Diabetes Resistance Training Adaptations in Elderly (DRTAE)

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Resistance training; Other: Stretching control

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Hospital de Clinicas de Porto Alegre
    • Porto Alegre, Rio Grande do Sul, Brazil, 90690-000
      • Federal University of Rio Grande do Sul, Physical Education School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resistance training; 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.	Other: Resistance training; 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.
Active Comparator: Stretching control; The control group will perform one stretching session a week.	Other: Stretching control; The stretching session will be composed by stretching and joint mobilization exercises for all body muscles and will happen only one time per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional capacity measure by stair climb test.	Total time, as fast as possible, to climb 10 steps.	12 weeks
Quadriceps muscle strength measured by one repetition maximum (1RM) test.	1RM is a maximum load lifted, reported in kg, during the knee extension.	12 weeks
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.	12 weks
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.	12 weeks
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).	12 weeks
Lipid profile	HDL, LDL, total cholesterol and triglycerides will be measured in a regular laboratorial equipment (COBAS C111)	12 weeks
Glycemic profile	Blood glycated hemoglobin and glucose will be measured in a regular laboratorial equipment (COBAS C111)	12 weeks
Endothelial function measured by ultrasonography	Endothelial function estimated by the response of endothelial cells for hyperemia.	12 weeks
Quadriceps Muscle Quality measure by specific tension	Specific tension is the ratio between muscle strength and muscle mass.	12 weeks
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.	12 weeks
Functional capacity measure by sit-to-stand-up test	The time, as fast as possible, to stand and sit on the chair 10 times.	12 weeks
Quadriceps muscle power capacity measure by rate of torque development.	The rate torque development is a slope of torque/time curve.	12 weeks

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborators: Federal University of Rio Grande do Sul
• Investigators: Study Director: Alexandre S Dias, phd, Hospital de Clinicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: August 25, 2015
• First Submitted That Met QC Criteria: September 10, 2015
• First Posted (Estimate): September 14, 2015

Study Record Updates

• Last Update Posted (Actual): August 3, 2017
• Last Update Submitted That Met QC Criteria: August 2, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 150257

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED