The Diabetes and Aquatic Training Study (DATS)

NCT02612805 | Completed

• 1 other identifier: 15-0380
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Changes in levels of glycated hemoglobin

  Change from Baseline levels of glycated hemoglobin at 15-weeks.

Secondary Outcomes (30)

• Fasting plasma glucose.

  At baseline and after a 15-week period.

• Fasting insulin.

  At baseline and after a 15-week period.

• Insulin-resistance index (HOMA-IR).

  At baseline and after a 15-week period.

• Total cholesterol.

  At baseline and after a 15-week period.

• high density lipoprotein.

  At baseline and after a 15-week period.

Study Arms (3)

Aerobic training group

EXPERIMENTAL

This group perform aerobic hydrogymnastics.

Other: Aerobic training

Combined training group

ACTIVE COMPARATOR

This group perform combined hydrogymnastics.

Other: Combined training

Training placebo

PLACEBO COMPARATOR

This group perform stretching and relaxation in aquatic environment.

Other: Training placebo

Interventions

Aerobic training OTHER

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.

Also known as: Aquatic aerobic training

Aerobic training group

Combined training OTHER

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.

Also known as: Aquatic combined training

Combined training group

Training placebo OTHER

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.

Also known as: Control procedure

Training placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Related Publications (2)

• 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.

  PMID: 35902075 DERIVED

• 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.

  PMID: 32994381 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ricardo Stein, PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2015
• First Posted: November 24, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: May 1, 2016
• Last Updated: August 16, 2016

Record last verified: 2016-08