Clinical trial NCT02548000: Diabetes Resistance Training Adaptations in Elderly
Official title: Muscle and Vascular Adaptations Induced by Resistance Training in Elderly Diabetic Type 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
First posted: 2015-09-14
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Quadriceps Muscle Quality measure by echo intensity
timeFrame: 12 weeks
Secondary outcomes:
measure: Functional capacity measure by stair climb test.
timeFrame: 12 weeks
measure: Quadriceps muscle strength measured by one repetition maximum (1RM) test.
timeFrame: 12 weeks
measure: Visceral adipose tissue measured by ultrasonography
timeFrame: 12 weks
measure: Muscle thickness measured by ultrasonography
timeFrame: 12 weeks
measure: Inflammation status estimated by tumor necrosis factor alpha (TNF-α ) and C reactive protein (CRP)
timeFrame: 12 weeks
measure: Lipid profile
timeFrame: 12 weeks
measure: Glycemic profile
timeFrame: 12 weeks
measure: Endothelial function measured by ultrasonography
timeFrame: 12 weeks
measure: Quadriceps Muscle Quality measure by specific tension
timeFrame: 12 weeks
measure: Functional capacity measure by time up and go test
timeFrame: 12 weeks
measure: Functional capacity measure by sit-to-stand-up test
timeFrame: 12 weeks
measure: Quadriceps muscle power capacity measure by rate of torque development.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Federal University of Rio Grande do Sul, Physical Education School
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Alexandre S Dias, phd
role: STUDY_DIRECTOR
References: