NCT02548000

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

2 active sites

Status
completed

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

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 14, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

1.4 years

First QC Date

August 25, 2015

Last Update Submit

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

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.

Other: Resistance training

Stretching control

ACTIVE COMPARATOR

The control group will perform one stretching session a week.

Other: Stretching control

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.

Resistance training

The stretching session will be composed by stretching and joint mobilization exercises for all body muscles and will happen only one time per week.

Stretching control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Federal University of Rio Grande do Sul, Physical Education School

Porto Alegre, Rio Grande do Sul, 90690-000, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Alexandre S Dias, phd

    Hospital de Clinicas de Porto Alegre

    STUDY DIRECTOR

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

Locations