Clinical trial NCT02612805: The Diabetes and Aquatic Training Study (DATS)
Official title: Effects of Two Models of Physical Training in Aquatic Environment in Control of Type 2 Diabetes - A Controled Randomized Clinical Trial: The Diabetes and Aquatic Training Study (DATS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2015-11-24
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effects of the combined exercise training (aerobic more resistance) and of the aerobic exercise training isolated compared to control group, which performed only stretching and relaxation, in the treatment of type 2 diabetes (T2DM). The two exercise interventions and the control procedure are performed in aquatic environment.

Detailed description: The fact that aquatic training can provide similar benefits to land training has important clinical implications, because the aquatic environment provides some interesting advantages to this population, such as no impact on walking and running in deep water or reduced, as in water-based exercises. This minor impact and consequent reduced chance of injury allows consider the aquatic environment favorable to the principle of continuity with progression of physiological stimuli and metabolic benefits.

From these peculiarities of the training in aquatic environment, and of the association between T2DM with obesity and hypertension, conditions that create difficulties for individuals performing exercise supporting their own body mass and need both benefits from aerobic and resistance training, is believed to be necessary to carry out physical training programs of the same duration, differing in training mode (aerobic or combined) in the aquatic environment in order to answer of in a adequated duration of training, the diabetes control through training differs between the different mode of exercise.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes;
* Be under medical treatment with oral hypoglycemic agents and / or insulin;
* Not engaged in regular exercise (regular exercise was defined as performing any type of physical training for at least 20 minutes three or more days a week).

Exclusion Criteria:

* Severe autonomic neuropathy;
* Severe nonproliferative and proliferative diabetic retinopathy;
* Decompensated heart failure;
* Limb amputations;
* Severe foot injuries;
* Chronic renal failure (Modification Diet in Renal Disease-MDRD, Glomerular Filtration Rate-GFR \< 30 ml/min);
* Body mass index (BMI) \> 45.0 kg/m2;
* Any muscle or joint impairment which prevented individuals from engaging in physical exercise.

Primary outcomes:
measure: Changes in levels of glycated hemoglobin
timeFrame: Change from Baseline levels of glycated hemoglobin at 15-weeks.
Secondary outcomes:
measure: Fasting plasma glucose.
timeFrame: At baseline and after a 15-week period.
measure: Fasting insulin.
timeFrame: At baseline and after a 15-week period.
measure: Insulin-resistance index (HOMA-IR).
timeFrame: At baseline and after a 15-week period.
measure: Total cholesterol.
timeFrame: At baseline and after a 15-week period.
measure: high density lipoprotein.
timeFrame: At baseline and after a 15-week period.
measure: Low density lipoprotein.
timeFrame: At baseline and after a 15-week period.
measure: Triglycerides.
timeFrame: At baseline and after a 15-week period.
measure: Renin
timeFrame: At baseline and after a 15-week period.
measure: High sensitive C-reactive protein.
timeFrame: At baseline and after a 15-week period.
measure: Total testosterone.
timeFrame: At baseline and after a 15-week period.
measure: Cortisol
timeFrame: At baseline and after a 15-week period.
measure: Testosterone/cortisol ratio.
timeFrame: At baseline and after a 15-week period.
measure: Peak oxygen uptake.
timeFrame: At baseline and after a 15-week period.
measure: Oxygen uptake at the second ventilatory threshold.
timeFrame: At baseline and after a 15-week period.
measure: Percentage of oxygen consumption in the second ventilatory threshold from the peak oxygen uptake.
timeFrame: At baseline and after a 15-week period.
measure: Systolic blood pressure.
timeFrame: At baseline and after a 15-week period.
measure: Diastolic blood pressure
timeFrame: At baseline and after a 15-week period.
measure: Heart rate at rest.
timeFrame: At baseline and after a 15-week period.
measure: Maximum dynamic muscle strength (1RM) in the knees extension exercise.
timeFrame: At baseline and after a 15-week period.
measure: Maximum dynamic muscle strength (1RM) in the elbows flexion exercise.
timeFrame: At baseline and after a 15-week period.
measure: Resistant dynamic muscle strength (maximal repetitions) in the knees extension exercise.
timeFrame: At baseline and after a 15-week period.
measure: Resistant dynamic muscle strength (maximal repetitions) in the elbows flexion exercise.
timeFrame: At baseline and after a 15-week period.
measure: Timed up and go test performed at the usual speed.
timeFrame: At baseline and after a 15-week period.
measure: Timed up and go test performed at the maximal speed.
timeFrame: At baseline and after a 15-week period.
measure: Sitting-rising test (SRT).
timeFrame: At baseline and after a 15-week period.
measure: Overall quality of life and in physical, psychological, social relationships and environment domains, evaluated by instrument of World Health Organization (WHOQOL).
timeFrame: At baseline and after a 15-week period.
measure: Depressive symptoms, evaluated by Depression Inventory Patient Health Questionnarie (PHQ-9)
timeFrame: At baseline and after a 15-week period.
measure: Sleep quality, evaluated by Pittsburgh Sleep Scale
timeFrame: At baseline and after a 15-week period.
measure: Levels of sleep Obstructive Apnea, evaluated by Berlin Questionnaire (BQ)
timeFrame: At baseline and after a 15-week period.
measure: Physical activity levels, evaluated by International Physical Activity Questionnaire (IPAQ) - Short Form.
timeFrame: At baseline and after a 15-week period.
Other outcomes:
Locations:
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Ricardo Stein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Delevatti RS, Reichert T, Bracht CG, Lisboa SDC, Marson EC, Costa RR, Kanitz AC, Bones V, Stein R, Kruel LFM. Aquatic Aerobic and Combined Training in Management of Type 2 Diabetes: The Diabetes and Aquatic Training Study (DATS): A Randomized Clinical Trial. J Phys Act Health. 2022 Jul 28;19(8):578-587. doi: 10.1123/jpah.2022-0016. Print 2022 Aug 1.
citation: Delevatti RS, Kanitz AC, Bracht CG, Lisboa SDC, Marson EC, Reichert T, Bones V, Kruel LFM. Effects of 2 Models of Aquatic Exercise Training on Cardiorespiratory Responses of Patients With Type 2 Diabetes: The Diabetes and Aquatic Training Study-A Randomized Controlled Trial. J Phys Act Health. 2020 Sep 29;17(11):1091-1099. doi: 10.1123/jpah.2020-0236.