<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/NCT03282175</url>
  </required_header>
  <id_info>
    <org_study_id>UP-FVZ-ERT-Myokine</org_study_id>
    <nct_id>NCT03282175</nct_id>
  </id_info>
  <brief_title>Effects of Elastic Resistance Training on Performance and Biochemical Parameters</brief_title>
  <official_title>Effects of Elastic Resistance Training on Physical Performance, Inflammatory Marker and Myokines in Elderly Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Primorska</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Primorska</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to investigate the acute and chronic effect of elastic resistance&#xD;
      exercise in elderly women living in a nursing home. The primary outcome was the functional&#xD;
      performance and hand grip strength. The secondary outcomes were myokines and inflammatory&#xD;
      markers analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evidence regarding the relationship between RT and systemic myokine responses, as well as&#xD;
      inflammation and physical performance in elderly is limited. Thus, this study aimed to&#xD;
      evaluate the effect of short-term progressive elastic resistance training on muscular&#xD;
      strength and physical performance, as well as the acute and chronic response of myokines and&#xD;
      inflammatory markers after resistance exercise in elderly women living in a nursing home.&#xD;
      From January to February 2016, we invited 95 older women (≥ 65 years) living in nursing home&#xD;
      in the south of Slovenia to participate in our study.&#xD;
&#xD;
      The experimental design consisted of 1) baseline testing; 2) acute elastic resistance&#xD;
      exercises with post-exercise and 2h post-exercise biochemical analysis; 3) a 3 months of&#xD;
      supervised, progressive elastic resistance training program of moderate intensity; and 4)&#xD;
      post-training testing.&#xD;
&#xD;
      The quantification of biomarkers was done using the MAGPIX® system, magnetic bead-based&#xD;
      multi-analyte panels and MILLIPLEX® Analyst 5.1 software (MAGPIX®, Merck Millipore) and a&#xD;
      human premixed 4-plex kit (R&amp;D System Inc., Minneapolis, MN, USA), strictly following the&#xD;
      manufacturer's instructions.&#xD;
&#xD;
      Two-way mixed ANOVA model was used to test group × time interaction. Tukey's post hoc test&#xD;
      was applied for statistically significant interaction. To test for significant differences&#xD;
      between groups relating anthropometric and biochemical variables, we used a Student's t-test.&#xD;
      All values are expressed as mean and standard deviation (SD). P values of &lt;0.05 is considered&#xD;
      statistically significant. Bonferroni's correction for multiple testing will be performed by&#xD;
      multiplying the P value with the number of tests where appropriate. Statistical analyses will&#xD;
      be carried out using the SPSS program, version 21 (Chicago, IL).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2016</start_date>
  <completion_date type="Actual">June 30, 2016</completion_date>
  <primary_completion_date type="Actual">June 30, 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional performance</measure>
    <time_frame>1 week</time_frame>
    <description>A short battery of physical performance tests (SPPB) was used to assess baseline and post-training lower extremity function (0-12 point scale).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acute effect of resistance exercise</measure>
    <time_frame>4 hours</time_frame>
    <description>The acute effect of resistance exercise on plasma concentrations of myokines and inflammatory markers measured pre-, post- and 2h post-exercise.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemical analysis of chronic effect of resistance training</measure>
    <time_frame>2 weeks</time_frame>
    <description>The chronic effect of resistance training on plasma concentrations of myokines and inflammatory markers measured at baseline and post-training.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Exercise</condition>
  <arm_group>
    <arm_group_label>Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant in this group performed an acute resistance exercise protocol. The exercise protocol consisted of general warm-up of 10 min, followed by 8 exercises with 2 sets of 8 repetition and 1 min between sets.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants allocated to intervention group initiated the progressive resistance training program of moderate intensity, with three weekly sessions throughout the 12-week treatment period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants allocated to control group did not receive any placebo or treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Exercise session consisted of general warm-up of 10 min, followed by 35-40 min of resistance exercises (chair squats, band seated: biceps curl, seated row, knee extension, leg press and hip abduction; standing behind the chair: knee flexion, and calf rise), and general cool down of 10 min.</description>
    <arm_group_label>Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Training</intervention_name>
