<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02253615</url>
  </required_header>
  <id_info>
    <org_study_id>ERT-2014</org_study_id>
    <nct_id>NCT02253615</nct_id>
  </id_info>
  <brief_title>Effects of Resistance Training in Untrained Older Adults</brief_title>
  <official_title>Effects of 16 Weeks of Resistance Training Using Elastic Resistance or Machines on Muscle Mass, Strength and Postural Control in Untrained Older Adults.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Brasilia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Brasilia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The latest randomized controlled trials and systematic reviews of resistance training&#xD;
      performed by older adults reported that the systematic use of exercise in machines improves&#xD;
      muscle strength and power, functional abilities, body mass and body balance. However, the&#xD;
      effect of resistance training with elastic tubes exercises have not been studied in all the&#xD;
      variables described above. The objective of this study is to analyze the effects of elastic&#xD;
      tubes exercises on muscle mass, muscle strength, functional performance and postural control&#xD;
      in elderly untrained.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized clinical trial study (RCT) with 2 parallel arms. The subjects will be&#xD;
      divided in 2 groups with a randomized block technique: Elastic Training Group (ETG) and&#xD;
      Machine Training Group (MTG). The subjects will be submitted to a two-week familiarization&#xD;
      period and then a sixteen-week of strength training program will be performed twice a week.&#xD;
&#xD;
      This regimen of resistance training in both groups will consist of four exercises for lower&#xD;
      limbs and four exercises for upper limbs which will be alternately performed with a&#xD;
      one-minute interval between them during familiarization and training periods. Lower limb&#xD;
      exercises will consist of: hip extension and abduction, and knee flexion and extension. Upper&#xD;
      limb exercises will consist of: bench press, rowing, triceps and high pulley exercise.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Body Mass</measure>
    <time_frame>Change from baseline in body mass at 16 weeks.</time_frame>
    <description>To assess muscle mass, a Dual-energy X-ray Absortiometry (DXA) (GE Electric Company®, Lunar Prodigy) will be used.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Muscle Strength</measure>
    <time_frame>Change from baseline in muscle strength at 16 weeks.</time_frame>
    <description>Lower limb muscle strength will be assessed with an isokinetic dynamometer (Biodex System®, model III) and upper limb muscle strength with an isometric dynamometer (Jamar®, Hand Dynamometer).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Postural Balance</measure>
    <time_frame>Change from baseline in postural balance at 16 weeks.</time_frame>
    <description>The postural balance will be assessed with a three-dimensional (3D) motion analysis system and force plates.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Functional performance</measure>
    <time_frame>Before and after 16 weeks of resistance training</time_frame>
    <description>The functional performance will be assessed with Ten Meters Walk Test (TMW), Timed Up&amp;Go Test (TUG) and 30 Second Chair Stand Test (T30).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Aging</condition>
  <condition>Older Adults</condition>
  <arm_group>
    <arm_group_label>Machine resistance training (MRT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The machine resistance training will consist of four exercises for lower limbs and four exercises for upper limbs which will be alternately performed with a one-minute interval between them during familiarization and training periods. Lower limb exercises will consist of: hip extension and abduction, and knee flexion and extension. Upper limb exercises will consist of: bench press, rowing, triceps and high pulley exercise.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Elastic resistance training (ERT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The elastic resistance training will consist of four exercises for lower limbs and four exercises for upper limbs which will be alternately performed with a one-minute interval between them during familiarization and training periods. Lower limb exercises will consist of: hip extension and abduction, and knee flexion and extension. Upper limb exercises will consist of: bench press, rowing, triceps and high pulley exercise.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Machines exercises</intervention_name>
