A study that evaluates the influence of an exercise program guided and structured combined with sleep hygiene measures on the metabolic changes, sleep disturbances and quality of life in patients with type 2 diabetes.

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-8nb7xf
• Date of registration: 01/02/2012
• Primary sponsor: UFC- Universidade Federal do Ceará - Brazil
• Public title: A study that evaluates the influence of an exercise program guided and structured combined with sleep hygiene measures on the metabolic changes, sleep disturbances and quality of life in patients with type 2 diabetes.
• Scientific title: A Randomized study on the effects of sleep hygiene in glycemic control in patients with type 2 diabetes mellitus - DPAF: Diabetes and Physical Activity in Fortaleza
• Date of first enrolment: 01/12/2010
• Target sample size: 200
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-8nb7xf/
• Study design: Clinical trial, randomized, open with two arms

Countries of recruitment

Brazil

Contacts

• Name: Thiago Daniele
• Affiliation: UFC- Universidade Federal do Ceará

• Name: Thiago Daniele
• Affiliation: UFC- Universidade Federal do Ceará

Key inclusion & exclusion criteria

Inclusion criteria: Know diagnosed type 2 diabetes for at least 6 months.
Men and Woman.
Aged between 40 and 60 years.
Sign the consent term.


Exclusion criteria: Shift workers
Drug abuse
Hospitalization (past 30 days)
Severe comorbities (renal or hepatic impairment, advanced neoplasia, severe heart failure, severe neurological disorder)

Age minimum: 40Y
Age maximum: 60Y
Gender: -

Health Condition(s) or Problem(s) studied

E00-E90

Type 2 diabetes, disorders of sleep, daytime sleepiness, depression, restless legs syndrome and sedentarism.
C18.452.394.750.149

Intervention(s)

The experimental group will receive the study treatment guidelines regarding sleep hygiene measures. These measures are absolutely not to do naps (can negotiate 15 to 30 minutes), avoiding caffeine, nicotine and alcohol, avoid heavy meals late in the day, avoid spicy foods (remember that chocolate has caffeine, sunbathe in the morning and evening, regular bedtime hours (from 22 to 23 hours), the room is for sleeping (not to watch TV, work, etc.). your room should be pleasant, moderately quiet and pleasant temperature. Will be carried aerobic exercise for fifty minutes three times a week for a period of twelve weeks. the control group did not receive such guidance. Twelve weeks after the first assessment, patients will be reassessed with the same measurements. a blood sample will be collected between 7 and 9 hours to determine biochemical and inflammatory mediators (interleukin-1, interleukin-6, C-reactive protein, TNF-alpha, visfatin).

Primary Outcome(s)

Evaluate sleep disturbances through the validation of questionnaires (Index of Pittsburgh sleep quality, the Epworth Sleepiness Scale, Questionnaire on Restless Legs, Berlin Questionnaire, the Beck Depression Inventory, quality of life questionnaire SF-36 Questionnaire level of physical activity-IPAC) used and some inflammatory parameters (interleukin-1, interleukin-6, C-reactive protein, TNF-alpha, visfatin). in patients with type 2 diabetes in both groups by ELISA biochemical methods.

Secondary Outcome(s)

Evaluate if anthropometrical measurements as:
Body-Mass Index (BMI): weight divided by height squared
Body-fat index (TCI): the circumference of the hips (cm) -18 / height x square root of time
Conicity index (CI): Waist circumference (m) / 0.109 x ROOT (body mass / height)
Waist / Hip: Waist circumference (cm) / hip circumference (cm).

Secondary ID(s)

031.04.09

Source(s) of Monetary Support

CAPES-Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brazil

Secondary Sponsor(s)

CIDH- Centro Integrado de Diabetes e Hipertensão - Brazil

UFC- Universidade Federal do Ceará - Brazil