Clinical trial NCT04732611: Effects of Pilates Exercises Versus Walking on Mechanical and Vascular Variables of Individuals With Type 2 Diabetes Mellitus
Official title: Effects of Pilates Exercises Versus Walking on Mechanical and Vascular Variables of Individuals With Type 2 Diabetes Mellitus: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Pilates
Walking
Neuromuscular Adaptation
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The Diabetes Mellitus (DM) is a major worldwide public health problem. The hyperglycemia resulting from DM could lead to metabolic adaptations and physiological changes in different body systems. The DM patients are usually sedentary, once the symptoms as the sensory deficits compromise balance and gait. Giving that this sedentary lifestyle needs to be reversed, since physical exercise is well known a fundamental element in the treatment and prevention of the DM.

The major recommendations to this population is the practice of aerobic exercises and the strength training focused on the biggest muscle groups. It is well know that this type of exercise can improve the uptake of intramuscular glucose. In that context the Pilates Method seems as a good option of exercise, once the method works in a global way, working on different muscle groups in the same exercise. Besides that, to the best of our knowledge there aren't enough studies to support the Pilates Method as an alternative type exercise to help in the glycemic control and in the management of this kind of patients. The aim of this study is to evaluate the efficacy and safety of an exercise program using the Pilates Method versus a walking program in neuromuscular, metabolic and vascular variables in type 2 diabetic patients.

60 participants will be recruited by convenience. Individuals will be eligible if \[1\] they had type 2 diabetes mellitus; \[2\] men and women aged 35 to 60 years \[3\] medical approval to practice exercise; \[4\] do not have any bone, joint or muscle disease that make the practice of exercises impossible; \[5\] not being pregnant; \[6\] not being unable to follow the instructions for any reason and \[7\] at least 6 months without exercising. The participants' eligibility will be checked by the researcher. Subsequently, they will be allocated randomly in one of the two groups (Pilates Group or Walking).

Pilates group participants will perform 3 Pilates sessions a week lasting approximately 50 minutes for 20 weeks. Walking group participants will perform 3 walking sessions a week lasting approximately 50 minutes for 20 weeks. All the exercises sessions will be supervised by a professional.

All the participants will be evaluated at the baseline and after 20 weeks of exercises. The main outcome of this study are the Triceps surae muscle force and the blood glycose. The secondary outcomes are Triceps surae muscle architecture, mechanical adaptations of the Achilles tendon and endothelial function.

Our hypothesis is that both groups will be safety and efficiency to improve the Triceps surae muscle force and to decrease blood glycose. Our secondary hypothesis is that the Pilates Group will show better results to both primary outcomes than the walking group.


Eligibility criteria: Criteria:

Inclusion Criteria:

* Men and women between 35 and 65 years old;
* Possess type 2 diabetes mellitus diagnosed;
* Medical approval to practice exercise;
* Do not have any bone, joint or muscle disease that make impossible do the exercises;
* not being pregnant;
* not being unable to follow the instructions for any reason;
* not be exercising for at least 6 months.

Exclusion Criteria:

* Incapacity to follow the instructions for any reason;
* Beginning another treatment for DM2, either physical therapy, exercises or changes of the medical care throughout the study period.
* Having practiced exercises in the last six months;
* Pregnancy;

Primary outcomes:
measure: Triceps surae muscle force
timeFrame: 20 weeks
measure: Blood Glycose
timeFrame: 20 weeks
Secondary outcomes:
measure: Triceps surae muscle architecture
timeFrame: 20 weeks
measure: Mechanical adaptations of the Achilles tendon
timeFrame: 20 weeks
measure: Endothelial function
timeFrame: 20 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Jefferson F Loss, PhD
role: PRINCIPAL_INVESTIGATOR
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