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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
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 11, 2015
    Last Updated
    August 15, 2016
    Sponsor
    Hospital de Clinicas de Porto Alegre
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    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

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    The Diabetes and Aquatic Training Study (DATS)

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