Effects of Pilates Exercises Versus Walking on Mechanical and Vascular Variables of Individuals With Type 2 Diabetes Mellitus

January 26, 2021 updated by: Jefferson Fagundes Loss, Federal University of Rio Grande do Sul

Effects of Pilates Exercises Versus Walking on Mechanical and Vascular Variables of Individuals With Type 2 Diabetes Mellitus: Randomized Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pilates
Pilates group participants will perform 3 weekly Pilates sessions lasting approximately 50 minutes for 20 weeks.
Other: Pilates exercises
Pilates group participants will perform 3 weekly Pilates sessions lasting approximately 50 minutes for 20 weeks.
Active Comparator: Walking
Walking group participants will perform 3 weekly walking sessions lasting approximately 50 minutes for 20 weeks
Other: Walking protocol
Walking group participants will perform 3 weekly walking sessions lasting approximately 50 minutes for 20 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Triceps surae muscle force
Time Frame: 20 weeks
Triceps surae muscle force assessed by isokinetic dynamometry.
20 weeks
Blood Glycose
Time Frame: 20 weeks
Blood Glycose assessed by HbA1c
20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Triceps surae muscle architecture
Time Frame: 20 weeks
Triceps surae muscle architecture assessed by ultrasound
20 weeks
Mechanical adaptations of the Achilles tendon
Time Frame: 20 weeks
Mechanical adaptations of the Achilles tendon assessed by ultrasound
20 weeks
Endothelial function
Time Frame: 20 weeks
Endothelial function assessed by ultrasound
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Rio Grande do Sul

Investigators

  • Principal Investigator: Jefferson F Loss, PhD, Federal University of Rio Grande do Sul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

January 17, 2021

First Submitted That Met QC Criteria

January 26, 2021

First Posted (Actual)

February 1, 2021

Study Record Updates

Last Update Posted (Actual)

February 1, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 39137 (Other Identifier: DAIDS-ES ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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