The Diabetes and Aquatic Training Study (DATS) (DATS)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aerobic training
Combined training
Training placebo
Sponsored by

About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Aerobic training group
Combined training group
Training placebo
Arm Description
This group perform aerobic hydrogymnastics.
This group perform combined hydrogymnastics.
This group perform stretching and relaxation in aquatic environment.
Outcomes
Primary Outcome Measures
Changes in levels of glycated hemoglobin
Secondary Outcome Measures
Fasting plasma glucose.
Fasting insulin.
Insulin-resistance index (HOMA-IR).
Total cholesterol.
high density lipoprotein.
Low density lipoprotein.
Triglycerides.
Renin
High sensitive C-reactive protein.
Total testosterone.
Cortisol
Testosterone/cortisol ratio.
Peak oxygen uptake.
Oxygen uptake at the second ventilatory threshold.
Percentage of oxygen consumption in the second ventilatory threshold from the peak oxygen uptake.
Systolic blood pressure.
Diastolic blood pressure
Heart rate at rest.
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.
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.
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.
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.
Timed up and go test performed at the usual speed.
Timed up and go test performed at the maximal speed.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02612805
First Posted
November 11, 2015
Last Updated
August 15, 2016
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT02612805
Brief Title
The Diabetes and Aquatic Training Study (DATS)
Acronym
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
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerobic training group
Arm Type
Experimental
Arm Description
This group perform aerobic hydrogymnastics.
Arm Title
Combined training group
Arm Type
Active Comparator
Arm Description
This group perform combined hydrogymnastics.
Arm Title
Training placebo
Arm Type
Placebo Comparator
Arm Description
This group perform stretching and relaxation in aquatic environment.
Intervention Type
Other
Intervention Name(s)
Aerobic training
Other Intervention Name(s)
Aquatic aerobic training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Combined training
Other Intervention Name(s)
Aquatic combined training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Training placebo
Other Intervention Name(s)
Control procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in levels of glycated hemoglobin
Time Frame
Change from Baseline levels of glycated hemoglobin at 15-weeks.
Secondary Outcome Measure Information:
Title
Fasting plasma glucose.
Time Frame
At baseline and after a 15-week period.
Title
Fasting insulin.
Time Frame
At baseline and after a 15-week period.
Title
Insulin-resistance index (HOMA-IR).
Time Frame
At baseline and after a 15-week period.
Title
Total cholesterol.
Time Frame
At baseline and after a 15-week period.
Title
high density lipoprotein.
Time Frame
At baseline and after a 15-week period.
Title
Low density lipoprotein.
Time Frame
At baseline and after a 15-week period.
Title
Triglycerides.
Time Frame
At baseline and after a 15-week period.
Title
Renin
Time Frame
At baseline and after a 15-week period.
Title
High sensitive C-reactive protein.
Time Frame
At baseline and after a 15-week period.
Title
Total testosterone.
Time Frame
At baseline and after a 15-week period.
Title
Cortisol
Time Frame
At baseline and after a 15-week period.
Title
Testosterone/cortisol ratio.
Time Frame
At baseline and after a 15-week period.
Title
Peak oxygen uptake.
Time Frame
At baseline and after a 15-week period.
Title
Oxygen uptake at the second ventilatory threshold.
Time Frame
At baseline and after a 15-week period.
Title
Percentage of oxygen consumption in the second ventilatory threshold from the peak oxygen uptake.
Time Frame
At baseline and after a 15-week period.
Title
Systolic blood pressure.
Time Frame
At baseline and after a 15-week period.
Title
Diastolic blood pressure
Time Frame
At baseline and after a 15-week period.
Title
Heart rate at rest.
Time Frame
At baseline and after a 15-week period.
Title
Maximum dynamic muscle strength (1RM) in the knees extension exercise.
Description
The test is characterized by greater load that can be supported in a single execution of knees extension exercise.
Time Frame
At baseline and after a 15-week period.
Title
Maximum dynamic muscle strength (1RM) in the elbows flexion exercise.
Description
The test is characterized by greater load that can be supported in a single execution of elbows flexion exercise.
Time Frame
At baseline and after a 15-week period.
Title
Resistant dynamic muscle strength (maximal repetitions) in the knees extension exercise.
Description
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.
Time Frame
At baseline and after a 15-week period.
Title
Resistant dynamic muscle strength (maximal repetitions) in the elbows flexion exercise.
Description
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.
Time Frame
At baseline and after a 15-week period.
Title
Timed up and go test performed at the usual speed.
Time Frame
At baseline and after a 15-week period.
Title
Timed up and go test performed at the maximal speed.
Time Frame
At baseline and after a 15-week period.
Title
Sitting-rising test (SRT).
Description
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.
Time Frame
At baseline and after a 15-week period.
Title
Overall quality of life and in physical, psychological, social relationships and environment domains, evaluated by instrument of World Health Organization (WHOQOL).
Description
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.
Time Frame
At baseline and after a 15-week period.
Title
Depressive symptoms, evaluated by Depression Inventory Patient Health Questionnarie (PHQ-9)
Description
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.
Time Frame
At baseline and after a 15-week period.
Title
Sleep quality, evaluated by Pittsburgh Sleep Scale
Description
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.
Time Frame
At baseline and after a 15-week period.
Title
Levels of sleep Obstructive Apnea, evaluated by Berlin Questionnaire (BQ)
Description
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.
Time Frame
At baseline and after a 15-week period.
Title
Physical activity levels, evaluated by International Physical Activity Questionnaire (IPAQ) - Short Form.
Description
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.
Time Frame
At baseline and after a 15-week period.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo Stein, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35902075
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.
Results Reference
derived
PubMed Identifier
32994381
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.
Results Reference
derived
Learn more about this trial
The Diabetes and Aquatic Training Study (DATS)
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