<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/NCT03280758</url>
  </required_header>
  <id_info>
    <org_study_id>02</org_study_id>
    <nct_id>NCT03280758</nct_id>
  </id_info>
  <brief_title>Muscle Strength Training for Older Adults With Type II Diabetes</brief_title>
  <official_title>Effects of Muscle Strength Training on Glycemic Control, Muscle Mass, Muscle Strength and Functional Capacity in Older Adults With Type II Diabetes: A Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomised controlled trial aims to investigate a resistance training program for&#xD;
      improving glycemic control, muscle mass, strength and functional performance in older&#xD;
      patients with Type II Diabetes (T2 DM).&#xD;
&#xD;
      60 subjects will be randomly allocated to either a muscle strengthening group or a no&#xD;
      exercise control group.&#xD;
&#xD;
      Muscle strengthening group will receive resistance training 3 times per week (1&#xD;
      hour/session).&#xD;
&#xD;
      The control group will not receive any training but can continue usual medical care and daily&#xD;
      activities.&#xD;
&#xD;
      Primary outcomes: glycemic control and lipid profile Secondary outcomes: muscle mass and&#xD;
      strength, and functional capacity Data will be collected at baseline (pre-test) and after a&#xD;
      4-month intervention (post-test).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to investigate a resistance training program for improving glycemic control,&#xD;
      muscle mass, strength and functional performance in older patients with Type II Diabetes (T2&#xD;
      DM).&#xD;
&#xD;
      This is a single-blinded, randomized controlled trial. 60 subjects will be randomly allocated&#xD;
      to either a muscle strengthening group or a no exercise control group.&#xD;
&#xD;
      Information on demographic characteristics, body composition, muscle strength, functional&#xD;
      capacity and glycemic control will be collected at baseline (pre-test) and after a 4-month&#xD;
      intervention (post-test). Muscle strengthening group will receive resistance training 3 times&#xD;
      per week (1 hour/session).&#xD;
&#xD;
      The control group will not receive any training but can continue usual medical care and daily&#xD;
      activities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">August 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 30, 2019</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>
    <masking_description>The outcome assessor will not know the intervention of each subjects</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Fasting glucose level</measure>
    <time_frame>4 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Lipid profiles</measure>
    <time_frame>4 months</time_frame>
    <description>HDL, LDL, Trig</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>4 months</time_frame>
    <description>Whole body</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle mass</measure>
    <time_frame>4 months</time_frame>
    <description>Whole body</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional performance</measure>
    <time_frame>4 months</time_frame>
    <description>Walking ability</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Muscle strengthening group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be required to perform muscle strengthening exercises 3 hours per week. Close kinetic chain exercises will be performed progressively according to the ACSM guidelines over the 4-month intervention period. The exercise intervention will be conducted by an experienced sports trainer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No exercise training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Muscle Strengthening exercises</intervention_name>
    <description>Participants will be required to participate in resistance training 3 hours per week.</description>
    <arm_group_label>Muscle strengthening group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  T2 DM&#xD;
&#xD;
          -  60-75 years old&#xD;
