Diabetes Resistance Training Adaptations in Elderly

Diabetes Mellitus, Type 2 Clinical Trial

— DRTAE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02548000
• Other study ID #: 150257
• Status: Completed
• Phase: N/A
• First received: August 25, 2015
• Last updated: August 2, 2017
• Start date: July 2015
• Est. completion date: July 2017

Study information

• Verified date: August 2017
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Federal University of Rio Grande do Sul, Physical Education School	Porto Alegre	Rio Grande do Sul
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Functional capacity measure by stair climb test.	Total time, as fast as possible, to climb 10 steps.	12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Inflammation status estimated by tumor necrosis factor alpha (TNF-a ) and C reactive protein (CRP)	TNF-a will be evaluated by specific commercial kit and CRP will be measured in a regular laboratorial equipment (COBAS C111).	12 weeks
Secondary	Lipid profile	HDL, LDL, total cholesterol and triglycerides will be measured in a regular laboratorial equipment (COBAS C111)	12 weeks
Secondary	Glycemic profile	Blood glycated hemoglobin and glucose will be measured in a regular laboratorial equipment (COBAS C111)	12 weeks
Secondary	Endothelial function measured by ultrasonography	Endothelial function estimated by the response of endothelial cells for hyperemia.	12 weeks
Secondary	Quadriceps Muscle Quality measure by specific tension	Specific tension is the ratio between muscle strength and muscle mass.	12 weeks
Secondary	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
Secondary	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
Secondary	Quadriceps muscle power capacity measure by rate of torque development.	The rate torque development is a slope of torque/time curve.	12 weeks