Diabetes Mellitus, Type 2DATSNCT02612805
The Diabetes and Aquatic Training Study (DATS)
A study testing Aerobic training and Combined training in people with Diabetes Mellitus, Type 2, run by Hospital de Clinicas de Porto Alegre.
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). Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Aerobic training and Combined training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
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)
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Aerobic training, Combined training, Training placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic trainingOther
Also called Aquatic 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 trainingOther
Also called Aquatic 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 placeboOther
Also called Control procedure
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic training group | Experimental | This group perform aerobic hydrogymnastics. Receives: Other: Aerobic training |
| Combined training group | Active comparator | This group perform combined hydrogymnastics. Receives: Other: Combined training |
| Training placebo | Placebo comparator | This group perform stretching and relaxation in aquatic environment. Receives: Other: Training placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in levels of glycated hemoglobin
Measured: Change from Baseline levels of glycated hemoglobin at 15-weeks.
Secondary outcomes (30)
Fasting plasma glucose.
Measured: At baseline and after a 15-week period.
Fasting insulin.
Measured: At baseline and after a 15-week period.
Insulin-resistance index (HOMA-IR).
Measured: At baseline and after a 15-week period.
Total cholesterol.
Measured: At baseline and after a 15-week period.
high density lipoprotein.
Measured: At baseline and after a 15-week period.
Low density lipoprotein.
Measured: At baseline and after a 15-week period.
Triglycerides.
Measured: At baseline and after a 15-week period.
Renin
Measured: At baseline and after a 15-week period.
High sensitive C-reactive protein.
Measured: At baseline and after a 15-week period.
Total testosterone.
Measured: At baseline and after a 15-week period.
Cortisol
Measured: At baseline and after a 15-week period.
Testosterone/cortisol ratio.
Measured: At baseline and after a 15-week period.
Peak oxygen uptake.
Measured: At baseline and after a 15-week period.
Oxygen uptake at the second ventilatory threshold.
Measured: At baseline and after a 15-week period.
Percentage of oxygen consumption in the second ventilatory threshold from the peak oxygen uptake.
Measured: At baseline and after a 15-week period.
Systolic blood pressure.
Measured: At baseline and after a 15-week period.
Diastolic blood pressure
Measured: At baseline and after a 15-week period.
Heart rate at rest.
Measured: At baseline and after a 15-week period.
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.
Measured: At baseline and after a 15-week period.
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.
Measured: At baseline and after a 15-week period.
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.
Measured: At baseline and after a 15-week period.
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.
Measured: At baseline and after a 15-week period.
Timed up and go test performed at the usual speed.
Measured: At baseline and after a 15-week period.
Timed up and go test performed at the maximal speed.
Measured: At baseline and after a 15-week period.
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.
Measured: At baseline and after a 15-week period.
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.
Measured: At baseline and after a 15-week period.
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.
Measured: At baseline and after a 15-week period.
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.
Measured: At baseline and after a 15-week period.
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.
Measured: At baseline and after a 15-week period.
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.
Measured: At baseline and after a 15-week period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo Stein, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02612805
- Sponsor's protocol ID
- 15-0380
- Acronym
- DATS
- Status last verified
- Aug 2016
- First submitted
- 11 Nov 2015
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35902075Delevatti 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.
PubMed 32994381
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02612805
- Acronym / sponsor ID
- DATS / 15-0380
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic training group | Experimental | Other: Aerobic trainingThis group perform aerobic hydrogymnastics. |
| Combined training group | Active comparator | Other: Combined trainingThis group perform combined hydrogymnastics. |
| Training placebo | Placebo comparator | Other: Training placeboThis group perform stretching and relaxation in aquatic environment. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (8 listed)
- Severe autonomic neuropathy;
- Severe nonproliferative and proliferative diabetic retinopathy;
- Decompensated heart failure;
- Limb amputations;
- Severe foot injuries;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic trainingAlso: Aquatic aerobic trainingTotal 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. | Other | Aerobic training group |
| Combined trainingAlso: Aquatic combined trainingTotal 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. | Other | Combined training group |
| Training placeboAlso: Control procedureTotal 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. | Other | Training placebo |
Primary outcome
Changes in levels of glycated hemoglobin
Time frame: Change from Baseline levels of glycated hemoglobin at 15-weeks.
30 secondary outcomes
Fasting plasma glucose.
Time frame: At baseline and after a 15-week period.
Fasting insulin.
Time frame: At baseline and after a 15-week period.
Insulin-resistance index (HOMA-IR).
Time frame: At baseline and after a 15-week period.
Total cholesterol.
Time frame: At baseline and after a 15-week period.
high density lipoprotein.
Time frame: At baseline and after a 15-week period.
Low density lipoprotein.
Time frame: At baseline and after a 15-week period.
Triglycerides.
Time frame: At baseline and after a 15-week period.
Renin
Time frame: At baseline and after a 15-week period.
High sensitive C-reactive protein.
Time frame: At baseline and after a 15-week period.
Total testosterone.
Time frame: At baseline and after a 15-week period.
Cortisol
Time frame: At baseline and after a 15-week period.
Testosterone/cortisol ratio.
Time frame: At baseline and after a 15-week period.
Peak oxygen uptake.
Time frame: At baseline and after a 15-week period.
Oxygen uptake at the second ventilatory threshold.
Time frame: At baseline and after a 15-week period.
Percentage of oxygen consumption in the second ventilatory threshold from the peak oxygen uptake.
Time frame: At baseline and after a 15-week period.
Systolic blood pressure.
Time frame: At baseline and after a 15-week period.
Diastolic blood pressure
Time frame: At baseline and after a 15-week period.
Heart rate at rest.
Time frame: At baseline and after a 15-week period.
Maximum dynamic muscle strength (1RM) in the knees extension exercise.
Time frame: At baseline and after a 15-week period.
Maximum dynamic muscle strength (1RM) in the elbows flexion exercise.
Time frame: At baseline and after a 15-week period.
Resistant dynamic muscle strength (maximal repetitions) in the knees extension exercise.
Time frame: At baseline and after a 15-week period.
Resistant dynamic muscle strength (maximal repetitions) in the elbows flexion exercise.
Time frame: At baseline and after a 15-week period.
Timed up and go test performed at the usual speed.
Time frame: At baseline and after a 15-week period.
Timed up and go test performed at the maximal speed.
Time frame: At baseline and after a 15-week period.
Sitting-rising test (SRT).
Time frame: At baseline and after a 15-week period.
Overall quality of life and in physical, psychological, social relationships and environment domains, evaluated by instrument of World Health Organization (WHOQOL).
Time frame: At baseline and after a 15-week period.
Depressive symptoms, evaluated by Depression Inventory Patient Health Questionnarie (PHQ-9)
Time frame: At baseline and after a 15-week period.
Sleep quality, evaluated by Pittsburgh Sleep Scale
Time frame: At baseline and after a 15-week period.
Levels of sleep Obstructive Apnea, evaluated by Berlin Questionnaire (BQ)
Time frame: At baseline and after a 15-week period.
Physical activity levels, evaluated by International Physical Activity Questionnaire (IPAQ) - Short Form.
Time frame: At baseline and after a 15-week period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
- Derived from this study: PubMed 35902075Delevatti 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.
- Derived from this study: PubMed 32994381Delevatti 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Stein, PhD principal investigator
Hospital de Clinicas de Porto Alegre
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic training and Combined training in people with Diabetes Mellitus, Type 2, run by Hospital de Clinicas de Porto Alegre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in levels of glycated hemoglobin (time frame: Change from Baseline levels of glycated hemoglobin at 15-weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02612805, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016.