Diabetes Mellitus, Type 2PAT-DM2NCT03967561
Progressive vs. Non-progressive Water-based Aerobic Training on Type 2 Diabetes Control: a Randomized Clinical Trial
A study testing Progressive water-based aerobic training and Non-progressive aerobic training in people with Diabetes Mellitus, Type 2, run by Federal University of Rio Grande do Sul.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Progressive water-based aerobic training and Non-progressive aerobic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2019to 15 Nov 2019
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Presence of:
- uncontrolled hypertension;
- autonomic neuropathy;
- severe peripheral neuropathy;
- proliferative diabetic retinopathy;
- severe non-proliferative diabetic retinopathy;
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Progressive vs. Non-progressive Water-based Aerobic Training on Type 2 Diabetes Control: a Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Progressive water-based aerobic training, Non-progressive aerobic training
- Keywords
- Exercise, Water-based exercise, Aerobic exercise, Glucose control, Type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive water-based aerobic trainingOther
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).
Non-progressive aerobic trainingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Progressive aerobic training | Experimental | 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. Receives: Other: Progressive water-based aerobic training |
| Non-progressive aerobic training | Experimental | 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. Receives: Other: Non-progressive aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated Hemoglobin levels (HbA1c)
Blood samples will be used to analyze glycated hemoglobin levels (%)
Measured: Change from baseline levels of glycated hemoglobin to 12 weeks of intervention.
Secondary outcomes (23)
Fasting plasma glucose
in mg/dL
Measured: At baseline and after a 12-week period
Fasting insulin
in mg/dL
Measured: At baseline and after a 12-week period
Insulin-resistance index (HOMA-IR)
in amount
Measured: At baseline and after a 12-week period
Total cholesterol
in mg/dL
Measured: At baseline and after a 12-week period
High density lipoprotein
in mg/dL
Measured: At baseline and after a 12-week period
Low density lipoprotein
in mg/dL
Measured: At baseline and after a 12-week period
Triglycerides
in mg/dL
Measured: At baseline and after a 12-week period
Plasma renin
in uIU/mL (microliter)
Measured: At baseline and after a 12-week period
C-reactive protein
in mg/L
Measured: At baseline and after a 12-week period
Peak oxygen uptake
in ml.kg.min-1
Measured: At baseline and after a 12-week period
Oxygen uptake at the second ventilatory threshold.
in ml.kg.min-1
Measured: At baseline and after a 12-week period
Percentage of oxygen consumption in the second ventilatory threshold from the peak oxygen uptake
in %
Measured: At baseline and after a 12-week period
Systolic blood pressure.
in mmHg
Measured: At baseline and after a 12-week period
Diastolic blood pressure.
in mmHg
Measured: At baseline and after a 12-week period
Resting heart rate
in beats per minute
Measured: At baseline and after a 12-week period
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.
Measured: At baseline and after a 12-week period
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.
Measured: At baseline and after a 12-week period
Timed up-and-go test performed at the usual speed.
In seconds
Measured: At baseline and after a 12-week period
Timed up-and-go test performed at the maximal speed.
In seconds
Measured: At baseline and after a 12-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 12-week period
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.
Measured: At baseline and after a 12-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 12-week period
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.
Measured: At baseline and after a 12-week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start10 Jun 2019 (estimated)
- Primary completion30 Oct 2019 (estimated)
- Study completion15 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Randomized clinical trial with two interventions in parallel.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Luiz Fernando Martins Kruel, Federal University of Rio Grande do Sul
- Investigators
- Luiz FM Kruel, phd, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967561
- Sponsor's protocol ID
- 2.855.513
- Acronym
- PAT-DM2
- Status last verified
- Jun 2019
- First submitted
- 27 May 2019
- Last updated
- 4 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Progressive vs. Non-progressive Water-based Aerobic Training on Type 2 Diabetes Control: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03967561
- Acronym / sponsor ID
- PAT-DM2 / 2.855.513
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Exercise, Water-based exercise, Aerobic exercise, Glucose control, Type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 10 Jun 2019 (estimated)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 15 Nov 2019 (estimated)
- First posted
- 30 May 2019 (actual)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial with two interventions in parallel.
| Arm | Type | Receives |
|---|---|---|
| Progressive aerobic training | Experimental | Other: Progressive water-based aerobic trainingWater-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. |
| Non-progressive aerobic training | Experimental | Other: Non-progressive aerobic trainingWater-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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (11 listed)
- Presence of:
- uncontrolled hypertension;
- autonomic neuropathy;
- severe peripheral neuropathy;
- proliferative diabetic retinopathy;
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 |
|---|---|---|
| Progressive water-based aerobic trainingThe 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). | Other | Progressive aerobic training |
| Non-progressive aerobic trainingThe 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). | Other | Non-progressive aerobic training |
Primary outcome
Glycated Hemoglobin levels (HbA1c)
Time frame: Change from baseline levels of glycated hemoglobin to 12 weeks of intervention.
Blood samples will be used to analyze glycated hemoglobin levels (%)
23 secondary outcomes
Fasting plasma glucose
Time frame: At baseline and after a 12-week period
Fasting insulin
Time frame: At baseline and after a 12-week period
Insulin-resistance index (HOMA-IR)
Time frame: At baseline and after a 12-week period
Total cholesterol
Time frame: At baseline and after a 12-week period
High density lipoprotein
Time frame: At baseline and after a 12-week period
Low density lipoprotein
Time frame: At baseline and after a 12-week period
Triglycerides
Time frame: At baseline and after a 12-week period
Plasma renin
Time frame: At baseline and after a 12-week period
C-reactive protein
Time frame: At baseline and after a 12-week period
Peak oxygen uptake
Time frame: At baseline and after a 12-week period
Oxygen uptake at the second ventilatory threshold.
Time frame: At baseline and after a 12-week period
Percentage of oxygen consumption in the second ventilatory threshold from the peak oxygen uptake
Time frame: At baseline and after a 12-week period
Systolic blood pressure.
Time frame: At baseline and after a 12-week period
Diastolic blood pressure.
Time frame: At baseline and after a 12-week period
Resting heart rate
Time frame: At baseline and after a 12-week period
Maximum dynamic muscle strength (1RM) in the knees extension exercise
Time frame: At baseline and after a 12-week period
Muscular resistance (maximal repetitions) in the knees extension exercise.
Time frame: At baseline and after a 12-week period
Timed up-and-go test performed at the usual speed.
Time frame: At baseline and after a 12-week period
Timed up-and-go test performed at the maximal speed.
Time frame: At baseline and after a 12-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 12-week period
Depressive symptoms, evaluated by Depression Inventory Patient Health Questionnaire (PHQ-9)
Time frame: At baseline and after a 12-week period
Sleep quality, evaluated by Pittsburgh Sleep Scale
Time frame: At baseline and after a 12-week period
Physical activity levels, evaluated by International Physical Activity Questionnaire (IPAQ) - Long Form.
Time frame: At baseline and after a 12-week period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Luiz FM Kruel, phd principal investigator
Federal University of Rio Grande do Sul
Questions about this trial
What is this clinical trial studying?
A study testing Progressive water-based aerobic training and Non-progressive aerobic training in people with Diabetes Mellitus, Type 2, run by Federal University of Rio Grande do Sul.
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 11 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: status not confirmed, as of the sponsor's last update on 4 Jun 2019. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luiz FM Kruel, phd (+555133085820, kruel@esef.ufrgs.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated Hemoglobin levels (HbA1c) (time frame: Change from baseline levels of glycated hemoglobin to 12 weeks of intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2019.