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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: aquatic exercises;
deep water running;
diabetes;
blood glucose;
inflammation.
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 35
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Glycated hemoglobin
timeFrame: Baseline and after 12 weeks of intervention
Secondary outcomes:
measure: Fasting plasma glucose.
timeFrame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
measure: Postprandial glucose
timeFrame: Baseline and after 12 weeks of intervention.
measure: Fasting insulin.
timeFrame: Baseline and after 12 weeks of intervention.
measure: Insulin resistance (HOMA-IR).
timeFrame: Baseline and after 12 weeks of intervention.
measure: Total cholesterol.
timeFrame: Baseline and after 12 weeks of intervention.
measure: High density lipoprotein.
timeFrame: Baseline and after 12 weeks of intervention.
measure: Low density lipoprotein.
timeFrame: Baseline and after 12 weeks of intervention.
measure: Triglycerides.
timeFrame: Baseline and after 12 weeks of intervention.
measure: Plasma renin activity.
timeFrame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
measure: Angiotensin II.
timeFrame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
measure: C-reactive protein ultrasensitive.
timeFrame: Baseline and after 12 weeks of intervention.
measure: 8-isoprostane
timeFrame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
measure: Content of reative species (DCF)
timeFrame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
measure: Water-soluble Fluorescent Substances
timeFrame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
measure: Oxidation of tyrosine residues
timeFrame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
measure: Oxidation of tryptophan
timeFrame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
measure: superoxide dismutase (SOD)
timeFrame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
measure: Catalase (CAT)
timeFrame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
measure: Glutathione peroxidase (GPX)
timeFrame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
measure: Total radical-trapping antioxidant potential (TRAP)
timeFrame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
measure: Interleukin 1β
timeFrame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
measure: Interleukin 10
timeFrame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
measure: Leukocyte DNA Methylation
timeFrame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
measure: Purines
timeFrame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
measure: Interleukin 6
timeFrame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
measure: Global Histone Deacetylases activity
timeFrame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Other outcomes:
measure: Peak oxygen consumption.
timeFrame: Baseline and after 12 weeks of intervention.
measure: Timed up and go in habitual speed and maximal speed.
timeFrame: Baseline and after 12 weeks of intervention.
measure: Oxygen uptake at ventilatory threshold.
timeFrame: Baseline and after 12 weeks of intervention.
measure: Percentage of oxygen consumption at ventilatory threshold.
timeFrame: Baseline and after 12 weeks of intervention.
measure: Systolic blood pressure.
timeFrame: Baseline and after 12 weeks of intervention.
measure: Diastolic blood pressure
timeFrame: Baseline and after 12 weeks of intervention.
measure: Resting heart rate.
timeFrame: Baseline and after 12 weeks of intervention.
measure: Quality of life.
timeFrame: Baseline and after 12 weeks of intervention.
measure: Depressive symptoms.
timeFrame: Baseline and after 12 weeks of intervention.
measure: Sleep quality.
timeFrame: Baseline and after 12 weeks of intervention.
Locations:
city: Porto Alegre
country: Brazil
facility: Physical Education School of Federal University of Rio Grande do Sul
state: Rio Grande do Sil
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Rodrigo S Delevatti, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.