Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000360415
Ethics application status
Not yet submitted
Date submitted
25/06/2007
Date registered
4/07/2007
Date last updated
4/07/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise for people living with obesity, diabetes and heart disease: clinical and functional outcomes and quality of life.
Scientific title
Exercise training for people living with obesity-related diabetes and cardiovascular disease: clinical and functional outcomes and quality of life
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity
 1917 0
Type II Diabetes (T2DM) complicated with Cardiovascular Disease 1918 0
Condition category
Condition code
Diet and Nutrition 2008 2008 0 0
Obesity
Metabolic and Endocrine 2009 2009 0 0
Diabetes
Cardiovascular 2010 2010 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise training studies have shown exercise to be beneficial for people with T2DM in the absence of symptomatic cardiovascular disease and, separately, for those with cardiovascular disease in the absence of T2DM. The intended studies will bring together these two groups of individuals that merge clinically in more advanced stages of disease. Until now, these patients with multiple morbidity have been excluded from almost all exercise interventions, but make up substantial patient numbers for those with primary diagnoses for either diabetes or cardiovascular disease.

In this project, aerobic and resistance (strength) exercise training will be combined for volunteers with obesity-related T2DM, complicated by cardiovascular disease. By introducing combined aerobic and resistance exercise to this group of volunteers this may improve exercise and functional capacities, glucose control and quality of life.

This is a randomised clinical trial with participants randomised to either the Exercise or Control groups after a series of baseline tests comprising aerobic and strength capacities, functional capacities, glucose control and quality of life (QoL). The aerobic and resistance exercise training intervention is for 6 months at moderate intensities and will be supervised for the first 2 months in a hospital gymnasium, with the remaining 4 months in community fitness centres. . The Control group will undergo sham exercise training, consisting of stretching exercises.

During the 24 week study, volunteers will attend the exercise facility on three days per week.
The aerobic and resistance training exercise group will perform 20 minutes of aerobic exercise at a heart rate intensity equivalent to 50 – 60 % of VO2peak determined at baseline (0 wk) and then gradually increased so that by week 4 the volunteers will be exercising at between 60 - 70% of VO2peak. The aerobic exercise will be performed using a cycle ergometer. . As volunteers progress, they will gradually be given more choice of exercise modes such as walking on treadmill, rowing and stair climbing.

While for moderate intensity resistance training (dynamic exercise involving concentric and eccentric contractions) will be performed for 30 minutes. During the first and second weeks of training, the resistance will be set at 50-60% of each individual 3 RM that is determined at baseline (0 wk). Further, each individual will continue the targeted resistance at 60 - 70 % of current 3 RM.

Prior to each session the volunteers will need 5 – 10 minutes warm up and end with a 5 – 10 minutes cool down and stretching period.

The resistance training program for the Moderate Intensity group will use free weights and a multiple station weight machine. Eight exercises will be used for training; bench press, leg extension, upright row, lateral pull down, standing leg curl, dumbbell seated biceps curl, dumbbell triceps kickback, and abdominal curl. All volunteers need to perform each repetition in a slow, controlled manner, with rest of 90 – 120s between sets. Three sets of 8 – 10 repetitions will be perform for all exercises.

All sessions will be supervised to ensure volunteers perform the exercise using the correct techniques and appropriate amount of weight and rest intervals. Training workload will be increased regularly as tolerated especially for the High Intensity group. At 12 weeks the 3 RM test will be repeated to establish a new baseline

Subjects will not be blinded to treatment and will be informed that they should see improvement in flexibility as an outcome.
Intervention code [1] 1850 0
Prevention
Comparator / control treatment
The sham exercise group will be assigned activities that don’t elicit change in muscle strength or cardiovascular fitness. Each session will involve stationary cycle for 5 minutes with very light resistance (25 W) followed by a series of static stretching exercises for about 30 minutes.
Control group
Placebo

Outcomes
Primary outcome [1] 2835 0
Combined aerobic and resistance exercise training in people living with obesity-related diabetes and cardiovascular will:
1. increase (improve) VO2peak
Timepoint [1] 2835 0
Each measurement will be taken when the pre-study begins, at a 2 months interval and post completion (after 6 months)
Primary outcome [2] 2836 0
Combined aerobic and resistance exercise training in people living with obesity-related diabetes and cardiovascular will:
2. decrease (improve) HbA1c.
Timepoint [2] 2836 0
Each measurement will be taken when the pre-study begins, at a 2 months interval and post completion (after 6 months)
Secondary outcome [1] 4782 0
Combined aerobic and resistance exercise training in people living with obesity-related diabetes and cardiovascular will improve:
1. musculoskeletal strength and endurance
2. functional capacity, improve quality of life (QoL)
3. blood pressure
4. lipid profile
5. flow-mediated dilation of the brachial artery.
Timepoint [1] 4782 0
All the experimental measures taken when the pre-study begins at baseline, at a 2 months interval and post completion (after 6 months).

