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Clinical Trials/NCT01956357
NCT01956357CompletedNot Applicable

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

Hospital de Clinicas de Porto Alegre2 sites in 1 country35 target enrollmentStarted: August 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
35
Locations
2
Primary Endpoint
Glycated hemoglobin

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
30 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Aquatic exercise

Experimental

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.

Intervention: Aquatic exercise (Other)

Land exercise

Experimental

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: Land Exercise (Other)

Outcomes

Primary Outcomes

Glycated hemoglobin

Time Frame: Baseline and after 12 weeks of intervention

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rodrigo Sudatti Delevatti

Effects of two models of aerobic training performed in different environments in patients with type 2 diabetes mellitus

Hospital de Clinicas de Porto Alegre

Study Sites (2)

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