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

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
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
NCT ID
NCT03967561
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.
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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