Skip to content

Exercise for people living with obesity, diabetes and heart disease: clinical and functional outcomes and quality of life.

Exercise training for people living with obesity-related diabetes and cardiovascular disease: clinical and functional outcomes and quality of life

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000360415
Enrollment
62
Registered
2007-07-04
Start date
2007-09-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Associate Professor Steve Selig
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026