NCT01956357

Brief 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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
Last Updated

November 5, 2014

Status Verified

May 1, 2014

Enrollment Period

4 months

First QC Date

September 27, 2013

Last Update Submit

November 4, 2014

Conditions

Keywords

aquatic exercises;deep water running;diabetes;blood glucose;inflammation.

Outcome Measures

Primary Outcomes (1)

  • Glycated hemoglobin

    Baseline and after 12 weeks of intervention

Secondary Outcomes (26)

  • Fasting plasma glucose.

    Before and after a session of 45 minutes of exercise; baseline and after 12 weeks of intervention.

  • Postprandial glucose

    Baseline and after 12 weeks of intervention.

  • Fasting insulin.

    Baseline and after 12 weeks of intervention.

  • Insulin resistance (HOMA-IR).

    Baseline and after 12 weeks of intervention.

  • Total cholesterol.

    Baseline and after 12 weeks of intervention.

  • +21 more secondary outcomes

Other Outcomes (10)

  • Peak oxygen consumption.

    Baseline and after 12 weeks of intervention.

  • Timed up and go in habitual speed and maximal speed.

    Baseline and after 12 weeks of intervention.

  • Oxygen uptake at ventilatory threshold.

    Baseline and after 12 weeks of intervention.

  • +7 more other outcomes

Study Arms (2)

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.

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.

Other: Land Exercise

Interventions

Aquatic exercise
Land exercise

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The clinical diagnosis of type 2 diabetes mellitus. Not be performing regular and systematic physical exercise for at least three months.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Education School of Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande Do Sil, 90690-200, Brazil

Location

Related Publications (2)

  • 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.

  • Delevatti 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusInflammation

Interventions

Aquatic Therapy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Rodrigo S Delevatti, MSc

    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
PRINCIPAL INVESTIGATOR
PI Title
Effects of two models of aerobic training performed in different environments in patients with type 2 diabetes mellitus

Study Record Dates

First Submitted

September 27, 2013

First Posted

October 8, 2013

Study Start

August 1, 2012

Primary Completion

December 1, 2012

Last Updated

November 5, 2014

Record last verified: 2014-05

Locations