Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/12/2012
Date assigned
28/12/2012
Last edited
25/07/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English 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 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

Trial website

http://www.diabetesemmovimento.com

Contact information

Type

Scientific

Primary contact

Dr Romeu Mendes

ORCID ID

Contact details

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
Vila Real
5001-801
Portugal
rmendes@utad.pt

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

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_

Ethics approval

Cova da Beira Hospital Centre Ethics Committee, Portugal, 15/05/2009, ref: 36/2009

Study design

Acute Effects: Randomized crossover trial
Chronic Effects: Longitudinal controlled intervention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Patient information can be found at http://diabetesemmovimento.wordpress.com/inscricoes

Condition

Type 2 diabetes and cardiovascular risk

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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

Overall trial start date

01/01/2013

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

01/01/2013

Recruitment end date

31/12/2013

Locations

Countries of recruitment

Portugal

Trial participating centre

Centro de Investigação em Desporto, Saúde e Desenvolvimento Humano
Vila Real
5001-801
Portugal

Sponsor information

Organisation

University of Trás-os-Montes and Alto Douro (Portugal)

Sponsor details

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
Vila Real
5001-801
Portugal
cidesd.geral@utad.pt

Sponsor type

University/education

Website

http://www.utad.pt

Funders

Funder type

Government

Funder name

Portuguese Foundation for Science and Technology (Portugal) Reference SFRH/BD/47733/2008

