Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001193369
Ethics application status
Approved
Date submitted
11/08/2017
Date registered
16/08/2017
Date last updated
2/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of cardiovascular disease and dynamic endurance exercise training on cardiovascular function in middle-aged and older women.
Scientific title
The effect of cardiovascular disease and dynamic endurance exercise training on cardiovascular function in middle-aged and older women.
Secondary ID [1] 292403 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary heart disease 304297 0
Cardiovascular health 304306 0
Condition category
Condition code
Cardiovascular 303323 303323 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women aged 50-80 years with and without cardiovascular disease will perform a 16-week supervised, group-based dynamic endurance exercise programme. The exercise prescription will be individualised and we aim to keep the training flexible and alter mode, duration or intensity if necessary (e.g. to suit fitness level or any limitations to particular modes of exercise).

The programme includes a combination of cycling, rowing and walking/jogging exercise. During the first 4 weeks, exercise prescription will include 3 moderate-intensity (50-75% of VO2peak) continuous exercise sessions with a duration of 45 minutes. Once tolerated (generally within the first 4 weeks), exercise duration will be increased to 60 minutes for the remainder of the intervention. At week 4 and 8, a moderate intensity continuous training session will be substituted for an interval type session. Following a 10 minute moderate intensity warm-up, the participant will perform two minutes of vigorous-intensity (80-95% VO2peak) exercise followed by three minutes of active recovery (40-60%VO2 peak). This work-recovery protocol will be repeated five times.

Exercise sessions will be supervised by exercise physiologists.

A strategy to promote adherence to the exercise programme will be implemented. Researchers will stay in contact with participants throughout the exercise programme and exercise sessions will be monitored when changes are made to the programme, or as requested by the participant. Participants will be encouraged to contact the researchers if they have any queries or concerns about their exercise programme, and we aim to keep the programme flexible and individualised.

Heart rate will be monitored during all exercise sessions using a provided Polar heart rate monitor and watch. This data will be used to quantify exercise training volume and adherence to the exercise programme.
Intervention code [1] 298572 0
Lifestyle
Intervention code [2] 298838 0
Treatment: Other
Comparator / control treatment
Women aged 50-80 years without cardiovascular disease with no chronic medical problems and not currently taking any cardiovascular or renal medications. All control participants will have an exercise history of less than 150 minutes per week of moderate-intensity dynamic endurance-type exercise over the prior 6 months. All healthy women will perform the 16-week exercise intervention.
Control group
Active

Outcomes
Primary outcome [1] 302709 0
Maximum exercise capacity (peak oxygen uptake, VO2 peak) via the analysis of expired gas fractions and volumes with a metabolic cart during an incremental upright cycle test to volitional exhaustion.
Timepoint [1] 302709 0
Prior and after 16-weeks of exercise training
Primary outcome [2] 302710 0
Stroke volume during sub-maximal upright cycle exercise via the non-invasive CO2 rebreathing techique
Timepoint [2] 302710 0
Prior and after 16-weeks of exercise training
Primary outcome [3] 303077 0
Stroke volume during maximal upright cycle exercise via the non-invasive CO2 rebreathing techique
Timepoint [3] 303077 0
Prior and after 16-weeks of exercise training
Secondary outcome [1] 336786 0
Peripheral (calf) vascular conductance during supine rest via venous occlusion plethysmography using indium-gallium strain gauge
Timepoint [1] 336786 0
Prior and after 16-weeks of exercise training
Secondary outcome [2] 337800 0
Peripheral metaboreflex control of blood pressure via manual auscultation of the brachial artery during ischemic rhythmic handgrip exercise
Timepoint [2] 337800 0
Prior and after 16-weeks of exercise training
Secondary outcome [3] 337801 0
5-day physical activity levels via an accelerometer
Timepoint [3] 337801 0
Prior and after 16-weeks of exercise training
Secondary outcome [4] 337802 0
Health-related quality of life via a Short-form 36 Quality of life questionnaire
Timepoint [4] 337802 0
Prior and after 16-weeks of exercise training
Secondary outcome [5] 337841 0
Maximal peripheral (calf) vascular conductance via venous occlusion plethysmography using an indium-gallium strain gauge, assessed after ischemic calf extensions
Timepoint [5] 337841 0
Prior and after 16-weeks of exercise training
Secondary outcome [6] 337848 0
Peripheral metaboreflex control of heart rate via 3-lead ECG during ischemic rhythmic handgrip exercise
Timepoint [6] 337848 0
Prior and after 16-weeks of exercise training
Secondary outcome [7] 337849 0
Left ventricular end-diastolic and end-systolic volume via MRI
Timepoint [7] 337849 0
Prior and after 16-weeks of exercise training
Secondary outcome [8] 337852 0
Peripheral metaboreflex control of blood flow via venous occlusion plethysmography using indium-gallium strain gauge during ischemic rhythmic handgrip exercise
Timepoint [8] 337852 0
Prior and after 16-weeks of exercise training

Eligibility
Key inclusion criteria
Cardiovascular disease cohort
Women aged 50-80 years
Have had a documented prior event or surgical intervention associated with coronary heart disease including but not limited to myocardial infarction, percutaneous coronary intervention and/or coronary artery bypass graft.
Performing less than 150 minutes per week of moderate-intensity dynamic exercise over the prior 6 months.

