Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001546842
Ethics application status
Approved
Date submitted
23/09/2021
Date registered
12/11/2021
Date last updated
10/12/2023
Date data sharing statement initially provided
12/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The influence of a single bout of low compared to moderate-intensity exercise on white blood cell telomerase activity in young and older adults: The Telomerase Activity after LOw and Moderate Intensity Exercise (TALOMIE) trial
Scientific title
The Telomerase Activity after LOw and Moderate Intensity Exercise (TALOMIE) trial in young (18-45 years) and older (65-80 years) healthy adults
Secondary ID [1] 305153 0
None
Universal Trial Number (UTN)
U1111-1271-5487
Trial acronym
TALOMIE
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 323415 0
Type 2 diabetes 323416 0
Dementia 323417 0
Condition category
Condition code
Cardiovascular 320968 320968 0 0
Other cardiovascular diseases
Metabolic and Endocrine 321545 321545 0 0
Diabetes
Neurological 321546 321546 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised crossover trial with 2 intervention arms:
Arm 1: A single 30-min bout of low-intensity (55% of estimated functional threshold power [FTP]) aerobic exercise (stationary cycling)
Arm 2: A single 30-min bout of moderate-intensity (85% of estimated FTP) aerobic exercise (stationary cycling)

There will be a minimum of 3 days and a maximum of 7 days between trial arms. Prior to the trial arms, participants will complete an incremental test to exhaustion on a stationary cycle ergometer to assess their maximal aerobic fitness. Results from the incremental exercise test will be used to personalise the exercise intensity during the trial arms.

All session will be supervised (face-to-face) by an Accredited Exercise Scientist (AES) (with Exercise and Sports Science Australia [ESSA]) and they will provide verbal encouragement/support as appropriate. AESs are experts in exercise testing and training individuals who are apparently healthy, who hold a minimum of a Bachelor degree.

The study design will enable us to examine the influence of low versus moderate intensity exercise on hTERT gene expression and telomerase activity in humans. The exercises selected are typical training sessions that adhere to the National Physical Activity Guidelines.
Intervention code [1] 321559 0
Lifestyle
Comparator / control treatment
As we are interested in the influence of a single bout of low versus moderate intensity aerobic exercise on leukocyte telomerase activity and TERT gene expression, a genuine control group is not included. However, each individual will serve as their own control, since telomerase/TERT activity will be analysed using individuals' fold-difference from basal (before each exercise bout).
Control group
Active