Eligibility
Key inclusion criteria
Volunteers T2DM with waist girth > 102 cm for males and > 88 cm for females and cardiovascular co-morbidity manifested by one or more of these;-Hypertension;Ischemic Heart Disease, but no current angina;Post Angioplasty / Stent or Post CABG;Chronic Heart Failure New York Association (NYHA I, II or III but not IV) in the absence of congestive heart failure at the time of study;Stable pharmacological therapy;All T2DM candidates HbA1c range should between 7 – 10 %.Volunteers must be sedentary with less than 30 minutes of strength training and/or moderate/vigorous aerobic exercise per week for at least 3 months prior to commencement in the study.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of myocardial infarction, Cardiac arrest, symptomatic or sustained ventricular tachycardia in the previous 6 months;Unstable heart failure with NYHA Class IV patients;Positive Stress Test or current anginaCurrent musculoskeletal (e.g. arthritis) and/or neurological impairments that adversely affect exercise capacity;Baseline assessment suggesting unsatisfactory control of heart failure, Symptoms preventing the undertaking of exercise, Exercise-induced ventricular tachycardia (symptomatic or sustained) orBlood pressure drop of more 20 mmHg during baseline exercise test (VO2peak).All volunteers will be advised to continue taking individual medications.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Austin Health Cardiology, Austin Health Endocrinology and International Diabetes Institute (IDI) serve as a study centre for the recruitment and implementation of the intervention. Allocation concealment procedures where volunteers will be grouped according to generated random numbers held in sealed envelopes by a third party.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The 62 volunteers will be grouped using a simple randomisation table created by computer software (i.e., computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
62
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2152 0
Charities/Societies/Foundations
Name [1] 2152 0
National Heart Foundation grant
Country [1] 2152 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Steve Selig
Address
Country
Secondary sponsor category [1] 1953 0
Individual
Name [1] 1953 0
Professor Tony Morris
Address [1] 1953 0
Country [1] 1953 0
Secondary sponsor category [2] 1954 0
Individual
Name [2] 1954 0
Associate Professor David Dunstan
Address [2] 1954 0
Country [2] 1954 0
Secondary sponsor category [3] 1955 0
Individual
Name [3] 1955 0
Professor George Jerums
Address [3] 1955 0
Country [3] 1955 0
Secondary sponsor category [4] 1956 0
Individual
Name [4] 1956 0
Associate Professor David Hare
Address [4] 1956 0
Country [4] 1956 0
Secondary sponsor category [5] 1957 0
Individual
Name [5] 1957 0
Dr Mohd Nahar Azmi Mohamed
Address [5] 1957 0
Country [5] 1957 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3946 0
VICTORIA UNIVERSITY HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 3946 0
Ethics committee country [1] 3946 0
Australia
Date submitted for ethics approval [1] 3946 0
Approval date [1] 3946 0
Ethics approval number [1] 3946 0
Ethics committee name [2] 3947 0
Austin Health Human Research Ethics Committee
Ethics committee address [2] 3947 0
Ethics committee country [2] 3947 0
Australia
Date submitted for ethics approval [2] 3947 0
Approval date [2] 3947 0
Ethics approval number [2] 3947 0

Summary
Brief summary
This project aims to help people with obesity, Type II diabetes(T2DM) and cardiovascular disease to undertake exercise training as part of a research project.
Exercise is known to help those with diabetes OR heart disease, but there is very little known about the potential benefits for those with BOTH.

In this study we will examine the effects of exercise to improve your:
1) energy and ability to perform normal everyday activities (eg. exercise or physical activity for recreation, sport, work or independent living) and your quality of life
2) medical conditions before and after the exercise training
3) capacity to exercise safely and independently

We expect that the benefits to you for your participation will include improving your fitness, improving your blood sugar level and maintaining the sugar level within the normal limits. Good blood sugar level control may prevent further worsening of diabetes and further complications of heart disease conditions. You may also emotionally feel great and confidence within yourself. We would also like to see improvements in your quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27664 0
Address 27664 0
Country 27664 0
Phone 27664 0
Fax 27664 0
Email 27664 0
Contact person for public queries
Name 11039 0
Associate Professor Steve Selig
Address 11039 0
School of Human Movement, Recreation & Performance
Room L314
Level 1 Building L
Victoria University
Corner Ballarat and Geelong Roads
Footscray VIC 3011

Postal Address:
PO Box 14428
Melbourne VIC 8001
Country 11039 0
Australia
Phone 11039 0
+61 3 99194421
Fax 11039 0
+61 3 99195532
Email 11039 0
[email protected]
Contact person for scientific queries
Name 1967 0
Associate Professor Steve Selig
Address 1967 0
School of Human Movement, Recreation & Performance
Room L314
Level 1 Building L
Victoria University
Corner Ballarat and Geelong Roads
Footscray VIC 3011

Postal Address:
PO Box 14428
Melbourne VIC 8001
Australia
Country 1967 0
Australia
Phone 1967 0
+61 3 99194421
Fax 1967 0
+61 3 99195532
Email 1967 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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