    <description>Each training session consisted of general warm-up of 10 min, followed by 35-40 min of resistance exercises (chair squats, band seated: biceps curl, seated row, knee extension, leg press and hip abduction; standing behind the chair: knee flexion, and calf rise), and general cool down of 10 min.</description>
    <arm_group_label>Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>The control group did not receive any treatment.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  nursing home residents&#xD;
&#xD;
          -  participants did not perform any regular resistance training&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  immobility&#xD;
&#xD;
          -  implantable cardiac peacemaker&#xD;
&#xD;
          -  severe dementia&#xD;
&#xD;
          -  terminal illness&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female nursing home residents</gender_description>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Felicita Urzi, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Primorska Faculty of Mathematics, Natural Sciences and Information Technologies</affiliation>
  </overall_official>
  <reference>
    <citation>Argiles JM, Lopez-Soriano FJ, Busquets S. Therapeutic potential of interleukin-15: a myokine involved in muscle wasting and adiposity. Drug Discov Today. 2009 Feb;14(3-4):208-13. doi: 10.1016/j.drudis.2008.10.010. Epub 2008 Dec 16.</citation>
    <PMID>19041416</PMID>
  </reference>
  <reference>
    <citation>Busquets S, Figueras M, Almendro V, Lopez-Soriano FJ, Argiles JM. Interleukin-15 increases glucose uptake in skeletal muscle. An antidiabetogenic effect of the cytokine. Biochim Biophys Acta. 2006 Nov;1760(11):1613-7. doi: 10.1016/j.bbagen.2006.09.001. Epub 2006 Sep 12.</citation>
    <PMID>17056184</PMID>
  </reference>
  <reference>
    <citation>Geroldi D, Minoretti P, Emanuele E. Brain-derived neurotrophic factor and the metabolic syndrome: more than just a hypothesis. Med Hypotheses. 2006;67(1):195-6. doi: 10.1016/j.mehy.2006.02.001. Epub 2006 Mar 20. No abstract available.</citation>
    <PMID>16545915</PMID>
  </reference>
  <reference>
    <citation>Martins WR, Safons MP, Bottaro M, Blasczyk JC, Diniz LR, Fonseca RM, Bonini-Rocha AC, de Oliveira RJ. Effects of short term elastic resistance training on muscle mass and strength in untrained older adults: a randomized clinical trial. BMC Geriatr. 2015 Aug 12;15:99. doi: 10.1186/s12877-015-0101-5.</citation>
    <PMID>26265075</PMID>
  </reference>
  <reference>
    <citation>Oesen S, Halper B, Hofmann M, Jandrasits W, Franzke B, Strasser EM, Graf A, Tschan H, Bachl N, Quittan M, Wagner KH, Wessner B. Effects of elastic band resistance training and nutritional supplementation on physical performance of institutionalised elderly--A randomized controlled trial. Exp Gerontol. 2015 Dec;72:99-108. doi: 10.1016/j.exger.2015.08.013. Epub 2015 Sep 2.</citation>
    <PMID>26341720</PMID>
  </reference>
  <reference>
    <citation>Prestes J, Shiguemoto G, Botero JP, Frollini A, Dias R, Leite R, Pereira G, Magosso R, Baldissera V, Cavaglieri C, Perez S. Effects of resistance training on resistin, leptin, cytokines, and muscle force in elderly post-menopausal women. J Sports Sci. 2009 Dec;27(14):1607-15. doi: 10.1080/02640410903352923.</citation>
    <PMID>19967592</PMID>
  </reference>
  <reference>
    <citation>Pereira DS, de Queiroz BZ, Miranda AS, Rocha NP, Felicio DC, Mateo EC, Favero M, Coelho FM, Jesus-Moraleida F, Gomes Pereira DA, Teixeira AL, Maximo Pereira LS. Effects of physical exercise on plasma levels of brain-derived neurotrophic factor and depressive symptoms in elderly women--a randomized clinical trial. Arch Phys Med Rehabil. 2013 Aug;94(8):1443-50. doi: 10.1016/j.apmr.2013.03.029. Epub 2013 Apr 18.</citation>
    <PMID>23602881</PMID>
  </reference>
  <reference>
    <citation>Troseid M, Lappegard KT, Claudi T, Damas JK, Morkrid L, Brendberg R, Mollnes TE. Exercise reduces plasma levels of the chemokines MCP-1 and IL-8 in subjects with the metabolic syndrome. Eur Heart J. 2004 Feb;25(4):349-55. doi: 10.1016/j.ehj.2003.12.006.</citation>
    <PMID>14984925</PMID>
  </reference>
  <reference>
    <citation>Yeo NH, Woo J, Shin KO, Park JY, Kang S. The effects of different exercise intensity on myokine and angiogenesis factors. J Sports Med Phys Fitness. 2012 Aug;52(4):448-54.</citation>
    <PMID>22828466</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>September 26, 2017</last_update_submitted>
  <last_update_submitted_qc>September 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>BDNF</keyword>
  <keyword>interleukin-15</keyword>
  <keyword>interleukin-8</keyword>
  <keyword>resistin</keyword>
  <keyword>SPPB</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/NCT03282175
org study id: UP-FVZ-ERT-Myokine
nct id: NCT03282175
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to investigate the acute and chronic effect of elastic resistance
      exercise in elderly women living in a nursing home. The primary outcome was the functional
      performance and hand grip strength. The secondary outcomes were myokines and inflammatory
      markers analysis.
