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

NCT03221868 | Completed

• 1 other identifier: diabetes7005
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus

Keywords

motor activity; women

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  \- Glycated hemoglobin - %

  Measured at baseline, and the end of intervention, 12th week

Secondary Outcomes (10)

• Change in Glucose

  Measured at baseline, and the end of intervention, 12th week

• Change in Insulin

  Measured at baseline, and the end of intervention, 12th week

• Change in BP

  Measured at baseline, and the end of intervention, 12th week

• Change in Insulin resistance

  Measured at baseline, and the end of intervention, 12th week

• Change in Triglycerides

  Measured at baseline, and the end of intervention, 12th week

Study Arms (2)

Physical exercise intervention

EXPERIMENTAL

Exercise group. Physical exercise intervention with sessions carried out as circuit-training, three times a week for 12 weeks to improve physical fitness and metabolic control. The sessions will last between 10 and 45 minutes.

Behavioral: Exercise group

Control

ACTIVE COMPARATOR

Control group consisting of women who underwent the same measurements for future comparisons and were assigned to receive information about health and counseling to practice of physical activity.

Behavioral: Control group

Interventions

Exercise group BEHAVIORAL

An exercise-based program following a 12-week periodization using mostly circuit-like activities.

Physical exercise intervention

Control group BEHAVIORAL

Counseling to practice physical activity and meetings every 15 days with women to conduct group walks. Booklet with walking schedule and for registering sessions.

Control

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• females;
• type 2 diabetic;
• diagnosed for more than one year;
• BMI ≥25 kg / m²;
• age between 40 and 60 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Pelotas: lead

Study Sites (1)

Physical Education School of the Federal University of Pelotas

Pelotas, Rio Grande do Sul, 96055-630, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• MARLOS R DOMINGUES, PhD

  Postgraduate Program in Physical Education, Federal University of Pelotas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 27, 2016
• First Posted: July 19, 2017
• Study Start: August 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 28, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)