&#xD;
          -  ability to perform exercise&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Advanced hypertension (≥ 160/100 mm Hg)&#xD;
&#xD;
          -  severe obesity (BMI ≥ 48kg/m2)&#xD;
&#xD;
          -  insulin pump user&#xD;
&#xD;
          -  coronary heart disease history&#xD;
&#xD;
          -  chronic obstructive pulmonary disease&#xD;
&#xD;
          -  advanced neuropathy&#xD;
&#xD;
          -  learning or mental disorder, or&#xD;
&#xD;
          -  any other diseases that prevent subjects from exercising safely.&#xD;
&#xD;
          -  Those who participate in regular resistance or aerobic exercises will also be&#xD;
             excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Siu Ming Fong, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Siu Ming Fong, PhD</last_name>
    <phone>28315260</phone>
    <email>smfong@hku.hk</email>
  </overall_contact>
  <reference>
    <citation>Nolan CJ, Damm P, Prentki M. Type 2 diabetes across generations: from pathophysiology to prevention and management. Lancet. 2011 Jul 9;378(9786):169-81. doi: 10.1016/S0140-6736(11)60614-4. Epub 2011 Jun 24.</citation>
    <PMID>21705072</PMID>
  </reference>
  <reference>
    <citation>Leenders M, Verdijk LB, van der Hoeven L, Adam JJ, van Kranenburg J, Nilwik R, van Loon LJ. Patients with type 2 diabetes show a greater decline in muscle mass, muscle strength, and functional capacity with aging. J Am Med Dir Assoc. 2013 Aug;14(8):585-92. doi: 10.1016/j.jamda.2013.02.006. Epub 2013 Mar 26.</citation>
    <PMID>23537893</PMID>
  </reference>
  <reference>
    <citation>Shishikura K, Tanimoto K, Sakai S, Tanimoto Y, Terasaki J, Hanafusa T. Association between skeletal muscle mass and insulin secretion in patients with type 2 diabetes mellitus. Endocr J. 2014;61(3):281-7. doi: 10.1507/endocrj.ej13-0375. Epub 2014 Jan 10.</citation>
    <PMID>24420336</PMID>
  </reference>
  <reference>
    <citation>Dunstan DW, Daly RM, Owen N, Jolley D, De Courten M, Shaw J, Zimmet P. High-intensity resistance training improves glycemic control in older patients with type 2 diabetes. Diabetes Care. 2002 Oct;25(10):1729-36. doi: 10.2337/diacare.25.10.1729.</citation>
    <PMID>12351469</PMID>
  </reference>
  <reference>
    <citation>American Diabetes Association. Diabetes mellitus and exercise. Diabetes Care. 2000 Jan;23 Suppl 1:S50-4. No abstract available.</citation>
    <PMID>12017678</PMID>
  </reference>
  <reference>
    <citation>Albright A, Franz M, Hornsby G, Kriska A, Marrero D, Ullrich I, Verity LS. American College of Sports Medicine position stand. Exercise and type 2 diabetes. Med Sci Sports Exerc. 2000 Jul;32(7):1345-60. doi: 10.1097/00005768-200007000-00024.</citation>
    <PMID>10912903</PMID>
  </reference>
  <reference>
    <citation>Black LE, Swan PD, Alvar BA. Effects of intensity and volume on insulin sensitivity during acute bouts of resistance training. J Strength Cond Res. 2010 Apr;24(4):1109-16. doi: 10.1519/JSC.0b013e3181cbab6d.</citation>
    <PMID>20093961</PMID>
  </reference>
  <reference>
    <citation>Baldi JC, Snowling N. Resistance training improves glycaemic control in obese type 2 diabetic men. Int J Sports Med. 2003 Aug;24(6):419-23. doi: 10.1055/s-2003-41173.</citation>
    <PMID>12905089</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 11, 2017</last_update_submitted>
  <last_update_submitted_qc>September 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Shirley S.M. Fong</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>Resistance training</keyword>
  <keyword>Diabetes Mellitus</keyword>
  <keyword>blood-glucose control</keyword>
  <keyword>Muscle</keyword>
  <keyword>Function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03280758
org study id: 02
nct id: NCT03280758
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This randomised controlled trial aims to investigate a resistance training program for
      improving glycemic control, muscle mass, strength and functional performance in older
      patients with Type II Diabetes (T2 DM).

