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NCT Number: NCT02548000

Diabetes Resistance Training Adaptations in Elderly

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Rio Grande do Sul, Physical Education School, Porto Alegre, Rio Grande do Sul, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance training

Other

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.

Stretching control

Other

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 outcomes

  1. Quadriceps Muscle Quality measure by echo intensity

    Time frame: 12 weeks

    Echo intensity is a grey scale for analyse the image that ranging from 0 (black) to 255 (white).

Secondary outcomes

  1. Functional capacity measure by stair climb test.

    Time frame: 12 weeks

    Total time, as fast as possible, to climb 10 steps.

  2. Quadriceps muscle strength measured by one repetition maximum (1RM) test.

    Time frame: 12 weeks

    1RM is a maximum load lifted, reported in kg, during the knee extension.

  3. Visceral adipose tissue measured by ultrasonography

    Time frame: 12 weks

    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.

  4. Muscle thickness measured by ultrasonography

    Time frame: 12 weeks

    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.

  5. Inflammation status estimated by tumor necrosis factor alpha (TNF-α ) and C reactive protein (CRP)

    Time frame: 12 weeks

    TNF-α will be evaluated by specific commercial kit and CRP will be measured in a regular laboratorial equipment (COBAS C111).

  6. Lipid profile

    Time frame: 12 weeks

    HDL, LDL, total cholesterol and triglycerides will be measured in a regular laboratorial equipment (COBAS C111)

  7. Glycemic profile

    Time frame: 12 weeks

    Blood glycated hemoglobin and glucose will be measured in a regular laboratorial equipment (COBAS C111)

  8. Endothelial function measured by ultrasonography

    Time frame: 12 weeks

    Endothelial function estimated by the response of endothelial cells for hyperemia.

  9. Quadriceps Muscle Quality measure by specific tension

    Time frame: 12 weeks

    Specific tension is the ratio between muscle strength and muscle mass.

  10. Functional capacity measure by time up and go test

    Time frame: 12 weeks

    Time to get up from the chair walk around the marker (3 m) and return to the sitting position, as fast as possible.

  11. Functional capacity measure by sit-to-stand-up test

    Time frame: 12 weeks

    The time, as fast as possible, to stand and sit on the chair 10 times.

  12. Quadriceps muscle power capacity measure by rate of torque development.

    Time frame: 12 weeks

    The rate torque development is a slope of torque/time curve.

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

  • Federal University of Rio Grande do Sul

Registry information

Official study title

Muscle and Vascular Adaptations Induced by Resistance Training in Elderly Diabetic Type 2

Acronym: DRTAE

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Sep 14, 2015
Registry last updated
Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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