- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01956357
Chronic Effects of Two Aerobic-training Models Performed in Water and on Dry Land in Patients With Type 2 Diabetes Mellitus (T2DM).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Rio Grande do Sil
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Porto Alegre, Rio Grande do Sil, Brazil, 90690-200
- Physical Education School of Federal University of Rio Grande do Sul
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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. |
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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.
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Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
|
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Postprandial glucose
Time Frame: Baseline and after 12 weeks of intervention.
|
Baseline and after 12 weeks of intervention.
|
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Fasting insulin.
Time Frame: Baseline and after 12 weeks of intervention.
|
Baseline and after 12 weeks of intervention.
|
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Insulin resistance (HOMA-IR).
Time Frame: Baseline and after 12 weeks of intervention.
|
Baseline and after 12 weeks of intervention.
|
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Total cholesterol.
Time Frame: Baseline and after 12 weeks of intervention.
|
Baseline and after 12 weeks of intervention.
|
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High density lipoprotein.
Time Frame: Baseline and after 12 weeks of intervention.
|
Baseline and after 12 weeks of intervention.
|
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Low density lipoprotein.
Time Frame: Baseline and after 12 weeks of intervention.
|
Baseline and after 12 weeks of intervention.
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Triglycerides.
Time Frame: Baseline and after 12 weeks of intervention.
|
Baseline and after 12 weeks of intervention.
|
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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.
|
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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.
|
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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.
|
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Water-soluble Fluorescent Substances
Time Frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
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Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
|
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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.
|
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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.
|
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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.
|
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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.
|
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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.
|
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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.
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Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
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Interleukin 1β
Time Frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
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Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
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Interleukin 10
Time Frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
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Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
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Leukocyte DNA Methylation
Time Frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
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Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
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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.
|
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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.
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Global Histone Deacetylases activity
Time Frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
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Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
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Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Peak oxygen consumption.
Time Frame: Baseline and after 12 weeks of intervention.
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Baseline and after 12 weeks of intervention.
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Timed up and go in habitual speed and maximal speed.
Time Frame: Baseline and after 12 weeks of intervention.
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Baseline and after 12 weeks of intervention.
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Oxygen uptake at ventilatory threshold.
Time Frame: Baseline and after 12 weeks of intervention.
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Baseline and after 12 weeks of intervention.
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Percentage of oxygen consumption at ventilatory threshold.
Time Frame: Baseline and after 12 weeks of intervention.
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Baseline and after 12 weeks of intervention.
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Systolic blood pressure.
Time Frame: Baseline and after 12 weeks of intervention.
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Baseline and after 12 weeks of intervention.
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Diastolic blood pressure
Time Frame: Baseline and after 12 weeks of intervention.
|
Baseline and after 12 weeks of intervention.
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Resting heart rate.
Time Frame: Baseline and after 12 weeks of intervention.
|
Baseline and after 12 weeks of intervention.
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Quality of life.
Time Frame: Baseline and after 12 weeks of intervention.
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Baseline and after 12 weeks of intervention.
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Depressive symptoms.
Time Frame: Baseline and after 12 weeks of intervention.
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Baseline and after 12 weeks of intervention.
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Sleep quality.
Time Frame: Baseline and after 12 weeks of intervention.
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Baseline and after 12 weeks of intervention.
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Collaborators and Investigators
Investigators
- Principal Investigator: Rodrigo S Delevatti, MSc, Hospital De Clinicas De Porto Alegre
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 54475
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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