Diabetes Mellitus, Type 2NCT01956357
Chronic Effects of Two Aerobic-training Models Performed in Water and on Dry Land in Patients With Type 2 Diabetes Mellitus (T2DM).
A study testing Aquatic exercise and Land Exercise in people with Diabetes Mellitus, Type 2, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The aim of this study was to analyse the acute and chronic effects of two aerobic-training models performed in water and on dry land on cardiorespiratory, functional, metabolic, hormonal and quality-of-life parameters in patients with type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Aquatic exercise and Land Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2012to Dec 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The clinical diagnosis of type 2 diabetes mellitus. Not be performing regular and systematic physical exercise for at least three months.
Who cannot join
- Uncontrolled hypertension. Autonomic neuropathy. Severe peripheral neuropathy. Proliferative diabetic retinopathy. Severe nonproliferative diabetic retinopathy. Uncompensated heart failure. Peripheral amputations. Chronic renal failure (GFR by MDRD <30). Muscle or joint injury that prevents physical exercises.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Physical Education School of Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande Do Sil, 90690-200
About this study
The aim of this study was to analyse the acute and chronic effects of two aerobic-training models performed in water and on dry land on cardiorespiratory, functional, metabolic, hormonal and quality-of-life parameters in patients with type 2 diabetes mellitus (T2DM).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Aquatic exercise, Land Exercise
- Keywords
- aquatic exercises;, deep water running;, diabetes;, blood glucose;, inflammation.
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic exerciseOther
Land ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| Aquatic exercise | Experimental | The aquatic aerobic training had a duration of 12 weeks and adopted the interval-training method, with intensities ranging between 85 and 100% of second ventilatory threshold (VT2) and total duration of 45 minute per session.
The sessions consisted of warm up, main part and calm down. The warm-up consisted of a walk in deep water at low intensity for three minutes. The main part was intended to aerobic training in deep water, in which subjects walked and / or ran, depending on your fitness level found in pre-training test. The calm down consisted of walking in deep water at low intensity for two minutes and stretching standardized, emphasizing the muscles worked in the main part of the session, with a total duration of approximately five minutes. Receives: Other: Aquatic exercise |
| Land exercise | Experimental | The land aerobic training had a duration of 12 weeks and adopted the interval-training method, with intensities ranging between 85 and 100% of second ventilatory threshold (VT2) and total duration of 45 minute per session.
The sessions consisted of warm up, main part and calm down. The warm-up consisted of a walk in athletic track at low intensity for three minutes. The main part was intended to aerobic training in athletic track, in which subjects walked and / or ran, depending on your fitness level found in pre-training test. The calm down consisted of walking in athletic track at low intensity for two minutes and stretching standardized, emphasizing the muscles worked in the main part of the session, with a total duration of approximately five minutes. Receives: Other: Land Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin
Measured: Baseline and after 12 weeks of intervention
Secondary outcomes (26)
Fasting plasma glucose.
Measured: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Postprandial glucose
Measured: Baseline and after 12 weeks of intervention.
Fasting insulin.
Measured: Baseline and after 12 weeks of intervention.
Insulin resistance (HOMA-IR).
Measured: Baseline and after 12 weeks of intervention.
Total cholesterol.
Measured: Baseline and after 12 weeks of intervention.
High density lipoprotein.
Measured: Baseline and after 12 weeks of intervention.
Low density lipoprotein.
Measured: Baseline and after 12 weeks of intervention.
Triglycerides.
Measured: Baseline and after 12 weeks of intervention.
Plasma renin activity.
Measured: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Angiotensin II.
Measured: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
C-reactive protein ultrasensitive.
Measured: Baseline and after 12 weeks of intervention.
8-isoprostane
Measured: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Content of reative species (DCF)
Measured: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Water-soluble Fluorescent Substances
Measured: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Oxidation of tyrosine residues
Measured: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Oxidation of tryptophan
Measured: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
superoxide dismutase (SOD)
Measured: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Catalase (CAT)
Measured: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Glutathione peroxidase (GPX)
Measured: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Total radical-trapping antioxidant potential (TRAP)
Measured: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Interleukin 1β
Measured: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Interleukin 10
Measured: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Leukocyte DNA Methylation
Measured: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Purines
Measured: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Interleukin 6
Measured: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Global Histone Deacetylases activity
Measured: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startAug 2012
- Primary completionDec 2012
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.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Sudatti Delevatti, Hospital de Clinicas de Porto Alegre
- Investigators
- Rodrigo S Delevatti, MSc, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956357
- Sponsor's protocol ID
- 54475
- Status last verified
- May 2014
- First submitted
- 27 Sep 2013
- Last updated
- 5 Nov 2014
- Results posted
- No
Publications
S Delevatti R, Schuch FB, Kanitz AC, Alberton CL, Marson EC, Lisboa SC, Pinho CDF, Bregagnol LP, Becker MT, Kruel LFM. Quality of life and sleep quality are similarly improved after aquatic or dry-land aerobic training in patients with type 2 diabetes: A randomized clinical trial. J Sci Med Sport. 2018 May;21(5):483-488. doi: 10.1016/j.jsams.2017.08.024. Epub 2017 Sep 6.
PubMed 28935128Delevatti RS, Pinho CD, Kanitz AC, Alberton CL, Marson EC, Bregagnol LP, Lisboa SC, Schaan BD, Kruel LF. Glycemic reductions following water- and land-based exercise in patients with type 2 diabetes mellitus. Complement Ther Clin Pract. 2016 Aug;24:73-7. doi: 10.1016/j.ctcp.2016.05.008. Epub 2016 May 10.
