
Brief summary
There has never been a more sedentary population than the 21st century western society, with physical inactivity accounting for a similar number of deaths per annum as tobacco. Physical inactivity is a modifiable risk factor for chronic disease, especially cardiovascular diseases, and no other intervention possesses the broad spectrum of health impacts that can be attributed to exercise. However, the cardiovascular response of an individual to exercise is idiosyncratic and, whilst most individuals incur favourable effects, a sizeable proportion (~30%) of individuals either do not respond or respond “adversely” to exercise. The current research study aims to answer two fundamental questions. Firstly, is non-response to one exercise modality universal across all modalities? Secondly, to what extent is non-response to exercise environmentally versus genetically determined?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67946 0
Prof Daniel J Green
Address 67946 0
The University of Western Australia, 35 Stirling Highway, Crawley, WA, 6009
Country 67946 0
Australia
Phone 67946 0
+61 8 64882361
Fax 67946 0
Email 67946 0
[email protected]
Contact person for public queries
Name 67947 0
Miss Channa Marsh
Address 67947 0
The University of Western Australia, 35 Stirling Highway, Crawley, WA, 6009
Country 67947 0
Australia
Phone 67947 0
+61 8 64882361
Fax 67947 0
Email 67947 0
[email protected]
Contact person for scientific queries
Name 67948 0
Prof Daniel Green
Address 67948 0
The University of Western Australia, 35 Stirling Highway, Crawley, WA, 6009
Country 67948 0
Australia
Phone 67948 0
+61 8 6488 5609
Fax 67948 0
Email 67948 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Individual participant data will be available upon request by peer-reviewers.


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
SourceTitleYear of PublicationDOI
EmbaseResistance, but not endurance exercise training, induces changes in cerebrovascular function in healthy young subjects.2021https://dx.doi.org/10.1152/ajpheart.00230.2021
EmbaseExploring human trainability: Design and rationale of Studies of Twin Responses to Understand Exercise as a Therapy (STRUETH) study.2020https://dx.doi.org/10.1016/j.conctc.2020.100584
EmbaseExercise and Artery Function in Twins: Sex Differences in a Cross-Over Trial.2023https://dx.doi.org/10.1161/HYPERTENSIONAHA.123.21090
EmbaseSex differences in cardiovascular risk factor responses to resistance and endurance training in younger subjects.2023https://dx.doi.org/10.1152/ajpheart.00482.2022
EmbaseStudies of Twin Responses to Understand Exercise THerapy (STRUETH): cerebrovascular function.2022https://dx.doi.org/10.1113/JP282998
EmbaseEndurance versus resistance training in treatment of cardiovascular risk factors: A randomized cross-over trial.2022https://dx.doi.org/10.1371/journal.pone.0274082
N.B. These documents automatically identified may not have been verified by the study sponsor.