Chronic Effects of Two Aerobic-training Models Performed in Water and on Dry Land in Patients With Type 2 Diabetes Mellitus (T2DM).

November 4, 2014 updated by: Rodrigo Sudatti Delevatti, Hospital de Clinicas de Porto Alegre
The aim of this study was to analyse the acute and chronic effects of two aerobic-training models performed in water and on dry land on cardiorespiratory, functional, metabolic, hormonal and quality-of-life parameters in patients with type 2 diabetes mellitus (T2DM).

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Rio Grande do Sil
      • Porto Alegre, Rio Grande do Sil, Brazil, 90690-200
        • Physical Education School of Federal University of Rio Grande do Sul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

The clinical diagnosis of type 2 diabetes mellitus. Not be performing regular and systematic physical exercise for at least three months.

Exclusion Criteria:

Uncontrolled hypertension. Autonomic neuropathy. Severe peripheral neuropathy. Proliferative diabetic retinopathy. Severe nonproliferative diabetic retinopathy. Uncompensated heart failure. Peripheral amputations. Chronic renal failure (GFR by MDRD <30). Muscle or joint injury that prevents physical exercises.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aquatic exercise

The aquatic aerobic training had a duration of 12 weeks and adopted the interval-training method, with intensities ranging between 85 and 100% of second ventilatory threshold (VT2) and total duration of 45 minute per session.

The sessions consisted of warm up, main part and calm down. The warm-up consisted of a walk in deep water at low intensity for three minutes. The main part was intended to aerobic training in deep water, in which subjects walked and / or ran, depending on your fitness level found in pre-training test. The calm down consisted of walking in deep water at low intensity for two minutes and stretching standardized, emphasizing the muscles worked in the main part of the session, with a total duration of approximately five minutes.

Experimental: Land exercise

The land aerobic training had a duration of 12 weeks and adopted the interval-training method, with intensities ranging between 85 and 100% of second ventilatory threshold (VT2) and total duration of 45 minute per session.

The sessions consisted of warm up, main part and calm down. The warm-up consisted of a walk in athletic track at low intensity for three minutes. The main part was intended to aerobic training in athletic track, in which subjects walked and / or ran, depending on your fitness level found in pre-training test. The calm down consisted of walking in athletic track at low intensity for two minutes and stretching standardized, emphasizing the muscles worked in the main part of the session, with a total duration of approximately five minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycated hemoglobin
Time Frame: Baseline and after 12 weeks of intervention
Baseline and after 12 weeks of intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Fasting plasma glucose.
Time Frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Postprandial glucose
Time Frame: Baseline and after 12 weeks of intervention.
Baseline and after 12 weeks of intervention.
Fasting insulin.
Time Frame: Baseline and after 12 weeks of intervention.
Baseline and after 12 weeks of intervention.
Insulin resistance (HOMA-IR).
Time Frame: Baseline and after 12 weeks of intervention.
Baseline and after 12 weeks of intervention.
Total cholesterol.
Time Frame: Baseline and after 12 weeks of intervention.
Baseline and after 12 weeks of intervention.
High density lipoprotein.
Time Frame: Baseline and after 12 weeks of intervention.
Baseline and after 12 weeks of intervention.
Low density lipoprotein.
Time Frame: Baseline and after 12 weeks of intervention.
Baseline and after 12 weeks of intervention.
Triglycerides.
Time Frame: Baseline and after 12 weeks of intervention.
Baseline and after 12 weeks of intervention.
Plasma renin activity.
Time Frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Angiotensin II.
Time Frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
C-reactive protein ultrasensitive.
Time Frame: Baseline and after 12 weeks of intervention.
Baseline and after 12 weeks of intervention.
8-isoprostane
Time Frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Content of reative species (DCF)
Time Frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Water-soluble Fluorescent Substances
Time Frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Oxidation of tyrosine residues
Time Frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Oxidation of tryptophan
Time Frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
superoxide dismutase (SOD)
Time Frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Catalase (CAT)
Time Frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Glutathione peroxidase (GPX)
Time Frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Total radical-trapping antioxidant potential (TRAP)
Time Frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Interleukin 1β
Time Frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Interleukin 10
Time Frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Leukocyte DNA Methylation
Time Frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Purines
Time Frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Interleukin 6
Time Frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Global Histone Deacetylases activity
Time Frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.

Other Outcome Measures

Outcome Measure
Time Frame
Peak oxygen consumption.
Time Frame: Baseline and after 12 weeks of intervention.
Baseline and after 12 weeks of intervention.
Timed up and go in habitual speed and maximal speed.
Time Frame: Baseline and after 12 weeks of intervention.
Baseline and after 12 weeks of intervention.
Oxygen uptake at ventilatory threshold.
Time Frame: Baseline and after 12 weeks of intervention.
Baseline and after 12 weeks of intervention.
Percentage of oxygen consumption at ventilatory threshold.
Time Frame: Baseline and after 12 weeks of intervention.
Baseline and after 12 weeks of intervention.
Systolic blood pressure.
Time Frame: Baseline and after 12 weeks of intervention.
Baseline and after 12 weeks of intervention.
Diastolic blood pressure
Time Frame: Baseline and after 12 weeks of intervention.
Baseline and after 12 weeks of intervention.
Resting heart rate.
Time Frame: Baseline and after 12 weeks of intervention.
Baseline and after 12 weeks of intervention.
Quality of life.
Time Frame: Baseline and after 12 weeks of intervention.
Baseline and after 12 weeks of intervention.
Depressive symptoms.
Time Frame: Baseline and after 12 weeks of intervention.
Baseline and after 12 weeks of intervention.
Sleep quality.
Time Frame: Baseline and after 12 weeks of intervention.
Baseline and after 12 weeks of intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rodrigo S Delevatti, MSc, Hospital De Clinicas De Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

September 27, 2013

First Submitted That Met QC Criteria

October 6, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Estimate)

November 5, 2014

Last Update Submitted That Met QC Criteria

November 4, 2014

Last Verified

May 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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