Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000894392
Ethics application status
Approved
Date submitted
14/06/2017
Date registered
19/06/2017
Date last updated
10/11/2020
Date data sharing statement initially provided
10/11/2020
Date results provided
10/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of resistance, endurance and high intensity interval training in middle-aged overweight and obese men.
Scientific title
Metabolic and anabolic effects of resistance, endurance and high intensity interval training in middle-aged overweight and obese men and the subsequent effects of detraining.
Secondary ID [1] 292198 0
Nil known.
Universal Trial Number (UTN)
U1111-1197-9525
Trial acronym
REHIIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia 303678 0
Overweight and Obesity 303679 0
Condition category
Condition code
Diet and Nutrition 303058 303058 0 0
Obesity
Musculoskeletal 303065 303065 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name:
The metabolic and anabolic effects of 6 weeks of resistance (REX), endurance (END) and high intensity interval training (HIIT) with protein supplementation and the subsequent effects of 2.5 weeks of detraining.

Materials:
All people who wish to participate in the study will be provided with a copy of the Letter to Participants and a letter to their GP. Clearance from a GP is necessary as participants will perform maximal exercise testing. All participants will be provided with a copy of the signed study consent form.

Procedures:
Participants will be asked to record their diet using a phone App to meet individual energy and protein (1.3-1.5 g/kg) targets as estimated from the baseline resting metabolic rate test. To assist with diet recording compliance, participants will be provided with a document stating their targets and will receive ongoing feedback in person once every 3 weeks from the study dietitian to ensure they are consuming enough food to assist with expected responses (e.g. increased lean mass) following the exercise interventions. One-on-one diet consults throughout the study will run for 15-20 min each. Participants will also receive high protein supplements (e.g. protein powder, yoghurt, energy bars) to improve adherence to the dietary protocol. On training days, participants will consume a protein shake containing 25-30 g of whey protein following all exercise sessions. On all days of the study, participants will be instructed to spread their protein intake across the day. Further, participants will be instructed not to drink alcohol on training days and restrict alcohol intake to two standard drinks on all days of the study.

All exercise groups described will complete 3 sessions per week for 6 weeks with at least 1 day of recovery separating each session. Exercise sessions will be administered one-on-one or in small groups (2-3 people) depending on the time that each participants chooses to train. To monitor participation adherence, a register of attendance will be completed at every session and participants will be provided with electronic appointments to avoid scheduling conflicts. Participants will be stratified to one of the exercise interventions by lean muscle mass determined from the baseline body composition (DXA) scan. The principal investigator will be responsible for stratification. As the primary outcome of the study is change in muscle cross sectional area, similar baseline muscle masses between each of the groups is essential to avoid biased results post intervention.

HIIT: After warming up at a light intensity for 3 minutes on an exercise bike, participants will perform 10 x 1 min cycling work efforts at 90% of peak power output (PPO) separated by 1 min recovery at 30 W. To finish the session, you will complete a light warm down for 3 min. The efforts will be increased in intensity progressively throughout the program. All exercise sessions will be take place in an exercise physiology laboratory supervised by a qualified exercise scientist.

Detraining: No structured exercise will be allowed for 2.5 weeks following the exercise programs.
Intervention code [1] 298355 0
Prevention
Intervention code [2] 298356 0
Lifestyle
Intervention code [3] 298361 0
Treatment: Other
Comparator / control treatment
REX and END groups will receive identical protein supplementation and dietary support to that of the HIIT group.

REX: The resistance exercise protocol will consist of a whole-body routine using machines and free weights. Exercises will be started at 60-65% of 1 repetition maximum (1RM) at rep ranges of 9-12 to elicit RPE scores of 8-10 (with 10 being maximum effort). Resistance exercise will progressively increase in weight to account for increases in muscle size and strength throughout the program. By week 3 of the program, participants will lift loads at 70-75% of 1RM with rep ranges and predicted RPE scores remaining the same. Mid intervention 1RM testing will take place at the start of week 4 to establish new training loads for the remaining 3 weeks of the intervention. Following week 4 1RM testing, participants will continue to lift loads at 70-77.5% of 1RM with rep ranges and predicted RPE scores remaining the same. All exercise sessions will be take place in a gymnasium supervised by a qualified exercise scientist.

END: Training will vary in intensity and duration however intensities will range between 50-65% of VO2 max and duration between 30-60 min. All exercise will be performed on an exercise bike. All exercise sessions will be take place in an exercise physiology laboratory supervised by a qualified exercise scientist.
Control group
Active

