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Diabetes Resistance Training Adaptations in Elderly (DRTAE)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Resistance training
Stretching control
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 2

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 2 diabetes
  • 60 yers and older
  • HbA1c > 6,5%
  • BMI from 18,5 kg/m2 - 34,9 kg/m2

Exclusion Criteria:

  • Current smoking
  • Insulin users
  • Hypertension uncontrolled
  • Diabetic neuropathy
  • Diabetic retinopathy
  • Diabetic nephropathy
  • Peripheral amputations
  • Clinical depression
  • Myocardial infarction (within past 6 months)
  • Any unstable chronic condition
  • Muscle-skeletal complications that limit the practice of the exercises

Sites / Locations

  • Hospital de Clinicas de Porto Alegre
  • Federal University of Rio Grande do Sul, Physical Education School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Resistance training

Stretching control

Arm Description

Resistance training will be performed three times a week, for 12 weeks, composed by 12 resistance exercises for all body muscles with 2-3 series and 12-8 repetitions in each exercise.

The control group will perform one stretching session a week.

Outcomes

Primary Outcome Measures

Quadriceps Muscle Quality measure by echo intensity
Echo intensity is a grey scale for analyse the image that ranging from 0 (black) to 255 (white).

Secondary Outcome Measures

Functional capacity measure by stair climb test.
Total time, as fast as possible, to climb 10 steps.
Quadriceps muscle strength measured by one repetition maximum (1RM) test.
1RM is a maximum load lifted, reported in kg, during the knee extension.
Visceral adipose tissue measured by ultrasonography
Visceral adipose tissue (VAT) thickness measured by ultrasonography. The VAT thickness is considered from the back of the subcutaneous tissue until the anterior part of the aorta. It is reported in mm.
Muscle thickness measured by ultrasonography
Muscle thickness measured by ultrasonography takes into account the superior fascia of the muscle and the distance until the inferior fascia. It is reported in mm.
Inflammation status estimated by tumor necrosis factor alpha (TNF-α ) and C reactive protein (CRP)
TNF-α will be evaluated by specific commercial kit and CRP will be measured in a regular laboratorial equipment (COBAS C111).
Lipid profile
HDL, LDL, total cholesterol and triglycerides will be measured in a regular laboratorial equipment (COBAS C111)
Glycemic profile
Blood glycated hemoglobin and glucose will be measured in a regular laboratorial equipment (COBAS C111)
Endothelial function measured by ultrasonography
Endothelial function estimated by the response of endothelial cells for hyperemia.
Quadriceps Muscle Quality measure by specific tension
Specific tension is the ratio between muscle strength and muscle mass.
Functional capacity measure by time up and go test
Time to get up from the chair walk around the marker (3 m) and return to the sitting position, as fast as possible.
Functional capacity measure by sit-to-stand-up test
The time, as fast as possible, to stand and sit on the chair 10 times.
Quadriceps muscle power capacity measure by rate of torque development.
The rate torque development is a slope of torque/time curve.

