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Trial registered on ANZCTR


Registration number
ACTRN12616001390471
Ethics application status
Approved
Date submitted
29/09/2016
Date registered
7/10/2016
Date last updated
9/12/2021
Date data sharing statement initially provided
5/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of aerobic exercise training on cardiovascular function in aged adults with and without type 2 diabetes
Scientific title
The effect of aerobic exercise training on cardiovascular function in aged adults with and without type 2 diabetes
Secondary ID [1] 290231 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 300420 0
Cardiovascular health 300421 0
Condition category
Condition code
Cardiovascular 300281 300281 0 0
Coronary heart disease
Metabolic and Endocrine 300307 300307 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adults aged 50 years and older with and without type 2 diabetes will perform a 12 week supervised, group-based aerobic exercise programme that includes cycle, rowing and walking/running exercise. For the entire 12 week intervention, exercise prescription will be 4 weekly exercise sessions for 45-60 minutes. Initial exercise prescription includes 3 moderate-intensity (50-75% of VO2peak), continuous exercise sessions and 1 interval type exercise session (75-95% of VO2peak). At the 4 week period, a moderate-intensity continuous training session will be substituted for another interval-type exercise session for the remainder of the exercise intervention. Exercise sessions will be supervised by exercise physiologists.

Adults aged 35-49 years will not perform the exercise intervention and serve as an age comparator to baseline data (prior to exercise training) of adults aged 50 years and older.
Intervention code [1] 296008 0
Lifestyle
Intervention code [2] 296030 0
Treatment: Other
Comparator / control treatment
Adults aged 35-80 years without type 2 diabetes, with no chronic medical problems and not currently taking any cardiovascular or renal medications. All control participants will have a exercise history of less than 150 minutes per week of moderate-intensity aerobic exercise over the prior 6 months. Healthy adults aged 50 years and older without type 2 diabetes will perform the 12 week exercise intervention.
Control group
Active

Outcomes
Primary outcome [1] 299759 0
Exercise capacity (VO2peak) via breath-by-breath gas analysis during incremental cycle exercise
Timepoint [1] 299759 0
12 weeks after enrollment
Primary outcome [2] 299760 0
Left ventricular function during sub-maximal (35%, 55% and 75% of VO2peak) upright cycle exercise using carbon dioxide rebreathing method and left and right ventricular function during sub-maximal (100 and 120 beats per minute) supine cycle exercise using MRI
Timepoint [2] 299760 0
12 weeks after enrollment
Secondary outcome [1] 328042 0
Nil
Timepoint [1] 328042 0
Nil

Eligibility
Key inclusion criteria
Type 2 diabetes group:
Diagnosed for at least 6 months but not longer 10 years
Aged 35-80 years
Performing less than 150 minutes per week of moderate intensity aerobic exercise over the prior 6 months.

Healthy control group (without Type 2 Diabetes):
Aged 35-80 years
Performing less than 150 minutes per week of moderate intensity aerobic exercise over the prior 6 months.
Minimum age
35 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diagnosed type 2 diabetes for less than 6 months or longer than 10 years
Hypertension
Heart failure
Chronic obstructive pulmonary disease
Coronary artery disease (as evidenced by angina or prior myocardial infarction)
Cerebrovascular disease (as evidenced by prior transient ischemic attack or stroke)
Renal disease

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Training-related changes in exercise capacity will be compared with paired t-tests. To
determine the interaction effects of group and time on exercise variables, a repeated measures analysis of variance (ANOVA) will be performed. Secondary analysis (post-hoc testing) will be performed if an interaction effect that includes time achieves a p value <0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2016
Actual
6/09/2017
Date of last participant enrolment
Anticipated
1/08/2022
Actual
Date of last data collection
Anticipated
23/12/2022
Actual
Sample size
Target
50
Accrual to date
25
Final
Recruitment outside Australia
Country [1] 8269 0
New Zealand
State/province [1] 8269 0
Auckland

Funding & Sponsors
Funding source category [1] 294594 0
Government body
Name [1] 294594 0
The Health Research Council of New Zealand
Country [1] 294594 0
New Zealand
Primary sponsor type
University
Name
The Univeristy of Auckland
Address
Research office
Building 620
Level 10
49-51 Symonds St
Auckland, 1010
Country
New Zealand
Secondary sponsor category [1] 293476 0
None
Name [1] 293476 0
Address [1] 293476 0
Country [1] 293476 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296041 0
Health and Disability Ethics Committee
Ethics committee address [1] 296041 0
Ministry of Health
Ethics Department
Freyberg Building
20 Aitken Street
Wellington, 6011
Ethics committee country [1] 296041 0
New Zealand
Date submitted for ethics approval [1] 296041 0
20/10/2016
Approval date [1] 296041 0
26/10/2016
Ethics approval number [1] 296041 0
16/STH/174