Healthy control (without cardiovascular disease) cohort.
Women aged 50-80 years
Performing less than 150 minutes per week of moderate-intensity dynamic exercise over the prior 6 months.
Minimum age
50 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Heart failure
Significant cardiac arrhythmia or severe valvular disease
Cerebrovascular disease (as evidenced by previous stroke or transient ischemic attack)
Severe obesity (BMI>40kg/m2)
High levels of frailty (assessed by clinical frailty scale)
Chronic obstructive pulmonary disease
Renal disease
Recent (<4 wk) hospital admission with a cardiac event

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The effect of cardiovascular disease on peak exercise capacity and participant characteristics will be assessed by Student's t-test. To determine the interaction effects of group and exercise condition 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.

Training-related changes in peak exercise capacity and participant characteristics will be assessed with paired t-tests. To determine interaction effects of group and time point 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
1/04/2018
Actual
12/07/2018
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
22/04/2021
Actual
Sample size
Target
50
Accrual to date
1
Final
Recruitment outside Australia
Country [1] 9043 0
New Zealand
State/province [1] 9043 0
Auckland

Funding & Sponsors
Funding source category [1] 296954 0
University
Name [1] 296954 0
The University of Auckland
Country [1] 296954 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Research office
Building 620
Level 10
49-51 Symonds St
Auckland, 1010
Country
New Zealand
Secondary sponsor category [1] 295959 0
None
Name [1] 295959 0
Address [1] 295959 0
Country [1] 295959 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298159 0
Health and Disability Ethics Committee
Ethics committee address [1] 298159 0
Ministry of Health
Ethics Department
Freyberg Building
20 Aitken Street
Wellington, 6011
Ethics committee country [1] 298159 0
New Zealand
Date submitted for ethics approval [1] 298159 0
21/08/2017
Approval date [1] 298159 0
08/11/2017
Ethics approval number [1] 298159 0
17/NTA/197
Ethics committee name [2] 301591 0
Auckland District Health Board Research Review Committee (ADHB-RRC)
Ethics committee address [2] 301591 0
Research Office
Level 14, Support Building
Auckland City Hospital
PB 92024, Grafton, Auckland
Ethics committee country [2] 301591 0
New Zealand
Date submitted for ethics approval [2] 301591 0
30/04/2018
Approval date [2] 301591 0
19/06/2018
Ethics approval number [2] 301591 0
A+8051

Summary
Brief summary
Cardiovascular disease (CVD) is a significant health and life-threatening chronic disease in New Zealand women.

CVD is associated with a diminished exercise capacity, which is particularly profound in women. A low exercise capacity has severe clinical consequences as it is strongly associated with the development of chronic disease (heart failure, stroke, obesity, some forms of cancer), and cardiovascular-related and all-cause mortality. Although women with CVD have a high risk of poor clinical outcomes, there has been scarce research examining cardiovascular function in this patient population.

Regular exercise increases exercise capacity and cardiovascular function in healthy young adults. Young and older healthy females demonstrate a blunted cardiovascular adaptation to dynamic (endurance) exercise training compared to their male peers. Despite evidence that suggests that women have a unique response to dynamic exercise training, there is very limited data comprehensively describing the cardiovascular adaptations to exercise training in late middle-aged and older women with and without CVD. Understanding how women with CVD respond to exercise training has important implications for prescribing exercise programmes to women in cardiac rehabilitation to achieve optimal health outcomes.

Thus, the global objective of this study is to examine the effects of CVD and dynamic (endurance) exercise training on cardiovascular function and circulatory control in late middle-aged and older (50-80 yr) women. Secondary outcomes include physical activity levels and physical and health-related quality of life.

A comprehensive array of physiological measurements will be collected to examine the effects of CVD and a 16-week exercise-based intervention on cardiac and blood vessel function. This testing will include sub-maximal and maximal exercise testing, and resting and exercise cardiac and vascular function measurements.

There are two main hypotheses attached to this project;
Hypothesis 1: It is hypothesized that women with CVD will have a markedly impaired exercise capacity, cardiovascular function during exercise, quality of life and physical activity levels compared to aged-similar healthy controls.

Hypothesis 2: It is hypothesized that four-months of dynamic exercise training will improve exercise capacity, cardiovascular function during exercise, quality of life and physical activity levels in women with CVD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76182 0
Dr Graeme Carrick-Ranson
Address 76182 0
Department of Exercise Sciences
University of Auckland
Building 731,
261 Morrin Rd,
St Johns,
Auckland, 1072
Country 76182 0
New Zealand
Phone 76182 0
+64 09 373 6849
Fax 76182 0
+64 09 373 7043
Email 76182 0
[email protected]
Contact person for public queries
Name 76183 0
Dr Graeme Carrick-Ranson
Address 76183 0
Department of Exercise Sciences
University of Auckland
Building 731,
261 Morrin Rd,
St Johns,
Auckland, 1072
Country 76183 0
New Zealand
Phone 76183 0
+64 09 373 6849
Fax 76183 0
+64 09 373 7043
Email 76183 0
[email protected]
Contact person for scientific queries
Name 76184 0
Dr Graeme Carrick-Ranson
Address 76184 0
Department of Exercise Sciences
University of Auckland
Building 731,
261 Morrin Rd,
St Johns,
Auckland, 1072
Country 76184 0
New Zealand
Phone 76184 0
+64 09 373 6849
Fax 76184 0
+64 09 373 7043
Email 76184 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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