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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, aged 55 or over, 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 participantís 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 Current inclusion criteria as of 08/04/2013:
1. Patients with diagnosed type 2 diabetes at least for three months;
2. Both genders;
3. Age ≥ 55 years;
4. Non-smokers;
5. Not engaged in supervised exercise;
6. Community-dwelling;
7. Medical recommendation for lifestyle intervention;
8. Known medical history;
9. Diabetes complications under medical control (metabolic discontrol, diabetic foot, diabetic retinopathy, diabetic nephropathy, diabetic autonomic neuropathy and cardiovascular risk);
10. No cardiovascular, respiratory and musculoskeletal contraindications to exercise;
11. No gait and balance problems;
12. Not taking insulin for less than three months;
13. Volunteer participation with signed informed consent.

Previous inclusion criteria until 08/04/2013:
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 Current exclusion criteria as of 08/04/2013:
1. Participation in another supervised exercise program;
2. Changes in diabetes and cardiovascular medications;
3. Exercise adherence less than 65%;
4. Aggravation of diabetes complications or other major health problem.

Previous exclusion criteria until 08/04/2013:
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 Completed
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
  Email 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
  Email cidesd.geral@utad.pt
  Sponsor website: http://www.utad.pt
Date applied 16/12/2012
Last edited 08/04/2013
Date ISRCTN assigned 28/12/2012
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