ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Overweight and Obesity

Condition category

Condition code

Diet and Nutrition

Obesity

Musculoskeletal

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]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

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]

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]

Baseline, at 7 weeks and 10 weeks after commencement of the intervention.

Secondary outcome [1]

(PRIMARY OUTCOME)
Changes in blood glucose regulation obtained from venous blood samples by oral glucose tolerance test.

Timepoint [1]

Baseline, at 7 weeks and 10 weeks after commencement of the intervention.

Secondary outcome [2]

(PRIMARY OUTCOME)
Changes in resting metabolic rate by indirect calorimetry.

Timepoint [2]

Baseline, at 7 weeks and 10 weeks after commencement of the intervention.

Secondary outcome [3]

(PRIMARY OUTCOME)
Changes in body composition by dual-energy x-ray absorptiometry.

Timepoint [3]

Baseline, at 7 weeks and 10 weeks after commencement of the intervention.

Secondary outcome [4]

(PRIMARY OUTCOME)
Aerobic capacity by VO2 max testing.

Timepoint [4]

Baseline, at 4 weeks, 7 weeks and 10 weeks after commencement of the intervention.

Secondary outcome [5]

(PRIMARY OUTCOME)
Maximal strength by 1 repetition maximum testing.

Timepoint [5]

Baseline, at 4 weeks, 7 weeks and 10 weeks after commencement of the intervention.

Secondary outcome [6]

(PRIMARY OUTCOME)
Physical activity monitoring by accelerometry and inclinometry.

Timepoint [6]

Baseline, at weeks 1, 4, and 7-10 after commencement of the intervention.

Secondary outcome [7]

(COMPOSITE PRIMARY OUTCOME)
Changes in mood, behaviour and attitude towards physical activity by cognitive testing (i.e. visual analog scale)

Timepoint [7]

Baseline, at 7 weeks and 10 weeks after commencement of the intervention.

Secondary outcome [8]

Changes in satellite cell activity obtained from muscle biopsy by immunohistochemsitry.

Timepoint [8]

Baseline, at 7 weeks and 10 weeks after commencement of the intervention.

Secondary outcome [9]

Changes in whole muscle transcriptome, obtained by muscle biopsy and assessed by microarray analysis.

Timepoint [9]

Baseline, at 7 weeks and 10 weeks after commencement of the intervention.

Secondary outcome [10]

Changes in muscle architecture (muscle thickness, fascicle length, pennantion angle) by 2D ultrasound.

Timepoint [10]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3065 - Fitzroy

Funding & Sponsors

Funding source category [1]

University

Name [1]

Australian Catholic University

Address [1]

115 Victoria Parade, Fitzroy VIC 3065

Country [1]

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]

Individual

Name [1]

Professor John Hawley

Address [1]

Level 5
215 Spring St, Melbourne VIC 3000
Mary MacKillop Institute for Health Research

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Australian Catholic University Human Resarch Ethics Committee

Ethics committee address [1]

Australian Catholic University
North Sydney Campus
NORTH SYDNEY, NSW 2059

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/05/2017

Approval date [1]

15/06/2017

Ethics approval number [1]

2017-104H

Summary

Brief summary

High-intensity interval training (HIIT) is becoming more widely recognized as a time-efficient alternative to traditional endurance exercise for improving markers of cardiopulmonary and metabolic health. A major benefit of HIIT is the time-efficiency of a single exercise session which can be completed in under 30 minutes. HIIT involves short, repeated periods of work at or above maximal aerobic capacity interspersed with rest intervals (e.g. 1 min work, 1 min rest repeated 10 times). Given that HIIT requires rapid contraction of type 2 skeletal muscle fibres, as seen with resistance exercise, it is possible that HIIT may also be able to precipitate muscle mass gains. Whether HIIT with protein supplementation can facilitate similar skeletal muscle adaptations reported following resistance exercise, such as hypertrophy, remains understudied in the literature. When an individual stops training (i.e. detraining), loss of adaptation from exercise can occur. However, no study to date has investigated the effects of a short-term (i.e. 2½ weeks) detraining period on measures of strength and aerobic fitness between resistance, endurance and HIIT training.     

The purpose of this study is to investigate the metabolic and anabolic effects of 6 weeks of HIIT with protein supplementation on measures of muscle cross sectional area, body composition, resting metabolic rate, blood glucose control, muscle architecture, maximal strength and aerobic capacity in overweight and obese adults. 

Study aims:
1. Compare the anabolic/muscle growth effects of six weeks of HIIT with protein supplementation vs resistance exercise with protein supplementation
2. Compare the metabolic effects of six weeks of HIIT with protein supplementation vs endurance exercise with protein supplementation
3. Investigate the metabolic and anabolic effects of a 2½-week detraining period following each of the exercise interventions

Study hypotheses:
1. HIIT with protein supplementation will induce comparable increases in muscle fibre cross-sectional area, lean body mass, whole muscle transcriptome responses, muscle architecture, compared to resistance exercise with protein supplementation
2. HIIT with protein supplementation will induce comparable increases in insulin sensitivity, resting metabolic rate and mitochondrial protein content compared to endurance exercise with protein supplementation
3. Following a 2½-week detraining period, HIIT with protein supplementation will result in comparable losses in muscle cross sectional area, lean body mass, muscle thickness and muscle transcriptome responses compared to resistance exercise with protein supplementation
4. Following a 2½-week detraining period, greater losses in muscle cross sectional area, lean body mass, muscle thickness and muscle transcriptome responses will occur with endurance compared to HIIT exercise

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

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

Phone

+61392145233

Fax

dcamera@swin.edu.au

Contact person for public queries

Name

Donny Camera

Address

Department of Health and Medical Sciences,
Swinburne University
Room SPW224
Mail H21
PO Box 218 Hawthorn
Vic, 3122

Country

Australia

Phone

+61392145233

Fax

dcamera@swin.edu.au

Contact person for scientific queries

Name

Donny Camera

Address

Department of Health and Medical Sciences,
Swinburne University
Room SPW224
Mail H21
PO Box 218 Hawthorn
Vic, 3122

Country

Australia

Phone

+61392145233

Fax

dcamera@swin.edu.au

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 dcamera@swin.edu.au. 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.	Type	Email
9685	Study protocol	Marcus.callahan@myacu.edu.au
9686	Statistical analysis plan	Marcus.callahan@myacu.edu.au
9687	Informed consent form	Marcus.callahan@myacu.edu.au
9688	Clinical study report	Marcus.callahan@myacu.edu.au
9689	Ethical approval	Marcus.callahan@myacu.edu.au
9690	Analytic code	Marcus.callahan@myacu.edu.au

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically