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

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ClinicalTrials.gov Identifier: NCT04732611
Recruitment Status : Not yet recruiting
First Posted : February 1, 2021
Last Update Posted : February 1, 2021
Sponsor:
Information provided by (Responsible Party):
Jefferson Fagundes Loss, Federal University of Rio Grande do Sul

Study Description
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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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Other: Pilates exercises Other: Walking protocol Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effects of Pilates Exercises Versus Walking on Mechanical and Vascular Variables of Individuals With Type 2 Diabetes Mellitus: Randomized Clinical Trial
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Triceps surae muscle force [ Time Frame: 20 weeks ]
    Triceps surae muscle force assessed by isokinetic dynamometry.

  2. Blood Glycose [ Time Frame: 20 weeks ]
    Blood Glycose assessed by HbA1c


Secondary Outcome Measures :
  1. Triceps surae muscle architecture [ Time Frame: 20 weeks ]
    Triceps surae muscle architecture assessed by ultrasound

  2. Mechanical adaptations of the Achilles tendon [ Time Frame: 20 weeks ]
    Mechanical adaptations of the Achilles tendon assessed by ultrasound

  3. Endothelial function [ Time Frame: 20 weeks ]
    Endothelial function assessed by ultrasound


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04732611


Contacts
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Contact: Edgar Santiago Wagner Neto, Ms +55 51 984419763 edgar.swagner@gmail.com
Contact: Jefferson F Loss, PhD +55 51 33085822 jefferson.loss@ufrgs.br

Sponsors and Collaborators
Federal University of Rio Grande do Sul
Investigators
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Principal Investigator: Jefferson F Loss, PhD Federal University of Rio Grande do Sul
More Information
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Publications:
American College of Sports Medicine. Diretrizes do ACSM para os testes de esforço e sua prescrição. 9 ed. - Rio de Janeiro: Guanabara, 2017
Bland's, M. (2009).
SILVA, N. R.; COSTA, C. E. M. A hiperglicemia e os mecanismos envolvidos nas disfunções vasculares do Diabetes Mellitus. Arq. Ciênc.Saúde Unipar, Umuarama, v. 12, n. 3, p. 265-270, set./dez. 2008
DIABETES CARE. American Diabetes Association. Diagnosis and classification of diabetes mellitus. 2014.
Ferguson B. ACSM's Guidelines for Exercise Testing and Prescription 9th Ed. 2014. J Can Chiropr Assoc. 2014 Sep;58(3):328.
Fowler MJ. Microvascular and macrovascular complications of diabetes. Clin Diabetes. 2008;26(2):77-82
OLIVEIERA, S. G.; ZUGNO, R.; SILVA, P. C. The incidence of type 1 diabetes mellitus in southern Brazil. Revista Saúde e Desenvolvimento, v.13, n.15, 2019.
OLIVEIRA, J. E. P.; VENCIO, S. Diretrizes da Sociedade Brasileira de Diabetes: 2014-2015/ Sociedade Brasileira de Diabetes, São Paulo: AC Farmacêutica, 2015.
SACCO ICN, SARTOR CD, GOMES AA, JOÃO SMA, E CRONFLI R. Avaliação das perdas sensório-motoras do pé e tornozelo decorrentes da neuropatia diabética. Rev. Bras. Fisioter., São Carlos, v. 11, n. 1, p. 27-33, jan./fev. 2007
SENIAM. (2017). Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles. Retrieved from http://www.seniam.org/
SOCIEDADE BRASILEIRA DE DIABETES. Diretrizes Sociedade Brasileira de Diabetes 2017-2018, p.19-26, 2018.

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Responsible Party: Jefferson Fagundes Loss, Professor, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT04732611    
Other Study ID Numbers: 39137
First Posted: February 1, 2021    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jefferson Fagundes Loss, Federal University of Rio Grande do Sul:
Pilates
Walking
Neuromuscular Adaptation
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases