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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Aquatic exercise
Land Exercise
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring aquatic exercises;, deep water running;, diabetes;, blood glucose;, inflammation.

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Physical Education School of Federal University of Rio Grande do Sul

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Aquatic exercise

Land exercise

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Glycated hemoglobin

Secondary Outcome Measures

Fasting plasma glucose.
Postprandial glucose
Fasting insulin.
Insulin resistance (HOMA-IR).
Total cholesterol.
High density lipoprotein.
Low density lipoprotein.
Triglycerides.
Plasma renin activity.
Angiotensin II.
C-reactive protein ultrasensitive.
8-isoprostane
Content of reative species (DCF)
Water-soluble Fluorescent Substances
Oxidation of tyrosine residues
Oxidation of tryptophan
superoxide dismutase (SOD)
Catalase (CAT)
Glutathione peroxidase (GPX)
Total radical-trapping antioxidant potential (TRAP)
Interleukin 1β
Interleukin 10
Leukocyte DNA Methylation
Purines
Interleukin 6
Global Histone Deacetylases activity

Full Information

First Posted
September 27, 2013
Last Updated
November 4, 2014
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT01956357
Brief Title
Chronic Effects of Two Aerobic-training Models Performed in Water and on Dry Land in Patients With Type 2 Diabetes Mellitus (T2DM).
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
aquatic exercises;, deep water running;, diabetes;, blood glucose;, inflammation.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aquatic exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Land exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Aquatic exercise
Intervention Type
Other
Intervention Name(s)
Land Exercise
Primary Outcome Measure Information:
Title
Glycated hemoglobin
Time Frame
Baseline and after 12 weeks of intervention
Secondary Outcome Measure Information:
Title
Fasting plasma glucose.
Time Frame
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Title
Postprandial glucose
Time Frame
Baseline and after 12 weeks of intervention.
Title
Fasting insulin.
Time Frame
Baseline and after 12 weeks of intervention.
Title
Insulin resistance (HOMA-IR).
Time Frame
Baseline and after 12 weeks of intervention.
Title
Total cholesterol.
Time Frame
Baseline and after 12 weeks of intervention.
Title
High density lipoprotein.
Time Frame
Baseline and after 12 weeks of intervention.
Title
Low density lipoprotein.
Time Frame
Baseline and after 12 weeks of intervention.
Title
Triglycerides.
Time Frame
Baseline and after 12 weeks of intervention.
Title
Plasma renin activity.
Time Frame
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Title
Angiotensin II.
Time Frame
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Title
C-reactive protein ultrasensitive.
Time Frame
Baseline and after 12 weeks of intervention.
Title
8-isoprostane
Time Frame
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Title
Content of reative species (DCF)
Time Frame
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Title
Water-soluble Fluorescent Substances
Time Frame
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Title
Oxidation of tyrosine residues
Time Frame
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Title
Oxidation of tryptophan
Time Frame
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Title
superoxide dismutase (SOD)
Time Frame
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Title
Catalase (CAT)
Time Frame
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Title
Glutathione peroxidase (GPX)
Time Frame
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Title
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.
Title
Interleukin 1β
Time Frame
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Title
Interleukin 10
Time Frame
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Title
Leukocyte DNA Methylation
Time Frame
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Title
Purines
Time Frame
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Title
Interleukin 6
Time Frame
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Title
Global Histone Deacetylases activity
Time Frame
Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Other Pre-specified Outcome Measures:
Title
Peak oxygen consumption.
Time Frame
Baseline and after 12 weeks of intervention.
Title
Timed up and go in habitual speed and maximal speed.
Time Frame
Baseline and after 12 weeks of intervention.
Title
Oxygen uptake at ventilatory threshold.
Time Frame
Baseline and after 12 weeks of intervention.
Title
Percentage of oxygen consumption at ventilatory threshold.
Time Frame
Baseline and after 12 weeks of intervention.
Title
Systolic blood pressure.
Time Frame
Baseline and after 12 weeks of intervention.
Title
Diastolic blood pressure
Time Frame
Baseline and after 12 weeks of intervention.
Title
Resting heart rate.
Time Frame
Baseline and after 12 weeks of intervention.
Title
Quality of life.
Time Frame
Baseline and after 12 weeks of intervention.
Title
Depressive symptoms.
Time Frame
Baseline and after 12 weeks of intervention.
Title
Sleep quality.
Time Frame
Baseline and after 12 weeks of intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo S Delevatti, MSc
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical Education School of Federal University of Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande do Sil
ZIP/Postal Code
90690-200
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
28935128
Citation
S Delevatti R, Schuch FB, Kanitz AC, Alberton CL, Marson EC, Lisboa SC, Pinho CDF, Bregagnol LP, Becker MT, Kruel LFM. Quality of life and sleep quality are similarly improved after aquatic or dry-land aerobic training in patients with type 2 diabetes: A randomized clinical trial. J Sci Med Sport. 2018 May;21(5):483-488. doi: 10.1016/j.jsams.2017.08.024. Epub 2017 Sep 6.
Results Reference
derived
PubMed Identifier
27502804
Citation
Delevatti RS, Pinho CD, Kanitz AC, Alberton CL, Marson EC, Bregagnol LP, Lisboa SC, Schaan BD, Kruel LF. Glycemic reductions following water- and land-based exercise in patients with type 2 diabetes mellitus. Complement Ther Clin Pract. 2016 Aug;24:73-7. doi: 10.1016/j.ctcp.2016.05.008. Epub 2016 May 10.
Results Reference
derived

Learn more about this trial

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

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