The Diabetes and Aquatic Training Study (DATS)

Diabetes Mellitus, Type 2 Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612805
• Other study ID #: 15-0380
• Status: Completed
• Phase: N/A
• First received: November 11, 2015
• Last updated: August 15, 2016
• Start date: November 2015
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Aerobic training
Total duration of exercise sessions: 56 minutes (3 minutes of warming - 50 minutes of main part - 3 minutes of stretching); Method of training: Aerobic continuous in aquatic environment; Modality: Hydrogymnastics; Weekly frequency: 3; Intensity: 85% to 100% of the anaerobic threshold during the intervention.
• Combined training
Total duration of exercise sessions: 56 minutes (3 minutes of warming - 50 minutes of main part - 3 minutes of stretching); Method of training: Aerobic more resistance training. Aerobic component (between 30 and 40 minutes of the sessions): Method: Aerobic continuous in aquatic environment; Modality: Hydrogymnastics; Weekly frequency: 3; Intensity: 85% to 100% of the anaerobic threshold during the intervention. Resistance component (Between 10 and 20 minutes of the sessions): Method: Multiple sets (2 to 4 sets of 30 to 15 seconds) in aquatic environment; Modality: Hydrogymnastics; Weekly frequency: 3; Intensity: Maximum execution speed.
• Training placebo
Total duration of exercise sessions: 56 minutes (3 minutes of warming - 50 minutes of main part - 3 minutes of stretching); Activities performed in main part: Stretching and relaxation in aquatic environment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in levels of glycated hemoglobin		Change from Baseline levels of glycated hemoglobin at 15-weeks.	No
Secondary	Fasting plasma glucose.		At baseline and after a 15-week period.	No
Secondary	Fasting insulin.		At baseline and after a 15-week period.	No
Secondary	Insulin-resistance index (HOMA-IR).		At baseline and after a 15-week period.	No
Secondary	Total cholesterol.		At baseline and after a 15-week period.	No
Secondary	high density lipoprotein.		At baseline and after a 15-week period.	No
Secondary	Low density lipoprotein.		At baseline and after a 15-week period.	No
Secondary	Triglycerides.		At baseline and after a 15-week period.	No
Secondary	Renin		At baseline and after a 15-week period.	No
Secondary	High sensitive C-reactive protein.		At baseline and after a 15-week period.	No
Secondary	Total testosterone.		At baseline and after a 15-week period.	No
Secondary	Cortisol		At baseline and after a 15-week period.	No
Secondary	Testosterone/cortisol ratio.		At baseline and after a 15-week period.	No
Secondary	Peak oxygen uptake.		At baseline and after a 15-week period.	No
Secondary	Oxygen uptake at the second ventilatory threshold.		At baseline and after a 15-week period.	No
Secondary	Percentage of oxygen consumption in the second ventilatory threshold from the peak oxygen uptake.		At baseline and after a 15-week period.	No
Secondary	Systolic blood pressure.		At baseline and after a 15-week period.	No
Secondary	Diastolic blood pressure		At baseline and after a 15-week period.	No
Secondary	Heart rate at rest.		At baseline and after a 15-week period.	No
Secondary	Maximum dynamic muscle strength (1RM) in the knees extension exercise.	The test is characterized by greater load that can be supported in a single execution of knees extension exercise.	At baseline and after a 15-week period.	No
Secondary	Maximum dynamic muscle strength (1RM) in the elbows flexion exercise.	The test is characterized by greater load that can be supported in a single execution of elbows flexion exercise.	At baseline and after a 15-week period.	No
Secondary	Resistant dynamic muscle strength (maximal repetitions) in the knees extension exercise.	To determine the resistant dynamic muscle strength, it was considered the number of repetitions performed at 60% of 1RM, following a pace and breadth of pre-established execution. In the post-training evaluation, we used the load of 60% of 1RM test performed in the pre-training.	At baseline and after a 15-week period.	No
Secondary	Resistant dynamic muscle strength (maximal repetitions) in the elbows flexion exercise.	To determine the resistant dynamic muscle strength, it was considered the number of repetitions performed at 60% of 1RM, following a pace and breadth of pre-established execution. In the post-training evaluation, we used the load of 60% of 1RM test performed in the pre-training.	At baseline and after a 15-week period.	No
Secondary	Timed up and go test performed at the usual speed.		At baseline and after a 15-week period.	No
Secondary	Timed up and go test performed at the maximal speed.		At baseline and after a 15-week period.	No
Secondary	Sitting-rising test (SRT).	The SRT basically consists in the quantification of the number of support (hands and/or knees, or hands or forearms on knees) one utilizes in order to sit and to rise from the floor.	At baseline and after a 15-week period.	No
Secondary	Overall quality of life and in physical, psychological, social relationships and environment domains, evaluated by instrument of World Health Organization (WHOQOL).	To evaluate the quality of life we used the WHOQOL-brief instrument. This instrument is self-applicable, cross-cultural, translated and validated for Portuguese, consisting of 26 questions. Its score ranges from zero to 100 points, divided into the physical, psychological, social relationships and environment, as well as an assessment of the overall quality of life.	At baseline and after a 15-week period.	No
Secondary	Depressive symptoms, evaluated by Depression Inventory Patient Health Questionnarie (PHQ-9)	For evaluation of depressive symptoms was used the questionnaire PHQ-9 depression, which consists of nine items, including symptoms and attitudes whose intensity varies from zero to three, with 27 your score.	At baseline and after a 15-week period.	No
Secondary	Sleep quality, evaluated by Pittsburgh Sleep Scale	Sleep quality was assessed by Pittsburgh scale, consisting of 19 questions on the perception of oneself and five questions relating to the perception that the roommates of these individuals have about sleep the same. These questions are grouped into seven components, with score of zero to three.	At baseline and after a 15-week period.	No
Secondary	Levels of sleep Obstructive Apnea, evaluated by Berlin Questionnaire (BQ)	This questionnaire includes 10 items, organized in 3 categories related to snoring and apneas witnessed (5 items), daytime sleepiness (4 items) and high blood pressure (HTA) / obesity (1 item). Information on gender, age, height, weight, race neck circumference and is also requested. The determination of high or low risk to OSAS is based on responses in each category itens.	At baseline and after a 15-week period.	No
Secondary	Physical activity levels, evaluated by International Physical Activity Questionnaire (IPAQ) - Short Form.	The IPAQ short form asks about three specific types of activity undertaken in the three domains introduced above and sitting. The specific types of activity that are assessed are walking, moderate-intensity activities and vigorous intensity activities; frequency (measured in days per week) and duration (time per day) are collected separately for each specific type of activity.	At baseline and after a 15-week period.	No