Diabetes Resistance Training Adaptations in Elderly
DRTAE
Muscle and Vascular Adaptations Induced by Resistance Training in Elderly Diabetic Type 2
1 other identifier
interventional
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus-type-2
Started Jul 2015
Typical duration for not_applicable diabetes-mellitus-type-2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 25, 2015
CompletedFirst Posted
Study publicly available on registry
September 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedAugust 3, 2017
August 1, 2017
1.4 years
August 25, 2015
August 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (12)
Functional capacity measure by stair climb test.
12 weeks
Quadriceps muscle strength measured by one repetition maximum (1RM) test.
12 weeks
Visceral adipose tissue measured by ultrasonography
12 weks
Muscle thickness measured by ultrasonography
12 weeks
Inflammation status estimated by tumor necrosis factor alpha (TNF-α ) and C reactive protein (CRP)
12 weeks
- +7 more secondary outcomes
Study Arms (2)
Resistance training
EXPERIMENTALResistance 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.
Stretching control
ACTIVE COMPARATORThe control group will perform one stretching session a week.
Interventions
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.
The stretching session will be composed by stretching and joint mobilization exercises for all body muscles and will happen only one time per week.
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- yers and older
- HbA1c \> 6,5%
- BMI from 18,5 kg/m2 - 34,9 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Federal University of Rio Grande do Sul, Physical Education School
Porto Alegre, Rio Grande do Sul, 90690-000, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alexandre S Dias, phd
Hospital de Clinicas de Porto Alegre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2015
First Posted
September 14, 2015
Study Start
July 1, 2015
Primary Completion
December 1, 2016
Study Completion
July 1, 2017
Last Updated
August 3, 2017
Record last verified: 2017-08