Effects of a Physical Exercise Program Among Diabetic Women Users of the National Health System

Diabetes Mellitus Clinical Trial

Official title:

Effects of a Physical Exercise Program Among Diabetic Women Users of the National Health System: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03221868
• Other study ID #: diabetes7005
• Status: Completed
• Phase: N/A
• First received: December 27, 2016
• Last updated: August 25, 2017
• Start date: August 2016
• Est. completion date: July 2017

Study information

• Verified date: August 2017
• Source: Federal University of Pelotas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• females;

• type 2 diabetic;

• diagnosed for more than one year;

• BMI =25 kg / m²;

• age between 40 and 60 years.

Exclusion Criteria:

• BMI = 40 kg / m²;

• history of stroke;

• neuropathy or severe retinopathy;

• any serious medical condition that prevents the participant to exercise safely;

• history of severe physical disability

• history of acute myocardial infarction in the last six months.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Exercise group
An exercise-based program following a 12-week periodization using mostly circuit-like activities.
• Control group
Counseling to practice physical activity and meetings every 15 days with women to conduct group walks. Booklet with walking schedule and for registering sessions.

Locations

Country	Name	City	State
Brazil	Physical Education School of the Federal University of Pelotas	Pelotas	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Pelotas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	- Glycated hemoglobin - %	Measured at baseline, and the end of intervention, 12th week
Secondary	Change in Glucose	Fasting glucose - mg/dl	Measured at baseline, and the end of intervention, 12th week
Secondary	Change in Insulin	Fasting insulin - µI/ml	Measured at baseline, and the end of intervention, 12th week
Secondary	Change in BP	- Blood pressure - mm/hg measured with an automated equipment;	Measured at baseline, and the end of intervention, 12th week
Secondary	Change in Insulin resistance	Insulin resistance - Insulin (µI/L) X Fasting Glycemia (mg/dl)/405	Measured at baseline, and the end of intervention, 12th week
Secondary	Change in Triglycerides	Triglycerides - mg/dl	Measured at baseline, and the end of intervention, 12th week
Secondary	Change in Cholesterol	Total cholesterol and subfractions - mg/dl	Measured at baseline, and the end of intervention, 12th week
Secondary	Change in CRP	C-reactive protein - mg/l	Measured at baseline, and the end of intervention, 12th week
Secondary	Change in CRF	- Cardiorespiratory fitness - calculated based on the distance covered during the 6-minute walking test;	Measured at baseline, and the end of intervention, 12th week
Secondary	Change in LLS	- Lower limb strength - number of repetitions performed during the 30-Second Chair Stand Test;	Measured at baseline, and the end of intervention, 12th week
Secondary	Change in QoL	- Quality of life (SF-36) - sum of the scores of the scale.	Measured at baseline, and the end of intervention, 12th week