Outcomes
Primary outcome [1] 328739 0
Peripheral blood mononuclear cell (PBMC) telomerase reverse transcriptase (TERT) gene expression will be quantified by quantitative PCR. Gene expression relative to the control gene, GAPDH, will be used in statistical analyses.
Timepoint [1] 328739 0
Basal (before each exercise bout), immediately after and 1 hour after the completion of each exercise bout (primary timepoint).
Primary outcome [2] 328887 0
PBMC telomerase activity quantified by TRAPeze RT Telomerase Detection Kit.
Timepoint [2] 328887 0
Basal (before each exercise bout), immediately after (primary timepoint) and 1 hour after the completion of each exercise bout.
Secondary outcome [1] 400216 0
Heart rate (beats per minute) recorded using a chest strap and Garmin GPS device.
Timepoint [1] 400216 0
Recorded as beats per minute throughout each bout of exercise.
Secondary outcome [2] 400217 0
PBMC ACD Shelterin Complex Subunit And Telomerase Recruitment Factor (ACD) relative gene expression analysis (expressed relative to the control gene, GAPDH) using a TaqMan Gene Assay.
Timepoint [2] 400217 0
Basal (before each exercise bout), immediately after and 1 hour after the completion of each exercise bout.
Secondary outcome [3] 400219 0
Rate of perceived exertion (RPE)
Timepoint [3] 400219 0
Assessed using the BORG RPE scale during incremental exercise testing, and at baseline, 15 minutes into the exercise bout and at the completion of the exercise bout.
Secondary outcome [4] 400968 0
Blood lactate measured by a hand held blood lactate analyser.
Timepoint [4] 400968 0
During incremental exercise testing, before, during (15 min into the exercise) and immediately after each bout of exercise.
Secondary outcome [5] 400970 0
Oxygen consumption (VO2) measured by pulmonary analysis.
Timepoint [5] 400970 0
Baseline - prior to exercise trials and continuously throughout each bout of exercise training.
Secondary outcome [6] 401018 0
Systolic blood pressure will be measured by the Human NIBP Nano System (AD Instruments) and assessed as a composite secondary outcome.
Timepoint [6] 401018 0
Baseline (before each bout of exercise), 15 minutes into the exercise trial, immediately after the exercise trial and 1 hour after the cessation of exercise.
Secondary outcome [7] 402092 0
PBMC Telomerase RNA component (TERC) relative gene expression analysis (expressed relative to the control gene, GAPDH) using a TaqMan Gene Assay.
Timepoint [7] 402092 0
Basal (before each exercise bout), immediately after and 1 hour after the completion of each exercise bout.
Secondary outcome [8] 402093 0
PBMC Nuclear respiratory factor 1 (NRF1) relative gene expression analysis (expressed relative to the control gene, GAPDH) using a TaqMan Gene Assay.
Timepoint [8] 402093 0
Basal (before each exercise bout), immediately after and 1 hour after the completion of each exercise bout.
Secondary outcome [9] 402094 0
PBMC Peroxisome Proliferator Activated Receptor Delta (PPARD) relative gene expression analysis (expressed relative to the control gene, GAPDH) using a TaqMan Gene Assay.
Timepoint [9] 402094 0
Basal (before each exercise bout), immediately after and 1 hour after the completion of each exercise bout.
Secondary outcome [10] 402095 0
PBMC Peroxisome Proliferator-Activated Receptor Gamma Coactivator 1-Alpha (PPARGC1A) relative gene expression analysis (expressed relative to the control gene, GAPDH) using a TaqMan Gene Assay.
Timepoint [10] 402095 0
Basal (before each exercise bout), immediately after and 1 hour after the completion of each exercise bout.
Secondary outcome [11] 402096 0
PBMC Transcription Factor A, Mitochondrial (TFAM) relative gene expression analysis (expressed relative to the control gene, GAPDH) using a TaqMan Gene Assay.
Timepoint [11] 402096 0
Basal (before each exercise bout), immediately after and 1 hour after the completion of each exercise bout.
Secondary outcome [12] 402097 0
Diastolic blood pressure will be measured by the Human NIBP Nano System (AD Instruments) and assessed as a composite secondary outcome.
Timepoint [12] 402097 0
Baseline (before each bout of exercise), 15 minutes into the exercise trial, immediately after the exercise trial and 1 hour after the cessation of exercise.
Secondary outcome [13] 402098 0
Mean arterial pressure will be measured by the Human NIBP Nano System (AD Instruments) and assessed as a composite secondary outcome.

Timepoint [13] 402098 0
Baseline (before each bout of exercise), 15 minutes into the exercise trial, immediately after the exercise trial and 1 hour after the cessation of exercise.
Secondary outcome [14] 402099 0
Estimated cardiac output will be measured by the Human NIBP Nano System (AD Instruments) and assessed as a composite secondary outcome..


Timepoint [14] 402099 0
Baseline (before each bout of exercise), 15 minutes into the exercise trial, immediately after the exercise trial and 1 hour after the cessation of exercise.
Secondary outcome [15] 402100 0
Stroke volume will be measured by the Human NIBP Nano System (AD Instruments) and assessed as a composite secondary outcome.

Timepoint [15] 402100 0
Baseline (before each bout of exercise), 15 minutes into the exercise trial, immediately after the exercise trial and 1 hour after the cessation of exercise.
Secondary outcome [16] 402101 0
Total peripheral resistance will be measured by the Human NIBP Nano System (AD Instruments) and assessed as a composite secondary outcome.
Timepoint [16] 402101 0
Baseline (before each bout of exercise), 15 minutes into the exercise trial, immediately after the exercise trial and 1 hour after the cessation of exercise.