      60 subjects will be randomly allocated to either a muscle strengthening group or a no
      exercise control group.

      Muscle strengthening group will receive resistance training 3 times per week (1
      hour/session).

      The control group will not receive any training but can continue usual medical care and daily
      activities.

      Primary outcomes: glycemic control and lipid profile Secondary outcomes: muscle mass and
      strength, and functional capacity Data will be collected at baseline (pre-test) and after a
      4-month intervention (post-test).
This study aims to investigate a resistance training program for improving glycemic control,
      muscle mass, strength and functional performance in older patients with Type II Diabetes (T2
      DM).

      This is a single-blinded, randomized controlled trial. 60 subjects will be randomly allocated
      to either a muscle strengthening group or a no exercise control group.

      Information on demographic characteristics, body composition, muscle strength, functional
      capacity and glycemic control will be collected at baseline (pre-test) and after a 4-month
      intervention (post-test). Muscle strengthening group will receive resistance training 3 times
      per week (1 hour/session).

      The control group will not receive any training but can continue usual medical care and daily
      activities.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The outcome assessor will not know the intervention of each subjects
measure: Fasting glucose level
time frame: 4 months
measure: Lipid profiles
time frame: 4 months
description: HDL, LDL, Trig
measure: Muscle strength
time frame: 4 months
description: Whole body
measure: Muscle mass
time frame: 4 months
description: Whole body
measure: Functional performance
time frame: 4 months
description: Walking ability
arm group label: Muscle strengthening group
arm group type: Experimental
description: Participants will be required to perform muscle strengthening exercises 3 hours per week. Close kinetic chain exercises will be performed progressively according to the ACSM guidelines over the 4-month intervention period. The exercise intervention will be conducted by an experienced sports trainer.
arm group label: Control group
arm group type: No Intervention
description: No exercise training.
intervention type: Behavioral
intervention name: Muscle Strengthening exercises
description: Participants will be required to participate in resistance training 3 hours per week.
arm group label: Muscle strengthening group
criteria: 
gender: All
minimum age: 60 Years
maximum age: 75 Years
healthy volunteers: No
last name: Siu Ming Fong, PhD
role: Principal Investigator
affiliation: The University of Hong Kong
last name: Siu Ming Fong, PhD
phone: 28315260
email: smfong@hku.hk
citation: Nolan CJ, Damm P, Prentki M. Type 2 diabetes across generations: from pathophysiology to prevention and management. Lancet. 2011 Jul 9;378(9786):169-81. doi: 10.1016/S0140-6736(11)60614-4. Epub 2011 Jun 24.
PMID: 21705072
citation: Leenders M, Verdijk LB, van der Hoeven L, Adam JJ, van Kranenburg J, Nilwik R, van Loon LJ. Patients with type 2 diabetes show a greater decline in muscle mass, muscle strength, and functional capacity with aging. J Am Med Dir Assoc. 2013 Aug;14(8):585-92. doi: 10.1016/j.jamda.2013.02.006. Epub 2013 Mar 26.
PMID: 23537893
citation: Shishikura K, Tanimoto K, Sakai S, Tanimoto Y, Terasaki J, Hanafusa T. Association between skeletal muscle mass and insulin secretion in patients with type 2 diabetes mellitus. Endocr J. 2014;61(3):281-7. doi: 10.1507/endocrj.ej13-0375. Epub 2014 Jan 10.
PMID: 24420336
citation: Dunstan DW, Daly RM, Owen N, Jolley D, De Courten M, Shaw J, Zimmet P. High-intensity resistance training improves glycemic control in older patients with type 2 diabetes. Diabetes Care. 2002 Oct;25(10):1729-36. doi: 10.2337/diacare.25.10.1729.
PMID: 12351469
citation: American Diabetes Association. Diabetes mellitus and exercise. Diabetes Care. 2000 Jan;23 Suppl 1:S50-4. No abstract available.
PMID: 12017678
citation: Albright A, Franz M, Hornsby G, Kriska A, Marrero D, Ullrich I, Verity LS. American College of Sports Medicine position stand. Exercise and type 2 diabetes. Med Sci Sports Exerc. 2000 Jul;32(7):1345-60. doi: 10.1097/00005768-200007000-00024.
PMID: 10912903
citation: Black LE, Swan PD, Alvar BA. Effects of intensity and volume on insulin sensitivity during acute bouts of resistance training. J Strength Cond Res. 2010 Apr;24(4):1109-16. doi: 10.1519/JSC.0b013e3181cbab6d.
PMID: 20093961
citation: Baldi JC, Snowling N. Resistance training improves glycaemic control in obese type 2 diabetic men. Int J Sports Med. 2003 Aug;24(6):419-23. doi: 10.1055/s-2003-41173.
PMID: 12905089
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Shirley S.M. Fong
investigator title: Dr
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No