Outcomes
Primary outcome [1] 302437 0
Changes in muscle fibre cross-sectional area (Type I and II) obtained by muscle biopsy and measured by immunohistochemistry following each of the exercise interventions.
Timepoint [1] 302437 0
Baseline, at 7 weeks and 10 weeks after commencement of the intervention.
Secondary outcome [1] 336004 0
(PRIMARY OUTCOME)
Changes in blood glucose regulation obtained from venous blood samples by oral glucose tolerance test.
Timepoint [1] 336004 0
Baseline, at 7 weeks and 10 weeks after commencement of the intervention.
Secondary outcome [2] 336031 0
(PRIMARY OUTCOME)
Changes in resting metabolic rate by indirect calorimetry.
Timepoint [2] 336031 0
Baseline, at 7 weeks and 10 weeks after commencement of the intervention.
Secondary outcome [3] 336036 0
(PRIMARY OUTCOME)
Changes in body composition by dual-energy x-ray absorptiometry.
Timepoint [3] 336036 0
Baseline, at 7 weeks and 10 weeks after commencement of the intervention.
Secondary outcome [4] 336039 0
(PRIMARY OUTCOME)
Aerobic capacity by VO2 max testing.
Timepoint [4] 336039 0
Baseline, at 4 weeks, 7 weeks and 10 weeks after commencement of the intervention.
Secondary outcome [5] 336041 0
(PRIMARY OUTCOME)
Maximal strength by 1 repetition maximum testing.
Timepoint [5] 336041 0
Baseline, at 4 weeks, 7 weeks and 10 weeks after commencement of the intervention.
Secondary outcome [6] 336046 0
(PRIMARY OUTCOME)
Physical activity monitoring by accelerometry and inclinometry.
Timepoint [6] 336046 0
Baseline, at weeks 1, 4, and 7-10 after commencement of the intervention.
Secondary outcome [7] 336048 0
(COMPOSITE PRIMARY OUTCOME)
Changes in mood, behaviour and attitude towards physical activity by cognitive testing (i.e. visual analog scale)
Timepoint [7] 336048 0
Baseline, at 7 weeks and 10 weeks after commencement of the intervention.
Secondary outcome [8] 336049 0
Changes in satellite cell activity obtained from muscle biopsy by immunohistochemsitry.
Timepoint [8] 336049 0
Baseline, at 7 weeks and 10 weeks after commencement of the intervention.
Secondary outcome [9] 388740 0
Changes in whole muscle transcriptome, obtained by muscle biopsy and assessed by microarray analysis.
Timepoint [9] 388740 0
Baseline, at 7 weeks and 10 weeks after commencement of the intervention.
Secondary outcome [10] 388741 0
Changes in muscle architecture (muscle thickness, fascicle length, pennantion angle) by 2D ultrasound.
Timepoint [10] 388741 0
Baseline, at 7 weeks and 10 weeks after commencement of the intervention.

Eligibility
Key inclusion criteria
Overweight or obese (BMI 25-35)
Sedentary - less than 150 min of moderate intensity physical activity or 75 min of vigorous intensity physical activity per week.
No type 2 diabetes
Pass the Exercise and Sports Science Australia pre-exercise screening tool and obtain GP clearance to exercise
No injuries preventing exercise
Minimum age
35 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Identified as high risk by GP despite passing all other inclusion criteria
Currently losing weight
Smoker
Participation in structured exercise in the past 6 months
Not willing to use phone App to record diet
Had bariatric surgery in the past
Vegan
Hormone replacement therapy
Shift worker

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/06/2017
Actual
27/06/2017
Date of last participant enrolment
Anticipated
8/02/2018
Actual
11/05/2018
Date of last data collection
Anticipated
30/04/2018
Actual
5/06/2018
Sample size
Target
36
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 16445 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 296734 0
University
Name [1] 296734 0
Australian Catholic University
Country [1] 296734 0
Australia
Primary sponsor type
Individual
Name
Dr Donny Camera
Address
Department of Health and Medical Sciences,
Swinburne University
Room SPW224
Mail H21
PO Box 218 Hawthorn
Vic, 3122
Country
Australia
Secondary sponsor category [1] 295705 0
Individual
Name [1] 295705 0
Professor John Hawley
Address [1] 295705 0
Level 5
215 Spring St, Melbourne VIC 3000
Mary MacKillop Institute for Health Research
Country [1] 295705 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297963 0
Australian Catholic University Human Resarch Ethics Committee
Ethics committee address [1] 297963 0
Ethics committee country [1] 297963 0
Australia
Date submitted for ethics approval [1] 297963 0
11/05/2017
Approval date [1] 297963 0
15/06/2017
Ethics approval number [1] 297963 0
2017-104H

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

Contacts
Principal investigator
Name 75594 0
Dr Donny Camera
Address 75594 0
Department of Health and Medical Sciences,
Swinburne University
Room SPW224
Mail H21
PO Box 218 Hawthorn
Vic, 3122
Country 75594 0
Australia
Phone 75594 0
+61392145233
Fax 75594 0
Email 75594 0
[email protected]
Contact person for public queries
Name 75595 0
Donny Camera
Address 75595 0
Department of Health and Medical Sciences,
Swinburne University
Room SPW224
Mail H21
PO Box 218 Hawthorn
Vic, 3122
Country 75595 0
Australia
Phone 75595 0
+61392145233
Fax 75595 0
Email 75595 0
[email protected]
Contact person for scientific queries
Name 75596 0
Donny Camera
Address 75596 0
Department of Health and Medical Sciences,
Swinburne University
Room SPW224
Mail H21
PO Box 218 Hawthorn
Vic, 3122
Country 75596 0
Australia
Phone 75596 0
+61392145233
Fax 75596 0
Email 75596 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following article publication.
Available to whom?
Researchers who provide a methodologically sound proposal.
Available for what types of analyses?
To achieve aims in the approved proposal.
How or where can data be obtained?
Proposals should be directed to [email protected]. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be included).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9685Study protocol  [email protected]
9686Statistical analysis plan  [email protected]
9687Informed consent form  [email protected]
9688Clinical study report  [email protected]
9689Ethical approval  [email protected]
9690Analytic code  [email protected]



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.