Evidence regarding the relationship between RT and systemic myokine responses, as well as
      inflammation and physical performance in elderly is limited. Thus, this study aimed to
      evaluate the effect of short-term progressive elastic resistance training on muscular
      strength and physical performance, as well as the acute and chronic response of myokines and
      inflammatory markers after resistance exercise in elderly women living in a nursing home.
      From January to February 2016, we invited 95 older women (≥ 65 years) living in nursing home
      in the south of Slovenia to participate in our study.

      The experimental design consisted of 1) baseline testing; 2) acute elastic resistance
      exercises with post-exercise and 2h post-exercise biochemical analysis; 3) a 3 months of
      supervised, progressive elastic resistance training program of moderate intensity; and 4)
      post-training testing.

      The quantification of biomarkers was done using the MAGPIX® system, magnetic bead-based
      multi-analyte panels and MILLIPLEX® Analyst 5.1 software (MAGPIX®, Merck Millipore) and a
      human premixed 4-plex kit (R&D System Inc., Minneapolis, MN, USA), strictly following the
      manufacturer's instructions.

      Two-way mixed ANOVA model was used to test group × time interaction. Tukey's post hoc test
      was applied for statistically significant interaction. To test for significant differences
      between groups relating anthropometric and biochemical variables, we used a Student's t-test.
      All values are expressed as mean and standard deviation (SD). P values of <0.05 is considered
      statistically significant. Bonferroni's correction for multiple testing will be performed by
      multiplying the P value with the number of tests where appropriate. Statistical analyses will
      be carried out using the SPSS program, version 21 (Chicago, IL).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Functional performance
time frame: 1 week
description: A short battery of physical performance tests (SPPB) was used to assess baseline and post-training lower extremity function (0-12 point scale).
measure: Acute effect of resistance exercise
time frame: 4 hours
description: The acute effect of resistance exercise on plasma concentrations of myokines and inflammatory markers measured pre-, post- and 2h post-exercise.
measure: Biochemical analysis of chronic effect of resistance training
time frame: 2 weeks
description: The chronic effect of resistance training on plasma concentrations of myokines and inflammatory markers measured at baseline and post-training.
arm group label: Exercise
arm group type: Experimental
description: Participant in this group performed an acute resistance exercise protocol. The exercise protocol consisted of general warm-up of 10 min, followed by 8 exercises with 2 sets of 8 repetition and 1 min between sets.
arm group label: Training
arm group type: Experimental
description: Participants allocated to intervention group initiated the progressive resistance training program of moderate intensity, with three weekly sessions throughout the 12-week treatment period.
arm group label: Control group
arm group type: Active Comparator
description: Participants allocated to control group did not receive any placebo or treatment.
intervention type: Other
intervention name: Exercise
description: Exercise session consisted of general warm-up of 10 min, followed by 35-40 min of resistance exercises (chair squats, band seated: biceps curl, seated row, knee extension, leg press and hip abduction; standing behind the chair: knee flexion, and calf rise), and general cool down of 10 min.