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

European Social Fund Reference SFRH/BD/47733/2008

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. Mendes R, Sousa N, Vilaça-Alves J, Themudo-Barata JL, Reis VM. High intensity interval training in patients with type 2 diabetes: Diabetes em Movimento® trial. Cultura, Ciencia y Deporte 2014;9(25 Sup):72.
2. Mendes R, Sousa N, Vilaça-Alves J, Themudo-Barata JL, Reis VM. Resistance training in community-based exercise programas for type 2 diabetics: Diabetes em Movimento® trial. Cultura, Ciencia y Deporte 2014;9(25 Sup):217.
3. Mendes R, Sousa N, Themudo-Barata JL, Reis VM. Effects of an exercise program on physical fitness in patients with type 2 diabetes. Rev Saúde Pública 2014;48(n.esp):220.
4. Mendes R, Sousa N, Reis VM, Themudo-Barata JL. A community-based exercise program to control cardiovascular risk in type 2 diabetics. Rev Saúde Pública 2014;48(n.esp):57.
5. Mendes R, Sousa N, Themudo-Barata JL, Reis VM. Treino intervalado de alta intensidade vs. treino contínuo de intensidade moderada: qual o melhor método para o controlo glicémico agudo em doentes com diabetes tipo 2? Resultados do Diabetes em Movimento® [High intensity interval training vs. moderate intensity continuos training: which is the best method to acute glycemic control in patients with type 2 diabetes? Results from Diabetes em Movimento®]. In: Matos A, Bodas AR, Serôdio AJ, Afonso C, Abrantes C, Afonso D, et al., editors. Atas do Congresso de Ciências do Desporto, Exercício e Saúde. Vila Real: Universidade de Trás-os-Montes e Alto Douro; 2014. p. 54.
6. Mendes R, Sousa N, Reis VM, Themudo Barata JL. Efeitos de um programa comunitário de exercício físico no controlo glicémico e fatores de risco cardiovascular em doentes com diabetes tipo 2: Estudo Diabetes em Movimento® [Effects of a community-based exercise program on glycemic control and cardiovascular risk factors in patients with type 2 diabetes: Diabetes em Movimento® Trial]. Revista Portuguesa de Diabetes 2014;9(S1):36.
7. Mendes R, Sousa N, Reis VM, Themudo-Barata JL. Prevention of exercise-related injuries and adverse events in patients with type 2 diabetes. Postgrad Med J 2013;89(1058):715-21. http://www.ncbi.nlm.nih.gov/pubmed/24194555
8. Mendes R, Dias E, Gama A, Castelo Branco M, Themudo Barata JL. [Exercise practice and habitual physical activity levels in patients with type 2 diabetes: A pilot study in Portugal]. Rev Port Endocrinol Diabetes Metab 2013;8(1):9-15.
9. Mendes R, Sousa N, Reis V, Themudo Barata JL. Diabetes em Movimento® - Programa comunitário de exercício para pessoas com diabetes tipo 2 [Diabetes em Movimento® - Community-based exercise program for patients with type 2 diabetes]. Rev Medicina Desportiva informa 2013;4(4):18-20.
10. Mendes R, Sousa N, Themudo-Barata JL, Reis VM. Como melhorar a aptidão física em doentes com diabetes tipo 2? Estudo piloto do Diabetes em Movimento® [How to improve physical fitness in patients with type 2 diabetes? Diabetes em Movimento® pilot study]. In: Vilaça J, Saavedra F, Fernandes HM, Reis VM, editors. Actas do 3º Simpósio Internacional de Força e Condição Física. Vila Real: Centro de Investigação em Desporto, Saúde e Desenvolvimento Humano; Universidade de Trás-os-Montes e Alto Douro; 2013. p. 70-1.
11. Sousa N, Mendes R. Safety and efficacy of strength training in patients with type 2 diabetes. In: Vilaça J, Saavedra F, Fernandes HM, Reis VM, editors. Actas do 3º Simpósio Internacional de Força & Condição Física. Vila Real: Centro de Investigação em Desporto, Saúde e Desenvolvimento Humano; Universidade de Trás-os-Montes e Alto Douro; 2013. p. 41-2.
12. Mendes R, Sousa N, Reis VM, Themudo Barata JL. Diabetes em Movimento® - Community-based exercise program for patients with type 2 diabetes. Br J Sports Med 2013;47(10):e3.43
13. Mendes R, Sousa N, Garrido N, Rocha P, Themudo Barata JL, Reis VM. Efficacy of acute high-intensity interval training in lowering glycemia in patients with type 2 diabetes: Diabetes em Movimento® pilot study. Br J Sports Med 2013;47(10):e3.11
14. Mendes R, Sousa N, Reis VM, Themudo Barata JL. Diabetes em Movimento® - Programa de Exercício para Doentes com Diabetes Tipo 2 [Diabetes em Movimento® - Exercise program for patients with type 2 diabetes]. Revista Portuguesa de Diabetes 2013;8(S1):20.
15. Mendes R, Sousa N, Reis V, Themudo Barata J. Effects of a community-based exercise program in clinical blood pressure of patients with type 2 diabetes: Diabetes em Movimento® pilot study. In: Balagué N, Torrents C, Vilanova A, Cadefau J, Tarragó R, Tsolakidis E, editors. Book of Abstracts of 18th annual Congress of the European College of Sport Science. Barcelona: European College of Sport Science; 2013. p. 473.
