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Progressive vs. Non-progressive Water-based Aerobic Training on Type 2 Diabetes Control: a Randomized Clinical Trial (PAT-DM2)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Progressive water-based aerobic training
Non-progressive aerobic training
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Exercise, Water-based exercise, Aerobic exercise, Glucose control, Type 2 diabetes

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Individuals with type 2 diabetes, of both sexes, aged between 40 and 70 years.
  • Be under medical treatment with oral hypoglycemic agents and / or insulin;
  • Not be 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:

  • Presence of:
  • uncontrolled hypertension;
  • autonomic neuropathy;
  • severe peripheral neuropathy;
  • proliferative diabetic retinopathy;
  • severe non-proliferative diabetic retinopathy;
  • uncompensated heart failure;
  • peripheral amputations;
  • chronic kidney failure;
  • body mass index (BMI)> 45.0 kg/m2;
  • to have some muscle or joint impairment that prevents the performance of physical exercises safely.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Progressive aerobic training

    Non-progressive aerobic training

    Arm Description

    Water-based aerobic training performed with progression in the training variables. The intervention will be performed during 12 weeks, with 3 weekly sessions (of 50 minutes each), of walking/running in shallow pool.

    Water-based aerobic training performed without progression in the training variables. The intervention will be performed during 12 weeks, with 3 weekly sessions (of 50 minutes each), of walking/running in shallow pool.

    Outcomes

    Primary Outcome Measures

    Glycated Hemoglobin levels (HbA1c)
    Blood samples will be used to analyze glycated hemoglobin levels (%)