arm group label: Exercise
intervention type: Other
intervention name: Training
description: Each training session consisted of general warm-up of 10 min, followed by 35-40 min of resistance exercises (chair squats, band seated: biceps curl, seated row, knee extension, leg press and hip abduction; standing behind the chair: knee flexion, and calf rise), and general cool down of 10 min.
arm group label: Training
intervention type: Other
intervention name: Control group
description: The control group did not receive any treatment.
arm group label: Control group
criteria: 
gender: Female
gender based: Yes
gender description: Female nursing home residents
minimum age: 65 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Felicita Urzi, MSc
role: Principal Investigator
affiliation: University of Primorska Faculty of Mathematics, Natural Sciences and Information Technologies
citation: Argiles JM, Lopez-Soriano FJ, Busquets S. Therapeutic potential of interleukin-15: a myokine involved in muscle wasting and adiposity. Drug Discov Today. 2009 Feb;14(3-4):208-13. doi: 10.1016/j.drudis.2008.10.010. Epub 2008 Dec 16.
PMID: 19041416
citation: Busquets S, Figueras M, Almendro V, Lopez-Soriano FJ, Argiles JM. Interleukin-15 increases glucose uptake in skeletal muscle. An antidiabetogenic effect of the cytokine. Biochim Biophys Acta. 2006 Nov;1760(11):1613-7. doi: 10.1016/j.bbagen.2006.09.001. Epub 2006 Sep 12.
PMID: 17056184
citation: Geroldi D, Minoretti P, Emanuele E. Brain-derived neurotrophic factor and the metabolic syndrome: more than just a hypothesis. Med Hypotheses. 2006;67(1):195-6. doi: 10.1016/j.mehy.2006.02.001. Epub 2006 Mar 20. No abstract available.
PMID: 16545915
citation: Martins WR, Safons MP, Bottaro M, Blasczyk JC, Diniz LR, Fonseca RM, Bonini-Rocha AC, de Oliveira RJ. Effects of short term elastic resistance training on muscle mass and strength in untrained older adults: a randomized clinical trial. BMC Geriatr. 2015 Aug 12;15:99. doi: 10.1186/s12877-015-0101-5.
PMID: 26265075
citation: Oesen S, Halper B, Hofmann M, Jandrasits W, Franzke B, Strasser EM, Graf A, Tschan H, Bachl N, Quittan M, Wagner KH, Wessner B. Effects of elastic band resistance training and nutritional supplementation on physical performance of institutionalised elderly--A randomized controlled trial. Exp Gerontol. 2015 Dec;72:99-108. doi: 10.1016/j.exger.2015.08.013. Epub 2015 Sep 2.
PMID: 26341720
citation: Prestes J, Shiguemoto G, Botero JP, Frollini A, Dias R, Leite R, Pereira G, Magosso R, Baldissera V, Cavaglieri C, Perez S. Effects of resistance training on resistin, leptin, cytokines, and muscle force in elderly post-menopausal women. J Sports Sci. 2009 Dec;27(14):1607-15. doi: 10.1080/02640410903352923.
PMID: 19967592
citation: Pereira DS, de Queiroz BZ, Miranda AS, Rocha NP, Felicio DC, Mateo EC, Favero M, Coelho FM, Jesus-Moraleida F, Gomes Pereira DA, Teixeira AL, Maximo Pereira LS. Effects of physical exercise on plasma levels of brain-derived neurotrophic factor and depressive symptoms in elderly women--a randomized clinical trial. Arch Phys Med Rehabil. 2013 Aug;94(8):1443-50. doi: 10.1016/j.apmr.2013.03.029. Epub 2013 Apr 18.
PMID: 23602881
citation: Troseid M, Lappegard KT, Claudi T, Damas JK, Morkrid L, Brendberg R, Mollnes TE. Exercise reduces plasma levels of the chemokines MCP-1 and IL-8 in subjects with the metabolic syndrome. Eur Heart J. 2004 Feb;25(4):349-55. doi: 10.1016/j.ehj.2003.12.006.
PMID: 14984925
citation: Yeo NH, Woo J, Shin KO, Park JY, Kang S. The effects of different exercise intensity on myokine and angiogenesis factors. J Sports Med Phys Fitness. 2012 Aug;52(4):448-54.
PMID: 22828466
responsible party type: Sponsor