16. Mendes R, Sousa N, Garrido N, Rocha P, Themudo Barata J, Reis V. Safety of high-intensity interval training in patients with type 2 diabetes treated with oral hypoglycemic agents: Diabetes em Movimento® pilot study. In: Balagué N, Torrents C, Vilanova A, Cadefau J, Tarragó R, Tsolakidis E, editors. Book of Abstracts of 18th annual Congress of the European College of Sport Science. Barcelona: European College of Sport Science; 2013. p. 113-4.
17. Mendes R, Sousa N, Reis V, Themudo Barata J. Falls prevention in patients with type 2 diabetes: Results from Diabetes em Movimento® pilot study. Atención Primaria 2013;45(S2):89.
18. Mendes R, Sousa N, Reis V, Themudo Barata J. Effects of Diabetes em Movimento® community-based exercise program on body composition in patients with Type 2 Diabetes. Atención Primaria 2013;45(S2):89-90.
19. Mendes R. Prescrição de exercício para pessoas com diabetes [Exercise prescription for patients with type 2 diabetes]. In: Costa A, Travassos B, Martins J, editors. Livro de Atas do I Congresso em Desporto, Educação e Saúde. Covilhã: Universidade da Beira Interior, Departamento de Ciências do Desporto; 2013. p. 33-5.
20. Sousa S, Mendes R, Sousa N, Reis VM, Themudo-Barata JL, Marques M. Caracterização da Intensidade do Exercício do Programa Diabetes em Movimento® [Characterization of the exercise intensity of Diabetes em Movimento® program]. In: Costa A, Travassos B, Martins J, editors. Livro de Atas do I Congresso em Desporto, Educação e Saúde. Covilhã: Universidade da Beira Interior, Departamento de Ciências do Desporto; 2013. p. 80.
21. Mendes R, Sousa N, Reis VM, Themudo Barata JL. Diabetes em Movimento® - Programa Comunitário de Exercício para Pessoas com Diabetes Tipo 2 [Diabetes em Movimento® - Community-based exercise program for patients with type 2 diabetes]. Livro de Resumos do XI Congresso Nacional da Sociedade Portuguesa de Medicina Desportiva / II Jornadas Médico Desportivas de Guimarães; Guimarães 2012. p. 41.
22. Mendes R, Sousa N, Pon J, Reis VM, Themudo Barata JL. Eventos adversos associados ao exercício em doentes com diabetes tipo 2 - estudo da fase piloto do Diabetes em Movimento® um programa comunitário de exercício para pessoas com diabetes tipo 2 [Exercise-related adverse events in patients with type 2 diabetes: pilot study of Diabetes em Movimento® a community-based exercise program for patients with type 2 diabetes]. Livro de Resumos do XI Congresso Nacional da Sociedade Portuguesa de Medicina Desportiva / II Jornadas Médico Desportivas de Guimarães; Guimarães 2012. p. 19.
23. Mendes R, Sousa N, Dias F, Domingues M, Marinho D, Reis VM, et al. Programa comunitário de exercício para pessoas com diabetes tipo 2 - estudo da frequência e aderência ao exercício durante a fase piloto do Diabetes em Movimento® [Community-based exercise program for patients with type 2 diabetes: exercise adherence and frequency during Diabetes em Movimento® pilot study]. Livro de Resumos do X Curso Pós-Graduado sobre Envelhecimento: Geriatria Prática; Coimbra 2012. p. 17.
24. Mendes R, Sousa N, Reis VM, Themudo Barata JL. Programa de Exercício na Diabetes Tipo 2 [Exercise program for type 2 diabetes]. Revista Portuguesa de Diabetes 2011;6(2):62-70.
25. Feliciano E, Mendes R, Sousa N, Reis VM, Themudo Barata JL, editors. Programas de Exercício e de Alimentação na Diabetes Tipo 2: Abordagem Pratica [Exercise and nutrition programs in type 2 diabetes: Practical approach ]. 2ª ed. Lisboa: Heartbrain Lda; 2011.
26. Mendes R, Sousa N, Reis V, Themudo Barata JL. Actividade Física na Diabetes Tipo 2: Proposta de um Programa de Exercício [Physical activity in type 2 diabetes: an exercise program proposal ]. In: Feliciano E, Mendes R, Sousa N, Reis V, Themudo Barata JL, editors. Programas de Exercício e de Alimentação na Diabetes Tipo 2: Abordagem Prática. 2ª ed. Lisboa: Heartbrain Lda; 2011. p. 5-31.
27. Mendes R, Sousa N, Reis V, Themudo Barata J. Actividade Física na Diabetes Tipo 2: Modelo de um Programa de Exercício [Physical activity in type 2 diabetes: an exercise program model]. Revista Portuguesa de Diabetes 2010;5(S1):46.

Publication citations

  1. Mendes R, Sousa N, Reis VM, Themudo-Barata JL, Prevention of exercise-related injuries and adverse events in patients with type 2 diabetes., Postgrad Med J, 2013, 89, 1058, 715-721, doi: 10.1136/postgradmedj-2013-132222.

Additional files

Editorial Notes