    <description>Resistance training in pneumatic machines.</description>
    <arm_group_label>Machine resistance training (MRT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Elastic exercises</intervention_name>
    <description>Resistance training with elastic tubes.</description>
    <arm_group_label>Elastic resistance training (ERT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Convenience sample of forty healthy older adults with a minimum of 55 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subjects suffering from orthopedic, neurologic, rheumatologic, metabolic or heart&#xD;
             conditions, and uncontrolled arterial hypertension. Additional exclusion criteria&#xD;
             included undergoing estrogen therapy, use of cardiac pacemaker, knee or hip&#xD;
             arthroplasty, the presence of fragments from previous osteosynthesis; orthopedic&#xD;
             surgery, fractures, muscle injury or the practice of resistance training within the&#xD;
             last 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Brasilia</name>
      <address>
        <city>Brasilia</city>
        <state>Distrito Federal</state>
        <zip>72220-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Brasilia</name>
      <address>
        <city>Brasília</city>
        <state>Distrito Federal</state>
        <zip>72220-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Lorenz DS. Variable resistance training using elastic bands to enhance lower extremity strengthening. Int J Sports Phys Ther. 2014 May;9(3):410-4.</citation>
    <PMID>24944861</PMID>
  </reference>
  <reference>
    <citation>Joy JM, Lowery RP, Oliveira de Souza E, Wilson JM. Elastic Bands as a Component of Periodized Resistance Training. J Strength Cond Res. 2016 Aug;30(8):2100-6. doi: 10.1519/JSC.0b013e3182986bef.</citation>
    <PMID>23669815</PMID>
  </reference>
  <reference>
    <citation>Martins WR, de Oliveira RJ, Carvalho RS, de Oliveira Damasceno V, da Silva VZ, Silva MS. Elastic resistance training to increase muscle strength in elderly: a systematic review with meta-analysis. Arch Gerontol Geriatr. 2013 Jul-Aug;57(1):8-15. doi: 10.1016/j.archger.2013.03.002. Epub 2013 Apr 4.</citation>
    <PMID>23562413</PMID>
  </reference>
  <results_reference>
    <citation>American College of Sports Medicine; Chodzko-Zajko WJ, Proctor DN, Fiatarone Singh MA, Minson CT, Nigg CR, Salem GJ, Skinner JS. American College of Sports Medicine position stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 2009 Jul;41(7):1510-30. doi: 10.1249/MSS.0b013e3181a0c95c.</citation>
    <PMID>19516148</PMID>
  </results_reference>
  <results_reference>
    <citation>Colado JC, Garcia-Masso X, Pellicer M, Alakhdar Y, Benavent J, Cabeza-Ruiz R. A comparison of elastic tubing and isotonic resistance exercises. Int J Sports Med. 2010 Nov;31(11):810-7. doi: 10.1055/s-0030-1262808. Epub 2010 Aug 11.</citation>
    <PMID>20703977</PMID>
  </results_reference>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>May 11, 2015</last_update_submitted>
  <last_update_submitted_qc>May 11, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Brasilia</investigator_affiliation>
    <investigator_full_name>Wagner Rodrigues Martins</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Aging</keyword>
  <keyword>Resistance training</keyword>
  <keyword>Muscle strength</keyword>
  <keyword>Functional performance</keyword>
  <keyword>Postural balance</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02253615
org study id: ERT-2014
nct id: NCT02253615
lead sponsor: 
has dmc: Yes
The latest randomized controlled trials and systematic reviews of resistance training
      performed by older adults reported that the systematic use of exercise in machines improves
      muscle strength and power, functional abilities, body mass and body balance. However, the
      effect of resistance training with elastic tubes exercises have not been studied in all the
      variables described above. The objective of this study is to analyze the effects of elastic
      tubes exercises on muscle mass, muscle strength, functional performance and postural control
      in elderly untrained.
This is a randomized clinical trial study (RCT) with 2 parallel arms. The subjects will be
      divided in 2 groups with a randomized block technique: Elastic Training Group (ETG) and
      Machine Training Group (MTG). The subjects will be submitted to a two-week familiarization
      period and then a sixteen-week of strength training program will be performed twice a week.

