Effects of a Physical Exercise Program Among Diabetic Women Users of the National Health System
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      The study aims at evaluating the effects of an intervention among diabetic women (40 years or
      older) who belong to the Basic Health Units System (Brazilian public health system). The
      novelty of this project is that the intervention is low cost and demands very little from the
      health system in terms of structure, facilities and personnel.
    

Detailed description: 
      The objective of this project is to evaluate the effect of a physical exercise program on the
      biochemical profile of type 2 diabetic women users of Basic Health Units (BHU) in the urban
      area of the city of Pelotas (Brazil). This is a randomized clinical trial, where two BHU's of
      the 14 eligible for the study will be drawn for inclusion in the study. Only those units with
      more than 100 registered diabetic patients are eligible, they also are not linked to
      educational institutions and do not present Physical activity projects. Four Basic Health
      Units (BHU) of the municipality of Pelotas (Brazil) were randomized, two for the intervention
      group and two for the control group. The intervention group will perform circuit-like
      physical exercises three times a week and the control will receive counseling to practice
      physical activity and meetings every 15 days with the womens to carry out walks. The program
      lasted 12 weeks, with three weekly sessions and presented four distinct sequences containing
      10 exercises each, which were performed and circuit form and modified every three weeks. In
      the first week of the intervention, the women performed a passage in the circuit and with
      each new week a passage was increased, until the number of three passes was reached (number
      of passages kept fixed until the end of the intervention). Each exercise initially had a
      duration of 30 seconds, with a duration of 10 seconds added every three weeks up to a maximum
      of 60 seconds; The interval of 30 seconds between exercises was kept fixed throughout the
      intervention. The intensity was controlled by the subjective perception of effort. Mainly
      blood chemistry will be measured and evaluated.Possible confounding factors to be controlled:
      age, skin color, schooling, family income, weight, Body Mass Index (BMI), alcohol
      consumption, smoking, waist circumference, time to diagnose the disease, use of Medicines for
      diabetes and eating habits. The information will be collected at the baseline, at the eighth
      week and at the end of the study. Descriptive analyzes of the data will be performed
      initially, the associations will be tested by correlation, t-test and ANOVA for repeated
      measures. For comparisons of categorical variables, Chi-square tests will be used for
      heterogeneity or linear trend. The multivariate analysis will be run through logistic
      regression. The analyzes will be performed by intention to treat and by adherence, and the
      level of significance accepted for the study will be 5%. This study will seek to fill gaps in
      the knowledge about intervention studies in BHU's in order to identify whether physical
      exercise interventions with proper planning and orientation can promote improvements in the
      severity of the disease in diabetic women.
    

Intervention name(s): Exercise group; Control group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): An exercise-based program following a 12-week periodization using mostly circuit-like activities.; Counseling to practice physical activity and meetings every 15 days with women to conduct group walks. Booklet with walking schedule and for registering sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: motor activity; women