Eligibility
Key inclusion criteria
1. Aged between 18-45 years; or 65-80 years
2. Free from cardiovascular disease.
3. Body mass index (BMI) <35
4. Free from any signs or symptoms of fever or upper respiratory tract infections.
5. Free from any musculoskeletal injuries or other conditions that would restrict the individual's ability to perform exercise safely.
6. Non-smoker
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Previous diagnosis of myocardial infarction, stroke or angina.
2. Vaccination for SARS-COV-2 within the past 1 month or scheduled SARS-COV-2 booster vaccine within the timeline of the trial.
3. Signs and symptoms of fever or respiratory infection within the past 2 weeks.
4. Body mass index (BMI) >35
5. Osteoporosis - bone mineral density (t-score) < -2.5
6. Severe depression, anxiety and/or stress according to the DASS; or diagnosis of psychotic disorder.
7. Currently taking medication for cancer or immunological disorder.
8. A musculoskeletal injury that inhibits the individual's ability to perform exercise safely.
9. Evidence of substance abuse (e.g. pharmaceuticals, alcohol or other narcotics)

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation according to age (e.g. the 18-45 y group and the 65-80 y group). Ping pong balls labelled 1 or 2 (the numbers will be defined as a specific order of the trial arms (2 interventions) will be drawn from an opaque container after brief shaking. This will be done multiple times for each age group until all participants have been assigned a trial arm sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
20 individuals will provide sufficient statistical power (>80%) at an alpha of 0.05, to detect a meaningful change in telomerase/TERT and difference amongst the young adults compared to the older adults after the two bouts of exercise (F=0.35). We plan to recruit up to 24 individuals to account for potential drop out (20%)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
1/09/2022
Date of last participant enrolment
Anticipated
29/12/2023
Actual
Date of last data collection
Anticipated
12/01/2024
Actual
Sample size
Target
24
Accrual to date
13
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 35269 0
4220 - Burleigh
Recruitment postcode(s) [2] 35270 0
4220 - Miami
Recruitment postcode(s) [3] 35271 0
4305 - Ipswich
Recruitment postcode(s) [4] 35272 0
4000 - Brisbane
Recruitment postcode(s) [5] 35273 0
4217 - Gold Coast

Funding & Sponsors
Funding source category [1] 309543 0
University
Name [1] 309543 0
University of Southern Queensland
Country [1] 309543 0
Australia
Primary sponsor type
University
Name
University of Southern Queensland
Address
University of Southern Queensland, School of Health and Wellbeing, Ipswich Campus, Ipswich, 11 Salisbury Road, Ipswich, QLD, 4305
Country
Australia
Secondary sponsor category [1] 310542 0
None
Name [1] 310542 0
Address [1] 310542 0
Country [1] 310542 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309324 0
University of Southern Queensland Human Research Ethics
Ethics committee address [1] 309324 0
Ethics committee country [1] 309324 0
Australia
Date submitted for ethics approval [1] 309324 0
11/10/2021
Approval date [1] 309324 0
19/11/2021
Ethics approval number [1] 309324 0
USQ HRE - H21REA237

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

Contacts
Principal investigator
Name 113766 0
Dr Josh Denham
Address 113766 0
University of Southern Queensland
School of Health and Wellbeing
B202, Ipswich Campus, Ipswich, 4305
Queensland, Australia
Country 113766 0
Australia
Phone 113766 0
+61 7 3812 6347
Fax 113766 0
Email 113766 0
[email protected]
Contact person for public queries
Name 113767 0
Josh Denham
Address 113767 0
University of Southern Queensland
School of Health and Wellbeing
B202, Ipswich Campus, Ipswich, 4305
Queensland, Australia
Country 113767 0
Australia
Phone 113767 0
+61 7 3812 6347
Fax 113767 0
Email 113767 0
[email protected]
Contact person for scientific queries
Name 113768 0
Josh Denham
Address 113768 0
University of Southern Queensland
School of Health and Wellbeing
B202, Ipswich Campus, Ipswich, 4305
Queensland, Australia
Country 113768 0
Australia
Phone 113768 0
+61 7 3812 6347
Fax 113768 0
Email 113768 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?
Anonymous (de-identified) data will be shared upon email request.
When will data be available (start and end dates)?
Data will be available at the completion of the project. Data will be available for 5 years after the completion of the project.
Available to whom?
Researchers from a scientific or academic institute.
Available for what types of analyses?
For the aims approved in the proposal (e.g. for meta-analytical studies).
How or where can data be obtained?
From the principal investigator by email request.
Principal investigator: Dr Joshua Denham
email: [email protected]


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.