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

Diabetes Mellitus, Type 2 Clinical Trial

— PAT-DM2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03967561
• Other study ID #: 2.855.513
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 10, 2019
• Est. completion date: November 15, 2019

Study information

• Verified date: June 2019
• Source: Federal University of Rio Grande do Sul
• Contact: Luiz FM Kruel, phd
• Phone: +555133085820
• Email: kruel[@]esef.ufrgs.br
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 15, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Progressive water-based aerobic training
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 training
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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fasting plasma glucose	in mg/dL	At baseline and after a 12-week period
Secondary	Fasting insulin	in mg/dL	At baseline and after a 12-week period
Secondary	Insulin-resistance index (HOMA-IR)	in amount	At baseline and after a 12-week period
Secondary	Total cholesterol	in mg/dL	At baseline and after a 12-week period
Secondary	High density lipoprotein	in mg/dL	At baseline and after a 12-week period
Secondary	Low density lipoprotein	in mg/dL	At baseline and after a 12-week period
Secondary	Triglycerides	in mg/dL	At baseline and after a 12-week period
Secondary	Plasma renin	in uIU/mL (microliter)	At baseline and after a 12-week period
Secondary	C-reactive protein	in mg/L	At baseline and after a 12-week period
Secondary	Peak oxygen uptake	in ml.kg.min-1	At baseline and after a 12-week period
Secondary	Oxygen uptake at the second ventilatory threshold.	in ml.kg.min-1	At baseline and after a 12-week period
Secondary	Percentage of oxygen consumption in the second ventilatory threshold from the peak oxygen uptake	in %	At baseline and after a 12-week period
Secondary	Systolic blood pressure.	in mmHg	At baseline and after a 12-week period
Secondary	Diastolic blood pressure.	in mmHg	At baseline and after a 12-week period
Secondary	Resting heart rate	in beats per minute	At baseline and after a 12-week period
Secondary	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.	At baseline and after a 12-week period
Secondary	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.	At baseline and after a 12-week period
Secondary	Timed up-and-go test performed at the usual speed.	In seconds	At baseline and after a 12-week period
Secondary	Timed up-and-go test performed at the maximal speed.	In seconds	At baseline and after a 12-week period
Secondary	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.	At baseline and after a 12-week period
Secondary	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.	At baseline and after a 12-week period
Secondary	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.	At baseline and after a 12-week period
Secondary	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.	At baseline and after a 12-week period