Summary
Brief summary
Diabetes mellitus is a significant health issue in New Zealand, with a high prevalence reported in adults aged 50 years and over (older adults) and in Maori and Pacific people. Cardiovascular disease is the leading cause of mortality in adults with type 2 diabetes mellitus (T2D).

Human aging and T2D are associated with a diminished exercise capacity, which is strongly associated with the development and progression of many chronic diseases (cardiovascular disease, obesity, some types of cancers) and a higher risk of cardiovascular-related and all-cause mortality.

There is substantial evidence to support the hypothesis that structural adaptations including the accumulation of collagen, advanced glycation end products (AGE’s) and triglycerides contribute to the stiffening and dysfunction of the aged heart and blood vessels. Stiffening of the cardiovascular system is believed to play a key role in the pathophysiology of several cardiovascular conditions (systolic hypertension, stroke, atrial fibrillation, congestive heart failure) that affect older adults.

People with T2D experience a greater accumulation of these toxic metabolites and thus T2D may accelerate the cardiovascular aging process. Indeed, abnormalities in measures of left ventricular diastolic function are more prevalent in humans with T2D compared to healthy controls. Moreover, a smaller left ventricular stroke volume and end-diastolic volume during exercise in people with T2D suggest that the reduction in exercise capacity in people with T2D may be primarily related to a smaller exercise stroke volume secondary to impaired diastolic function.

Regular physical exercise training increases exercise capacity in previously sedentary older adults with T2D; however, no studies have assessed changes in exercise stroke volume before and after training. Therefore, it remains unclear whether increases in exercise capacity with regular and sustained exercise training in older adults with T2D are associated with improved left ventricular function.

The aim of this project is to examine the consequences of T2D on cardiovascular function in adults aged 35-80 years. Adults aged 50 years and older with and without T2D will perform a 12 week exercise training programme to examine the effect of exercise training on maximal exercise capacity and left ventricular function during exercise.

A comprehensive set of baseline testing and follow-up testing will take place to assess the effects of a 12 week exercise-based intervention. This testing will include submaximal and maximal exercise testing and non-invasive imaging (MRI) of cardiac structure and function at rest and during exercise.

We hypothesize that aging will result in a reduction in exercise capacity and left ventricular function during exercise, which will be further reduced in people with T2D. 12 weeks of exercise training will improve exercise capacity and left ventricular function during exercise in older adults with T2D.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69318 0
Dr Graeme Carrick-Ranson
Address 69318 0
STaR Centre
Faculty of Medical and Health Sciences
The University of Auckland
22-30 Park Avenue
Grafton
Auckland 1023
New Zealand
Country 69318 0
New Zealand
Phone 69318 0
+64 022 646 9054
Fax 69318 0
Email 69318 0
g.ranson@auckland.ac.nz
Contact person for public queries
Name 69319 0
Stacey Reading
Address 69319 0
Department of Exercise Sciences University of Auckland, Building 907, Suiter Street,
Newmarket, Auckland, 1023
Country 69319 0
New Zealand
Phone 69319 0
+64 9 3737599
Fax 69319 0
+64 09 373 7043
Email 69319 0
s.reading@auckland.ac.nz
Contact person for scientific queries
Name 69320 0
Graeme Carrick-Ranson
Address 69320 0
Faculty of Medical and Health Sciences
The University of Auckland
22-30 Park Avenue
Grafton
Auckland 1023
New Zealand
Country 69320 0
New Zealand
Phone 69320 0
+64 022 646 9054
Fax 69320 0
Email 69320 0
g.ranson@auckland.ac.nz

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 used in the published results (text, tables, figures) of the study after de-identification
When will data be available (start and end dates)?
Begining three months and ending 3 years following article publication
Available to whom?
Case-by-case basis at the discretion of Primary Investigator
Available for what types of analyses?
For any analysis
How or where can data be obtained?
Access subject to approval by Principal Investigator (Graeme.Carrick-Ranson@unisa.edu.au, +61 8 830 21897).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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