Diabetes Mellitus, Type 2DRTAENCT02548000
Diabetes Resistance Training Adaptations in Elderly
A study testing Resistance training in people with Diabetes Mellitus, Type 2, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesBrazil
- Study dates
- Jul 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- 60 yers and older
- HbA1c > 6,5%
- BMI from 18,5 kg/m2 - 34,9 kg/m2
Who cannot join
- Current smoking
- Insulin users
- Hypertension uncontrolled
- Diabetic neuropathy
- Diabetic retinopathy
- Diabetic nephropathy
Show all 11Show fewer
- Peripheral amputations
- Clinical depression
- Myocardial infarction (within past 6 months)
- Any unstable chronic condition
- Muscle-skeletal complications that limit the practice of the exercises
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Federal University of Rio Grande do Sul, Physical Education School
Porto Alegre, Rio Grande do Sul, 90690-000
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Resistance training, Stretching control
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingOther
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 controlOther
The stretching session will be composed by stretching and joint mobilization exercises for all body muscles and will happen only one time per week.
| Study group | Role | What they receive |
|---|---|---|
| Resistance training | Experimental | 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. Receives: Other: Resistance training |
| Stretching control | Active comparator | The control group will perform one stretching session a week. Receives: Other: Stretching control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Secondary outcomes (12)
Functional capacity measure by stair climb test.
Total time, as fast as possible, to climb 10 steps.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 12 weeks
Lipid profile
HDL, LDL, total cholesterol and triglycerides will be measured in a regular laboratorial equipment (COBAS C111)
Measured: 12 weeks
Glycemic profile
Blood glycated hemoglobin and glucose will be measured in a regular laboratorial equipment (COBAS C111)
Measured: 12 weeks
Endothelial function measured by ultrasonography
Endothelial function estimated by the response of endothelial cells for hyperemia.
Measured: 12 weeks
Quadriceps Muscle Quality measure by specific tension
Specific tension is the ratio between muscle strength and muscle mass.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Quadriceps muscle power capacity measure by rate of torque development.
The rate torque development is a slope of torque/time curve.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Sponsor
- Investigators
- Alexandre S Dias, phd, Study director, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548000
- Sponsor's protocol ID
- 150257
- Acronym
- DRTAE
- Status last verified
- Aug 2017
- First submitted
- 25 Aug 2015
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle and Vascular Adaptations Induced by Resistance Training in Elderly Diabetic Type 2
- ClinicalTrials.gov ID
- NCT02548000
- Acronym / sponsor ID
- DRTAE / 150257
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- Jul 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 14 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance training | Experimental | Other: Resistance trainingResistance 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 comparator | Other: Stretching controlThe control group will perform one stretching session a week. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes
- 60 yers and older
- HbA1c > 6,5%
- BMI from 18,5 kg/m2 - 34,9 kg/m2
Key exclusion criteria (11 listed)
- Current smoking
- Insulin users
- Hypertension uncontrolled
- Diabetic neuropathy
- Diabetic retinopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance trainingThe 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. | Other | Resistance training |
| Stretching controlThe stretching session will be composed by stretching and joint mobilization exercises for all body muscles and will happen only one time per week. | Other | Stretching control |
Primary outcome
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).
12 secondary outcomes
Functional capacity measure by stair climb test.
Time frame: 12 weeks
Quadriceps muscle strength measured by one repetition maximum (1RM) test.
Time frame: 12 weeks
Visceral adipose tissue measured by ultrasonography
Time frame: 12 weks
Muscle thickness measured by ultrasonography
Time frame: 12 weeks
Inflammation status estimated by tumor necrosis factor alpha (TNF-α ) and C reactive protein (CRP)
Time frame: 12 weeks
Lipid profile
Time frame: 12 weeks
Glycemic profile
Time frame: 12 weeks
Endothelial function measured by ultrasonography
Time frame: 12 weeks
Quadriceps Muscle Quality measure by specific tension
Time frame: 12 weeks
Functional capacity measure by time up and go test
Time frame: 12 weeks
Functional capacity measure by sit-to-stand-up test
Time frame: 12 weeks
Quadriceps muscle power capacity measure by rate of torque development.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre S Dias, phd study director
Hospital de Clinicas de Porto Alegre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training in people with Diabetes Mellitus, Type 2, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps Muscle Quality measure by echo intensity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017.