    Secondary Outcome Measures

    Fasting plasma glucose
    in mg/dL
    Fasting insulin
    in mg/dL
    Insulin-resistance index (HOMA-IR)
    in amount
    Total cholesterol
    in mg/dL
    High density lipoprotein
    in mg/dL
    Low density lipoprotein
    in mg/dL
    Triglycerides
    in mg/dL
    Plasma renin
    in uIU/mL (microliter)
    C-reactive protein
    in mg/L
    Peak oxygen uptake
    in ml.kg.min-1
    Oxygen uptake at the second ventilatory threshold.
    in ml.kg.min-1
    Percentage of oxygen consumption in the second ventilatory threshold from the peak oxygen uptake
    in %
    Systolic blood pressure.
    in mmHg
    Diastolic blood pressure.
    in mmHg
    Resting heart rate
    in beats per minute
    Maximum dynamic muscle strength (1RM) in the knees extension exercise
    The test is characterized by greatest load that can be supported in a single execution of knees extension exercise.
    Muscular resistance (maximal repetitions) in the knees extension exercise.
    To determine muscular resistance, it will be considered the number of repetitions performed at 60% of 1RM, following a paced pre-established execution. In the post-training evaluation, we will use the load of 60% of 1RM test performed in the pre-training.
    Timed up-and-go test performed at the usual speed.
    In seconds
    Timed up-and-go test performed at the maximal speed.
    In seconds
    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 Questionnaire (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 being the higher 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.
    Physical activity levels, evaluated by International Physical Activity Questionnaire (IPAQ) - Long Form.
    The IPAQ asks about three specific types of activity undertaken in the three domains introduced above and sitting time. 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
    May 27, 2019
    Last Updated
    June 2, 2019
    Sponsor
    Federal University of Rio Grande do Sul
    Collaborators
    Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03967561
    Brief Title
    Progressive vs. Non-progressive Water-based Aerobic Training on Type 2 Diabetes Control: a Randomized Clinical Trial
    Acronym
    PAT-DM2
    Official Title
    Effects of Progressive vs. Non-progressive Water-based Aerobic Training on Type 2 Diabetes Control: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 10, 2019 (Anticipated)
    Primary Completion Date
    October 30, 2019 (Anticipated)
    Study Completion Date
    November 15, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Rio Grande do Sul
    Collaborators
    Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This is a randomized clinical trial with the aim to evaluate the effects of two water-based aerobic training programs (walking or running in shallow pool) on type 2 diabetes control. The sample will be composed by 50 individuals with type 2 diabetes, of both sexes, aged between 40 and 70 years, who will be randomized into water-based progressive aerobic training (PAT, n=25) and water-based non-progressive aerobic training (NPAT, n=25). Both trainings will have 12 weeks of duration with 3 weekly sessions (of 50 minutes each). Biochemical, cardiorespiratory fitness, maximum strength, body composition and functional mobility variables, as also quality of life, sleep quality and depressive symptoms will be analyzed before and after the 12 weeks of training.
    Detailed Description
    Water-based aerobic training can provide benefits with important clinical implications for type 2 diabetes (T2D) patients, as the aquatic environment provides some interesting advantages to this population. The lower impact on joints and consequent reduced chance of injury allows considering the aquatic environment favorable to the principle of continuity with progression of physiological stimuli and metabolic benefits. In T2D individuals, studies have been analyzing the effects of water-based aerobic training in upright position, which have been promoting several results in metabolic parameters of T2D individuals, including benefits in glucose and lipids levels and in cardiorespiratory fitness. The literature shows distinct exercise effects on glucose control of T2D patients, resulting from different forms of training structuring, with and without progression of training variables. Well-conducted clinical trials prescribing aerobic training according to American Diabetes Association (ADA) recommendations (i.e. structured aerobic training with weekly duration of at least 150 minutes of moderate to vigorous intensity performed in three or more sessions per week) but with minimal or without progression in training load found no HbA1c reductions, whereas some studies that did not meet the recommendations but progressed training volume and/or intensity over time found interesting HbA1c reductions. With these findings, it seems that the optimization of aerobic training benefits on glucose control may not solely depend on a fixed training dosage, but also on the progression of the volume and/or intensity of training. Due to the associations between T2D with obesity and hypertension, conditions that create difficulties for individuals performing exercise while supporting their own body mass, the different responses arising from the studies investigating progressive and non-progressive aerobic trainings in T2D patients, and with the important facilities that the aquatic environment can promote during physical exercise performance, it becomes interesting to investigate the effects of the application of two aquatic aerobic trainings on T2D treatment, in which similar exercise programs are performed, with one of them having its training variables fixed over time (non-progressive training) and the other with progression in the variables (progressive training). To the present moment, no clinical trial has investigated the comparison between aquatic aerobic training interventions with and without progression in the training variables on glycemic control of T2D individuals, aiming at exploring the role of training progression. For this purpose, a randomized clinical trial with the aim to evaluate the effects of two water-based aerobic training programs (walking or running in shallow pool) on T2D management will be performed. The sample will be composed by 50 individuals with T2D, of both sexes, aged between 40 and 70 years, who will be randomized into water-based progressive aeroibic training (PAT, n=25) and water-based non-progressive aerobic training (NPAT, n=25). Both trainings will have 12 weeks of duration with 3 weekly sessions (of 50 minutes each). Biochemical, cardiorespiratory fitness, maximum strength, body composition and functional mobility variables, as also quality of life, sleep quality and depressive symptoms will be analyzed before and after the 12 weeks of training.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2