      This regimen of resistance training in both groups will consist of four exercises for lower
      limbs and four exercises for upper limbs which will be alternately performed with a
      one-minute interval between them during familiarization and training periods. Lower limb
      exercises will consist of: hip extension and abduction, and knee flexion and extension. Upper
      limb exercises will consist of: bench press, rowing, triceps and high pulley exercise.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Body Mass
time frame: Change from baseline in body mass at 16 weeks.
description: To assess muscle mass, a Dual-energy X-ray Absortiometry (DXA) (GE Electric Company®, Lunar Prodigy) will be used.
measure: Change in Muscle Strength
time frame: Change from baseline in muscle strength at 16 weeks.
description: Lower limb muscle strength will be assessed with an isokinetic dynamometer (Biodex System®, model III) and upper limb muscle strength with an isometric dynamometer (Jamar®, Hand Dynamometer).
measure: Change in Postural Balance
time frame: Change from baseline in postural balance at 16 weeks.
description: The postural balance will be assessed with a three-dimensional (3D) motion analysis system and force plates.
measure: Change in Functional performance
time frame: Before and after 16 weeks of resistance training
description: The functional performance will be assessed with Ten Meters Walk Test (TMW), Timed Up&Go Test (TUG) and 30 Second Chair Stand Test (T30).
arm group label: Machine resistance training (MRT)
arm group type: Active Comparator
description: The machine resistance training will consist of four exercises for lower limbs and four exercises for upper limbs which will be alternately performed with a one-minute interval between them during familiarization and training periods. Lower limb exercises will consist of: hip extension and abduction, and knee flexion and extension. Upper limb exercises will consist of: bench press, rowing, triceps and high pulley exercise.
arm group label: Elastic resistance training (ERT)
arm group type: Experimental
description: The elastic resistance training will consist of four exercises for lower limbs and four exercises for upper limbs which will be alternately performed with a one-minute interval between them during familiarization and training periods. Lower limb exercises will consist of: hip extension and abduction, and knee flexion and extension. Upper limb exercises will consist of: bench press, rowing, triceps and high pulley exercise.
intervention type: Other
intervention name: Machines exercises
description: Resistance training in pneumatic machines.
arm group label: Machine resistance training (MRT)
intervention type: Other
intervention name: Elastic exercises
description: Resistance training with elastic tubes.
arm group label: Elastic resistance training (ERT)
criteria: 
gender: All
minimum age: 55 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Brazil
citation: Lorenz DS. Variable resistance training using elastic bands to enhance lower extremity strengthening. Int J Sports Phys Ther. 2014 May;9(3):410-4.
PMID: 24944861
citation: Joy JM, Lowery RP, Oliveira de Souza E, Wilson JM. Elastic Bands as a Component of Periodized Resistance Training. J Strength Cond Res. 2016 Aug;30(8):2100-6. doi: 10.1519/JSC.0b013e3182986bef.
PMID: 23669815
citation: Martins WR, de Oliveira RJ, Carvalho RS, de Oliveira Damasceno V, da Silva VZ, Silva MS. Elastic resistance training to increase muscle strength in elderly: a systematic review with meta-analysis. Arch Gerontol Geriatr. 2013 Jul-Aug;57(1):8-15. doi: 10.1016/j.archger.2013.03.002. Epub 2013 Apr 4.
PMID: 23562413
citation: American College of Sports Medicine; Chodzko-Zajko WJ, Proctor DN, Fiatarone Singh MA, Minson CT, Nigg CR, Salem GJ, Skinner JS. American College of Sports Medicine position stand. Exercise and physical activity for older adults. Med Sci Sports Exerc. 2009 Jul;41(7):1510-30. doi: 10.1249/MSS.0b013e3181a0c95c.
PMID: 19516148
citation: Colado JC, Garcia-Masso X, Pellicer M, Alakhdar Y, Benavent J, Cabeza-Ruiz R. A comparison of elastic tubing and isotonic resistance exercises. Int J Sports Med. 2010 Nov;31(11):810-7. doi: 10.1055/s-0030-1262808. Epub 2010 Aug 11.
PMID: 20703977
responsible party type: Principal Investigator
investigator affiliation: University of Brasilia
investigator full name: Wagner Rodrigues Martins
investigator title: PhD