Progressive vs. Non-progressive Water-based Aerobic Training on Type 2 Diabetes Control: a Randomized Clinical Trial

NCT03967561 | Unknown

• 1 other identifier: 2.855.513
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Exercise; Water-based exercise; Aerobic exercise; Glucose control; Type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Glycated Hemoglobin levels (HbA1c)

  Blood samples will be used to analyze glycated hemoglobin levels (%)

  Change from baseline levels of glycated hemoglobin to 12 weeks of intervention.

Secondary Outcomes (23)

• Fasting plasma glucose

  At baseline and after a 12-week period

• Fasting insulin

  At baseline and after a 12-week period

• Insulin-resistance index (HOMA-IR)

  At baseline and after a 12-week period

• Total cholesterol

  At baseline and after a 12-week period

• High density lipoprotein

  At baseline and after a 12-week period

Study Arms (2)

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.

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.

Other: Non-progressive aerobic training

Interventions

Progressive water-based aerobic training OTHER

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).

Progressive aerobic training

Non-progressive aerobic training OTHER

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).

Non-progressive aerobic training

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Luiz FM Kruel, phd

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luiz FM Kruel, phd

CONTACT

+555133085820; kruel@esef.ufrgs.br

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: Associate professor

Model Details: Randomized clinical trial with two interventions in parallel.

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: May 30, 2019
• Study Start: June 10, 2019
• Primary Completion: October 30, 2019
• Study Completion: November 15, 2019
• Last Updated: June 4, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share