ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Type 2 diabetes

Cardiovascular health

Condition category

Condition code

Cardiovascular

Coronary heart disease

Metabolic and Endocrine

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]

Lifestyle

Intervention code [2]

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]

Exercise capacity (VO2peak) via breath-by-breath gas analysis during incremental cycle exercise

Timepoint [1]

12 weeks after enrollment

Primary outcome [2]

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]

12 weeks after enrollment

Secondary outcome [1]

Nil

Timepoint [1]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

The Health Research Council of New Zealand

Address [1]

Level 3,
110 Stanley St,
Grafton,
Auckland 1010

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Ethics Department
Freyberg Building
20 Aitken Street
Wellington, 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

20/10/2016

Approval date [1]

26/10/2016

Ethics approval number [1]

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

Dr Graeme Carrick-Ranson

Address

STaR Centre
Faculty of Medical and Health Sciences
The University of Auckland
22-30 Park Avenue
Grafton
Auckland 1023
New Zealand

Country

New Zealand

Phone

+64 022 646 9054

Fax

g.ranson@auckland.ac.nz

Contact person for public queries

Name

Stacey Reading

Address

Department of Exercise Sciences University of Auckland, Building 907, Suiter Street,
Newmarket, Auckland, 1023

Country

New Zealand

Phone

+64 9 3737599

Fax

+64 09 373 7043

s.reading@auckland.ac.nz

Contact person for scientific queries

Name

Graeme Carrick-Ranson

Address

Faculty of Medical and Health Sciences
The University of Auckland
22-30 Park Avenue
Grafton
Auckland 1023
New Zealand

Country

New Zealand

Phone

+64 022 646 9054

Fax

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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No additional documents have been identified.

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