Full Information

First Posted
August 25, 2015
Last Updated
August 2, 2017
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT02548000
Brief Title
Diabetes Resistance Training Adaptations in Elderly
Acronym
DRTAE
Official Title
Muscle and Vascular Adaptations Induced by Resistance Training in Elderly Diabetic Type 2
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to verify the effects of resistance training on neuromuscular, vascular and functional adaptations of elderly diabetics type 2. Half of participants will be the intervention group that will perform resistance training, while the other half will be the control group that will perform stretching sessions.
Detailed Description
Resistance training may be an interesting strategy to fight diabetes deleterious conditions, as it is known to increase muscle mass and quality, strength, functional capacity, vascular health, and decrease inflammation status and blood lipids, besides leading to improves in glycemic control. To test this hypothesis, 42 diabetic patients will be recruited and randomized to two groups that will be evaluated before and after 12 weeks of both intervention or control period. The resistance training group will perform all body resistance exercises three times per week, while the control group will perform a stretching session one time per week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resistance training
Arm Type
Experimental
Arm Description
Resistance training will be performed three times a week, for 12 weeks, composed by 12 resistance exercises for all body muscles with 2-3 series and 12-8 repetitions in each exercise.
Arm Title
Stretching control
Arm Type
Active Comparator
Arm Description
The control group will perform one stretching session a week.
Intervention Type
Other
Intervention Name(s)
Resistance training
Intervention Description
The resistance training will be compound by 12 exercises for all body muscles, performed three times per week. The intensity of training will be measure by maximum repetitions from 12 until 8 repetitions with 2-3 series. The loads will increase for keep the maximum strength as the capacity of patients. The blood pressure and the casual glycemic will be measure before and after the training in each session. Before to start the exercises, patients will perform a warming on treadmill for 10 minutes and after the training will perform some stretching exercises for muscles groups trained.
Intervention Type
Other
Intervention Name(s)
Stretching control
Intervention Description
The stretching session will be composed by stretching and joint mobilization exercises for all body muscles and will happen only one time per week.
Primary Outcome Measure Information:
Title
Quadriceps Muscle Quality measure by echo intensity
Description
Echo intensity is a grey scale for analyse the image that ranging from 0 (black) to 255 (white).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Functional capacity measure by stair climb test.
Description
Total time, as fast as possible, to climb 10 steps.
Time Frame
12 weeks
Title
Quadriceps muscle strength measured by one repetition maximum (1RM) test.
Description
1RM is a maximum load lifted, reported in kg, during the knee extension.
Time Frame
12 weeks
Title
Visceral adipose tissue measured by ultrasonography
Description
Visceral adipose tissue (VAT) thickness measured by ultrasonography. The VAT thickness is considered from the back of the subcutaneous tissue until the anterior part of the aorta. It is reported in mm.
Time Frame
12 weks
Title
Muscle thickness measured by ultrasonography
Description
Muscle thickness measured by ultrasonography takes into account the superior fascia of the muscle and the distance until the inferior fascia. It is reported in mm.
Time Frame
12 weeks
Title
Inflammation status estimated by tumor necrosis factor alpha (TNF-α ) and C reactive protein (CRP)
Description
TNF-α will be evaluated by specific commercial kit and CRP will be measured in a regular laboratorial equipment (COBAS C111).
Time Frame
12 weeks
Title
Lipid profile
Description
HDL, LDL, total cholesterol and triglycerides will be measured in a regular laboratorial equipment (COBAS C111)
Time Frame
12 weeks
Title
Glycemic profile
Description
Blood glycated hemoglobin and glucose will be measured in a regular laboratorial equipment (COBAS C111)
Time Frame
12 weeks
Title
Endothelial function measured by ultrasonography
Description
Endothelial function estimated by the response of endothelial cells for hyperemia.
Time Frame
12 weeks
Title
Quadriceps Muscle Quality measure by specific tension
Description
Specific tension is the ratio between muscle strength and muscle mass.
Time Frame
12 weeks
Title
Functional capacity measure by time up and go test
Description
Time to get up from the chair walk around the marker (3 m) and return to the sitting position, as fast as possible.
Time Frame
12 weeks
Title
Functional capacity measure by sit-to-stand-up test
Description
The time, as fast as possible, to stand and sit on the chair 10 times.
Time Frame
12 weeks
Title
Quadriceps muscle power capacity measure by rate of torque development.
Description
The rate torque development is a slope of torque/time curve.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes 60 yers and older HbA1c > 6,5% BMI from 18,5 kg/m2 - 34,9 kg/m2 Exclusion Criteria: Current smoking Insulin users Hypertension uncontrolled Diabetic neuropathy Diabetic retinopathy Diabetic nephropathy Peripheral amputations Clinical depression Myocardial infarction (within past 6 months) Any unstable chronic condition Muscle-skeletal complications that limit the practice of the exercises
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre S Dias, phd
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Federal University of Rio Grande do Sul, Physical Education School
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90690-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Diabetes Resistance Training Adaptations in Elderly

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