    Keywords
    Exercise, Water-based exercise, Aerobic exercise, Glucose control, Type 2 diabetes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized clinical trial with two interventions in parallel.
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Progressive aerobic training
    Arm Type
    Experimental
    Arm Description
    Water-based aerobic training performed with progression in the training variables. The intervention will be performed during 12 weeks, with 3 weekly sessions (of 50 minutes each), of walking/running in shallow pool.
    Arm Title
    Non-progressive aerobic training
    Arm Type
    Experimental
    Arm Description
    Water-based aerobic training performed without progression in the training variables. The intervention will be performed during 12 weeks, with 3 weekly sessions (of 50 minutes each), of walking/running in shallow pool.
    Intervention Type
    Other
    Intervention Name(s)
    Progressive water-based aerobic training
    Intervention Description
    The intervention will comprise walking/running in shallow pool with progression in the training variables. The training will have 12 weeks of duration with 3 weekly sessions (of 50 minutes each).
    Intervention Type
    Other
    Intervention Name(s)
    Non-progressive aerobic training
    Intervention Description
    The intervention will comprise walking/running in shallow pool without progression in the training variables. The training will have 12 weeks of duration with 3 weekly sessions (of 50 minutes each).
    Primary Outcome Measure Information:
    Title
    Glycated Hemoglobin levels (HbA1c)
    Description
    Blood samples will be used to analyze glycated hemoglobin levels (%)
    Time Frame
    Change from baseline levels of glycated hemoglobin to 12 weeks of intervention.
    Secondary Outcome Measure Information:
    Title
    Fasting plasma glucose
    Description
    in mg/dL
    Time Frame
    At baseline and after a 12-week period
    Title
    Fasting insulin
    Description
    in mg/dL
    Time Frame
    At baseline and after a 12-week period
    Title
    Insulin-resistance index (HOMA-IR)
    Description
    in amount
    Time Frame
    At baseline and after a 12-week period
    Title
    Total cholesterol
    Description
    in mg/dL
    Time Frame
    At baseline and after a 12-week period
    Title
    High density lipoprotein
    Description
    in mg/dL
    Time Frame
    At baseline and after a 12-week period
    Title
    Low density lipoprotein
    Description
    in mg/dL
    Time Frame
    At baseline and after a 12-week period
    Title
    Triglycerides
    Description
    in mg/dL
    Time Frame
    At baseline and after a 12-week period
    Title
    Plasma renin
    Description
    in uIU/mL (microliter)
    Time Frame
    At baseline and after a 12-week period
    Title
    C-reactive protein
    Description
    in mg/L
    Time Frame
    At baseline and after a 12-week period
    Title
    Peak oxygen uptake
    Description
    in ml.kg.min-1
    Time Frame
    At baseline and after a 12-week period
    Title
    Oxygen uptake at the second ventilatory threshold.
    Description
    in ml.kg.min-1
    Time Frame
    At baseline and after a 12-week period
    Title
    Percentage of oxygen consumption in the second ventilatory threshold from the peak oxygen uptake
    Description
    in %
    Time Frame
    At baseline and after a 12-week period
    Title
    Systolic blood pressure.
    Description
    in mmHg
    Time Frame
    At baseline and after a 12-week period
    Title
    Diastolic blood pressure.
    Description
    in mmHg
    Time Frame
    At baseline and after a 12-week period
    Title
    Resting heart rate
    Description
    in beats per minute
    Time Frame
    At baseline and after a 12-week period
    Title
    Maximum dynamic muscle strength (1RM) in the knees extension exercise
    Description
    The test is characterized by greatest load that can be supported in a single execution of knees extension exercise.
    Time Frame
    At baseline and after a 12-week period
    Title
    Muscular resistance (maximal repetitions) in the knees extension exercise.
    Description
    To determine muscular resistance, it will be considered the number of repetitions performed at 60% of 1RM, following a paced pre-established execution. In the post-training evaluation, we will use the load of 60% of 1RM test performed in the pre-training.
    Time Frame
    At baseline and after a 12-week period
    Title
    Timed up-and-go test performed at the usual speed.
    Description
    In seconds
    Time Frame
    At baseline and after a 12-week period
    Title
    Timed up-and-go test performed at the maximal speed.
    Description
    In seconds
    Time Frame
    At baseline and after a 12-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 12-week period
    Title
    Depressive symptoms, evaluated by Depression Inventory Patient Health Questionnaire (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 being the higher score.
    Time Frame
    At baseline and after a 12-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 12-week period
    Title
    Physical activity levels, evaluated by International Physical Activity Questionnaire (IPAQ) - Long Form.
    Description
    The IPAQ asks about three specific types of activity undertaken in the three domains introduced above and sitting time. 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 12-week period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Individuals with type 2 diabetes, of both sexes, aged between 40 and 70 years. Be under medical treatment with oral hypoglycemic agents and / or insulin; Not be 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: Presence of: uncontrolled hypertension; autonomic neuropathy; severe peripheral neuropathy; proliferative diabetic retinopathy; severe non-proliferative diabetic retinopathy; uncompensated heart failure; peripheral amputations; chronic kidney failure; body mass index (BMI)> 45.0 kg/m2; to have some muscle or joint impairment that prevents the performance of physical exercises safely.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Luiz FM Kruel, phd
    Phone
    +555133085820
    Email
    kruel@esef.ufrgs.br
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Luiz FM Kruel, phd
    Organizational Affiliation
    Federal University of Rio Grande do Sul
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Progressive vs. Non-progressive Water-based Aerobic Training on Type 2 Diabetes Control: a Randomized Clinical Trial

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