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| [ Print-friendly version ] |
| Diabetes em Movimento® - Community-based exercise program for people with type 2 diabetes |
| ISRCTN | ISRCTN09240628 |
| DOI | 10.1186/ISRCTN09240628 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Diabetes em Movimento® - Community-based exercise program for people with type 2 diabetes |
| Scientific title | Acute and chronic effects of exercise on type 2 diabetes management: influence on glycemic control, insulin resistance, cardiovascular risk factors and physical fitness |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis |
It is hypothesized that different exercise types, intensities and durations have different acute effects on blood glucose and insulin resistance of type 2 diabetic patients.
It is also hypothesized that type 2 diabetic patients who engage in a supervised exercise program improve their glycemic control, cardiovascular risk factors and physical fitness in comparison with a control group without supervised exercise. Protocol of the exercise program that we will used in this study: Mendes R, Sousa N, Reis VM, Themudo Barata JL. Programa de Exercício na Diabetes Tipo 2. Revista Portuguesa de Diabetes 2011;6(2):62-70. http://www.academia.edu/865461/Programa_de_Exercicio_na_Diabetes_Tipo_2_Exercise_program_for_type_2_diabetes_ |
| Lay summary |
Background and study aims
Type 2 diabetes is a chronic disease that affects approximately 12.4% of Portuguese population and is associated with complications such as metabolic discontrol, diabetic foot, retinopathy (persistent or acute damage to the retina of the eye), nephropathy (damage to kidney), coronary artery disease and cerebrovascular disease. Exercise is widely recommended to control of type 2 diabetes and its complications. This study aims to: Determine the acute effects of different exercise types, intensities and durations in glycemic control and insulin resistance Determine the effects of a long term supervised exercise program in glycemic control, cardiovascular risk factors and physical fitness. Who can participate? The Diabetes em Movimento® study aims to recruit about 60 individuals with diagnosed type 2 diabetes, from both genders, age > 17, without major cardiovascular and orthopaedic disease and without gait and balance problems. What does the study involve? Before participation, individuals will be evaluated at all variables analyzed in this study and a treadmill cardiovascular stress test. In the first phase of this study, 30 individuals (intervention group) will be submitted to exercise sessions of different types, intensities and durations. After this phase of acute effects, this group will participate in a long term (9 months) supervise exercise program. The control group (30 individuals) will be advised to continue normal living and not to engage in supervised exercise. All variables will be analyzed every 3 months. What are the possible benefits and risks of participating? Participants can experience an immediate direct benefit from exercise sessions like reduced blood glucose levels and improved insulin sensitivity. Long term participation in a supervised exercise program can lead to a better glycemic control, reduced cardiovascular risk and improved physical fitness. The main risks are exercise-related adverse acute events like hypoglycaemia (low blood sugar), hyperglycemia (high blood sugar), angina pectoris (temporary chest discomfort that occurs when the heart is not getting enough blood), musculoskeletal injuries and dehydration. Proper planning of exercise sessions, and their monitoring by exercise professionals are crucial aspects to guarantee the safety of participants and to prevent this adverse events. Where is the study run from? The Diabetes em Movimento® study has been set up by Research Center in Sports, Health Sciences and Human Development at the University of Trás-os-Montes and Alto Douro. When is the study starting and how long is it expected to run for? Recruitment will start in January 2013. Participants will be enrolled in the study for a period of one year; however, the study will extend beyond this as we intend to evaluate participant’s health over many months. Who is funding the study? Funding has been provided by Portuguese Foundation for Science and Technology. Who is the main contact? Dr. Romeu Mendes rmendes@utad.pt |
| Ethics approval | Cova da Beira Hospital Centre Ethics Committee, Portugal, 15 May 2009; Reference number 36/2009 |
| Study design |
Acute Effects: Randomized crossover trial
Chronic Effects: Longitudinal controlled intervention trial |
| Countries of recruitment | Portugal |
| Disease/condition/study domain | Type 2 diabetes and cardiovascular risk |
| Participants - inclusion criteria |
1. Patients with diagnosed type 2 diabetes
2. Both genders 3. Age ˃ 17 4. Community-dwelling 5. Medical recommendation for lifestyle intervention 6. Known medical history |
| Participants - exclusion criteria |
1. Already engaged in supervised exercise
2. Major cardiovascular and orthopedic disease 3. Gait and balance problems |
| Anticipated start date | 01/01/2013 |
| Anticipated end date | 31/12/2013 |
| Status of trial | Ongoing |
| Patient information material | Patient information can be found at http://diabetesemmovimento.wordpress.com/inscricoes |
| Target number of participants | 60 |
| Interventions |
In acute effects study, participants will be submitted to different exercise sessions (type, intensity and duration) in comparison to a control session of rest (crossover study).
In chronic effects study, participants will engage in a long term supervised exercise program (9 months), 3 sessions per week, 70 minutes duration. Exercise sessions will follow international recommendations for exercise in type 2 diabetes: aerobic, resistance, flexibility and agility exercise. Control group will continue normal living with no supervised exercise. |
| Primary outcome measure(s) |
1. Glycemic control: blood fast glucose, ambulatory capillary glucose and glycated hemoglobin
2. Insulin resistance: Homeostasis Model Assessment (HOMA) and Quantitative Insulin-Sensitivity Check Index (QUICKI) methods 3. Cardiovascular risk factors: blood pressure; blood lipid profile; body mass index, waist circumference; body fat 4. Physical fitness: 6-min Walk Test; 30 Second Chair Stand Test; Timed Get Up and Go Test; Seat and Reach Test |
| Secondary outcome measure(s) |
1. Medication
2. Nutritional Habits 3. Levels of Physical Activity 4. Exercise adherence 5. Exercise frequency 6. Exercise-related acute adverse events 7. Detraining and deconditioning |
| Sources of funding |
1. Portuguese Foundation for Science and Technology (Portugal) Reference SFRH/BD/47733/2008
2. European Social Fund Reference SFRH/BD/47733/2008 |
| Trial website | http://www.diabetesemmovimento.com |
| Publications | |
| Contact name | Dr Romeu Mendes |
| Address |
Centro de Investigação em Desporto, Saúde e Desenvolvimento Humano
Universidade de Trás-os-Montes e Alto Douro Edifício Ciências do Desporto Apartado 1013 Quinta de Prados |
| City/town | Vila Real |
| Zip/Postcode | 5001-801 |
| Country | Portugal |
| rmendes@utad.pt | |
| Sponsor | University of Trás-os-Montes and Alto Douro (Portugal) |
| Address |
Centro de Investigação em Desporto, Saúde e Desenvolvimento Humano
Universidade de Trás-os-Montes e Alto Douro Edifício Ciências do Desporto Apartado 1013 Quinta de Prados |
| City/town | Vila Real |
| Zip/Postcode | 5001-801 |
| Country | Portugal |
| cidesd.geral@utad.pt | |
| Sponsor website: | http://www.utad.pt |
| Date applied | 16/12/2012 |
| Last edited | 15/03/2013 |
| Date ISRCTN assigned | 28/12/2012 |
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