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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pilates exercises
Walking protocol
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 2 focused on measuring Pilates, Walking, Neuromuscular Adaptation

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Pilates

    Walking

    Arm Description

    Pilates group participants will perform 3 weekly Pilates sessions lasting approximately 50 minutes for 20 weeks.

    Walking group participants will perform 3 weekly walking sessions lasting approximately 50 minutes for 20 weeks

    Outcomes

    Primary Outcome Measures

    Triceps surae muscle force
    Triceps surae muscle force assessed by isokinetic dynamometry.
    Blood Glycose
    Blood Glycose assessed by HbA1c

    Secondary Outcome Measures

    Triceps surae muscle architecture
    Triceps surae muscle architecture assessed by ultrasound
    Mechanical adaptations of the Achilles tendon
    Mechanical adaptations of the Achilles tendon assessed by ultrasound
    Endothelial function
    Endothelial function assessed by ultrasound

    Full Information

    First Posted
    January 17, 2021
    Last Updated
    January 26, 2021
    Sponsor
    Federal University of Rio Grande do Sul
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04732611
    Brief Title
    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

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2021 (Anticipated)
    Primary Completion Date
    April 2021 (Anticipated)
    Study Completion Date
    August 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Rio Grande do Sul

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2
    Keywords
    Pilates, Walking, Neuromuscular Adaptation

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pilates
    Arm Type
    Experimental
    Arm Description
    Pilates group participants will perform 3 weekly Pilates sessions lasting approximately 50 minutes for 20 weeks.
    Arm Title
    Walking
    Arm Type
    Active Comparator
    Arm Description
    Walking group participants will perform 3 weekly walking sessions lasting approximately 50 minutes for 20 weeks
    Intervention Type
    Other
    Intervention Name(s)
    Pilates exercises
    Intervention Description
    Pilates group participants will perform 3 weekly Pilates sessions lasting approximately 50 minutes for 20 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Walking protocol
    Intervention Description
    Walking group participants will perform 3 weekly walking sessions lasting approximately 50 minutes for 20 weeks.
    Primary Outcome Measure Information:
    Title
    Triceps surae muscle force
    Description
    Triceps surae muscle force assessed by isokinetic dynamometry.
    Time Frame
    20 weeks
    Title
    Blood Glycose
    Description
    Blood Glycose assessed by HbA1c
    Time Frame
    20 weeks
    Secondary Outcome Measure Information:
    Title
    Triceps surae muscle architecture
    Description
    Triceps surae muscle architecture assessed by ultrasound
    Time Frame
    20 weeks
    Title
    Mechanical adaptations of the Achilles tendon
    Description
    Mechanical adaptations of the Achilles tendon assessed by ultrasound
    Time Frame
    20 weeks
    Title
    Endothelial function
    Description
    Endothelial function assessed by ultrasound
    Time Frame
    20 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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;
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Edgar Santiago Wagner Neto, Ms
    Phone
    +55 51 984419763
    Email
    edgar.swagner@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jefferson F Loss, PhD
    Phone
    +55 51 33085822
    Email
    jefferson.loss@ufrgs.br
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jefferson F Loss, PhD
    Organizational Affiliation
    Federal University of Rio Grande do Sul
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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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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