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Trial registered on ANZCTR


Registration number
ACTRN12618001778279p
Ethics application status
Not yet submitted
Date submitted
25/10/2018
Date registered
30/10/2018
Date last updated
30/10/2018
Date data sharing statement initially provided
30/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
High-intensity interval training to counteract the age-related loss of muscle mass in middle-aged adults.
Scientific title
High intensity aerobic and resistance interval training to counteract pro-dromal sarcopenia and sarcopenic-obesity in middle-aged adults.
Secondary ID [1] 296403 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pro-dromal sarcopenia 310154 0
Pro-dromal sarcopenic-obesity 310155 0
Condition category
Condition code
Musculoskeletal 308906 308906 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 308949 308949 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention includes a 40-week randomized controlled trial of high intensity aerobic and resistance interval training (HIART). The 40-week intervention involves 20 weeks of training followed by a 20-week follow-up. Each training session will start with a warming up, then the HIART training and ends with a cool-down. The HIART training involves three phases, set up as a circuit. The three phases are;
1) a “power” phase, consisting of three whole-body resistance exercises (e.g. jumping jacks, lunges, push-ups, squats)
2) 10 minutes of high-intensity cardiorespiratory cycling
3) 3 sets of 3 free weight exercises, with appropriate rest between each phase (e.g. biceps curl, weighted lunges, weighted squats).
Training load will be self-selected from designated options but participants will be encouraged to choose a wattage that will ensure that their heart rate reaches 85% of their maximum heart rate during the high-intensity peaks and does not drop below 60% of their maximum heart rate during the low-intensity periods.
All training sessions are group-based, with a maximum of 10 people in each group. All training sessions will be provided by a trained and experienced physiotherapist.
In order to maximize adherence, participants will receive an appointment card every first session of the week and they will receive a text message 24 hours before the exercise session. Adherence will be monitored using attendance checklists by the physiotherapist.
Intervention code [1] 312734 0
Prevention
Intervention code [2] 312754 0
Lifestyle
Comparator / control treatment
The control group will receive education on current exercise recommendations during a 60-minute group-session, provided by a physiotherapist. Current exercises recommendations will be defined as proposed by the WHO (Adults aged 18–64 should do at least 150 minutes of moderate-intensity aerobic physical activity throughout the week or do at least 75 minutes of vigorous-intensity aerobic physical activity throughout the week or an equivalent combination of moderate- and vigorous-intensity activity; http://www.who.int/dietphysicalactivity/factsheet_adults/en/). Following the 40-week follow-up, they will then be offered two weeks of supervised exercise sessions, where they are taught how to perform HIART. At the end of the two weeks, they will be given a training CD to complete sessions at home. The training CD will be specifically designed for this study.
Control group
Active

Outcomes
Primary outcome [1] 307894 0
Muscle mass will be assessed with Dual-energy X-ray absorptiometry (DXA) and analysed using DXA software (Lunar Prodigy, GE Medical Systems, Madison, WI).
Timepoint [1] 307894 0
Baseline (1 week before start intervention)
Post-intervention (20 weeks post-intervention commencement)
Long-term follow-up (40 weeks post-intervention commencement)
Secondary outcome [1] 353253 0
Physical activity (steps/day) will be measured by using an accelerometer attached to a waist strap (Actigraph GT3X+, Pensacola, FL, USA).
Timepoint [1] 353253 0
Baseline (1 week before start intervention)
Long-term follow-up (40 weeks post-intervention commencement)
Secondary outcome [2] 353254 0
Grip strength will be measured using the JAMAR Handheld Dynamometer.
Timepoint [2] 353254 0
Baseline (1 week before start intervention)
Interim-intervention (10 weeks after intervention commencement)
Post-intervention (20 weeks post-intervention commencement)
Long-term follow-up (40 weeks post-intervention commencement)
Secondary outcome [3] 353304 0
Aerobic endurance will be measured using a VO2max cycle test.
Timepoint [3] 353304 0
Baseline (1 week before start intervention)
Interim-intervention (10 weeks after intervention commencement)
Post-intervention (20 weeks post-intervention commencement)
Long-term follow-up (40 weeks post-intervention commencement)
Secondary outcome [4] 353305 0
A 3RM-test will be performed to measure strength of the upper extremities with a biceps curl.
Timepoint [4] 353305 0
Baseline (1 week before start intervention)
Interim-intervention (10 weeks after intervention commencement)
Post-intervention (20 weeks post-intervention commencement)
Long-term follow-up (40 weeks post-intervention commencement)
Secondary outcome [5] 353306 0
Gait speed will be measured with the four-meter gait speed test.
Timepoint [5] 353306 0
Baseline (1 week before start intervention)
Interim-intervention (10 weeks after intervention commencement)
Post-intervention (20 weeks post-intervention commencement)
Long-term follow-up (40 weeks post-intervention commencement)
Secondary outcome [6] 353307 0
Lower extremity strength and endurance will be measured with the 30 Seconds Sit to Stand Test.
Timepoint [6] 353307 0
Baseline (1 week before start intervention)
Interim-intervention (10 weeks after intervention commencement)
Post-intervention (20 weeks post-intervention commencement)
Long-term follow-up (40 weeks post-intervention commencement)
Secondary outcome [7] 353308 0
Isokinetic strength of the knee-extensor (m. quadriceps) will be measured using Biodex (Biodex Corporation, Shirley, NY, USA).
Timepoint [7] 353308 0
Baseline (1 week before start intervention)
Interim-intervention (10 weeks after intervention commencement)
Post-intervention (20 weeks post-intervention commencement)
Long-term follow-up (40 weeks post-intervention commencement)
Secondary outcome [8] 353309 0
To measure the perceived enjoyment of physical activity, the 18-item Physical Activity Enjoyment Scale (PACES) will be completed.
Timepoint [8] 353309 0
Baseline (1 week before start intervention)
Interim-intervention (10 weeks after intervention commencement)
Post-intervention (20 weeks post-intervention commencement)
Long-term follow-up (40 weeks post-intervention commencement)
Secondary outcome [9] 353310 0
To measure the self-efficacy of physical activity, the 18-item Exercise Self-Efficacy scale (ESES) will be completed.
Timepoint [9] 353310 0
Baseline (1 week before start intervention)
Interim-intervention (10 weeks after intervention commencement)
Post-intervention (20 weeks post-intervention commencement)
Long-term follow-up (40 weeks post-intervention commencement)
Secondary outcome [10] 353311 0
To measure health status, Short Form 12 Health Survey (SF-12) will be completed.
Timepoint [10] 353311 0
Baseline (1 week before start intervention)
Interim-intervention (10 weeks after intervention commencement)
Post-intervention (20 weeks post-intervention commencement)
Long-term follow-up (40 weeks post-intervention commencement)
Secondary outcome [11] 353362 0
A 3RM-test will be performed to measure the strength of the lower extremities, with a leg press.
Timepoint [11] 353362 0
Baseline (1 week before start intervention)
Interim-intervention (10 weeks after intervention commencement)
Post-intervention (20 weeks post-intervention commencement)
Long-term follow-up (40 weeks post-intervention commencement)
Secondary outcome [12] 353363 0
Isometric strength of the knee-extensor (m. quadriceps) will be measured using Biodex (Biodex Corporation, Shirley, NY, USA).
Timepoint [12] 353363 0
Baseline (1 week before start intervention)
Interim-intervention (10 weeks after intervention commencement)
Post-intervention (20 weeks post-intervention commencement)
Long-term follow-up (40 weeks post-intervention commencement)