PubMed 27502804
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Effects of Two Aerobic-training Models Performed in Water and on Dry Land in Patients With Type 2 Diabetes Mellitus (T2DM).
- ClinicalTrials.gov ID
- NCT01956357
- Acronym / sponsor ID
- 54475
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- aquatic exercises;, deep water running;, diabetes;, blood glucose;, inflammation.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (actual)
- First posted
- 8 Oct 2013 (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.
The aim of this study was to analyse the acute and chronic effects of two aerobic-training models performed in water and on dry land on cardiorespiratory, functional, metabolic, hormonal and quality-of-life parameters in patients with type 2 diabetes mellitus (T2DM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aquatic exercise | Experimental | Other: Aquatic exerciseThe aquatic aerobic training had a duration of 12 weeks and adopted the interval-training method, with intensities ranging between 85 and 100% of second ventilatory threshold (VT2) and total duration of 45 minute per session. The sessions consisted of warm up, main part and calm down. The warm-up consisted of a walk in deep water at low intensity for three minutes. The main part was intended to aerobic training in deep water, in which subjects walked and / or ran, depending on your fitness level found in pre-training test. The calm down consisted of walking in deep water at low intensity for two minutes and stretching standardized, emphasizing the muscles worked in the main part of the session, with a total duration of approximately five minutes. |
| Land exercise | Experimental | Other: Land ExerciseThe land aerobic training had a duration of 12 weeks and adopted the interval-training method, with intensities ranging between 85 and 100% of second ventilatory threshold (VT2) and total duration of 45 minute per session. The sessions consisted of warm up, main part and calm down. The warm-up consisted of a walk in athletic track at low intensity for three minutes. The main part was intended to aerobic training in athletic track, in which subjects walked and / or ran, depending on your fitness level found in pre-training test. The calm down consisted of walking in athletic track at low intensity for two minutes and stretching standardized, emphasizing the muscles worked in the main part of the session, with a total duration of approximately five minutes. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The clinical diagnosis of type 2 diabetes mellitus. Not be performing regular and systematic physical exercise for at least three months.
Key exclusion criteria (1 listed)
- Uncontrolled hypertension. Autonomic neuropathy. Severe peripheral neuropathy. Proliferative diabetic retinopathy. Severe nonproliferative diabetic retinopathy. Uncompensated heart failure. Peripheral amputations. Chronic renal failure (GFR by MDRD <30). Muscle or joint injury that prevents physical exercises.
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 |
|---|---|---|
| Aquatic exercise | Other | Aquatic exercise |
| Land Exercise | Other | Land exercise |
Primary outcome
Glycated hemoglobin
Time frame: Baseline and after 12 weeks of intervention
26 secondary outcomes
Fasting plasma glucose.
Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Postprandial glucose
Time frame: Baseline and after 12 weeks of intervention.
Fasting insulin.
Time frame: Baseline and after 12 weeks of intervention.
Insulin resistance (HOMA-IR).
Time frame: Baseline and after 12 weeks of intervention.
Total cholesterol.
Time frame: Baseline and after 12 weeks of intervention.
High density lipoprotein.
Time frame: Baseline and after 12 weeks of intervention.
Low density lipoprotein.
Time frame: Baseline and after 12 weeks of intervention.
Triglycerides.
Time frame: Baseline and after 12 weeks of intervention.
Plasma renin activity.
Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Angiotensin II.
Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
C-reactive protein ultrasensitive.
Time frame: Baseline and after 12 weeks of intervention.
8-isoprostane
Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Content of reative species (DCF)
Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Water-soluble Fluorescent Substances
Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Oxidation of tyrosine residues
Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Oxidation of tryptophan
Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
superoxide dismutase (SOD)
Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Catalase (CAT)
Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Glutathione peroxidase (GPX)
Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Total radical-trapping antioxidant potential (TRAP)
Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Interleukin 1β
Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Interleukin 10
Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Leukocyte DNA Methylation
Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Purines
Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Interleukin 6
Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
Global Histone Deacetylases activity
Time frame: Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.
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 5 Nov 2014.
- Derived from this study: PubMed 28935128S Delevatti R, Schuch FB, Kanitz AC, Alberton CL, Marson EC, Lisboa SC, Pinho CDF, Bregagnol LP, Becker MT, Kruel LFM. Quality of life and sleep quality are similarly improved after aquatic or dry-land aerobic training in patients with type 2 diabetes: A randomized clinical trial. J Sci Med Sport. 2018 May;21(5):483-488. doi: 10.1016/j.jsams.2017.08.024. Epub 2017 Sep 6.
- Derived from this study: PubMed 27502804Delevatti RS, Pinho CD, Kanitz AC, Alberton CL, Marson EC, Bregagnol LP, Lisboa SC, Schaan BD, Kruel LF. Glycemic reductions following water- and land-based exercise in patients with type 2 diabetes mellitus. Complement Ther Clin Pract. 2016 Aug;24:73-7. doi: 10.1016/j.ctcp.2016.05.008. Epub 2016 May 10.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Rodrigo S Delevatti, MSc principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic exercise and Land Exercise in people with Diabetes Mellitus, Type 2, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 1 inclusion and 1 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 5 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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?
Glycated hemoglobin (time frame: Baseline and after 12 weeks of intervention). 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 NCT01956357, 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 5 Nov 2014.