Eligibility
Key inclusion criteria
Inclusion criteria will include otherwise healthy men and women aged between 40 and 50 years of age, who are not meeting the physical activity guidelines (2.5 hours a week of moderate activity) and are at risk of developing low muscle mass. Being at risk of developing low muscle mass will be assessed using a newly developed screening tool.
Minimum age
40 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they:
1) Take medications known to affect body composition or heart rate;
2) Are diagnosed with moderate or severe hypertension;
3) Are pregnant or breastfeeding, or planning on becoming pregnant during the intervention;
4) Have a previous diagnosis or symptoms of cardiovascular disease or other serious medical condition;
5) Screened out after exercise safety screening;
6) Weigh more than 159.9 kg (weight limit of the DXA scanner);
7) Live outside of metropolitan Dunedin;
8) Are unable to communicate in English or te reo Maori.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 20953 0
New Zealand
State/province [1] 20953 0
Otago

Funding & Sponsors
Funding source category [1] 301011 0
University
Name [1] 301011 0
University of Otago Research Grant
Address [1] 301011 0
362 Leith Street,
Dunedin 9016.
Country [1] 301011 0
New Zealand
Funding source category [2] 301028 0
University
Name [2] 301028 0
Dean's Bequest Dunedin School of Medicine
Address [2] 301028 0
201 Great King Street
Dunedin 9016
Country [2] 301028 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
362 Leith Street,
Dunedin 9016.
Country
New Zealand
Secondary sponsor category [1] 300615 0
None
Name [1] 300615 0
Address [1] 300615 0
Country [1] 300615 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 301769 0
The University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 301769 0
Ground Floor Clocktower Building
Leith St,
Dunedin, 9016
Ethics committee country [1] 301769 0
New Zealand
Date submitted for ethics approval [1] 301769 0
12/11/2018
Approval date [1] 301769 0
Ethics approval number [1] 301769 0

Summary
Brief summary
Sarcopenia is the age-related loss of skeletal muscle mass and strength. The combined loss of muscle with excess adiposity is called sarcopenic-obesity. The focus of these conditions has been in those over 60 years of age. However, the progressive loss of skeletal muscle mass and strength begins in middle age, when obesity also peaks. Therefore, the aim of this research is to assess the effects of a high-intensity exercise to reverse early onset (pro-dromal) sarcopenia and sarcopenic-obesity in early middle age.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88038 0
Dr Kim Meredith-Jones
Address 88038 0
Department of Medicine, University of Otago
201 Great King Street,
Dunedin 9016
Otago, New Zealand
Country 88038 0
New Zealand
Phone 88038 0
+64 3 470 9126
Fax 88038 0
Email 88038 0
kim.meredith-jones@otago.ac.nz
Contact person for public queries
Name 88039 0
Dr Kim Meredith-Jones
Address 88039 0
Department of Medicine, University of Otago
201 Great King Street,
Dunedin 9016
Otago, New Zealand
Country 88039 0
New Zealand
Phone 88039 0
+64 3 470 9126
Fax 88039 0
Email 88039 0
kim.meredith-jones@otago.ac.nz
Contact person for scientific queries
Name 88040 0
Dr Kim Meredith-Jones
Address 88040 0
Department of Medicine, University of Otago
201 Great King Street,
Dunedin 9016
Otago, New Zealand
Country 88040 0
New Zealand
Phone 88040 0
+64 3 470 9126
Fax 88040 0
Email 88040 0
kim.meredith-jones@otago.ac.nz

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 other documents available
Summary results
Not applicable