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Muscle Strength Training for Older Adults With Type II Diabetes

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Muscle Strengthening exercises
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Resistance training, Diabetes Mellitus, blood-glucose control, Muscle, Function

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • T2 DM
  • 60-75 years old
  • ability to perform exercise

Exclusion Criteria:

  • Advanced hypertension (≥ 160/100 mm Hg)
  • severe obesity (BMI ≥ 48kg/m2)
  • insulin pump user
  • coronary heart disease history
  • chronic obstructive pulmonary disease
  • advanced neuropathy
  • learning or mental disorder, or
  • any other diseases that prevent subjects from exercising safely.
  • Those who participate in regular resistance or aerobic exercises will also be excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Muscle strengthening group

    Control group

    Arm 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.

    No exercise training.

    Outcomes

    Primary Outcome Measures

    Fasting glucose level
    Lipid profiles
    HDL, LDL, Trig

    Secondary Outcome Measures

    Muscle strength
    Whole body
    Muscle mass
    Whole body
    Functional performance
    Walking ability

    Full Information

    First Posted
    September 5, 2017
    Last Updated
    September 11, 2017
    Sponsor
    The University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03280758
    Brief Title
    Muscle Strength Training for Older Adults With Type II Diabetes
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2017 (Anticipated)
    Primary Completion Date
    January 30, 2019 (Anticipated)
    Study Completion Date
    August 30, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The University of Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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).
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Mellitus
    Keywords
    Resistance training, Diabetes Mellitus, blood-glucose control, Muscle, Function

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    The outcome assessor will not know the intervention of each subjects
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Muscle strengthening group
    Arm Type
    Experimental
    Arm 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 Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    No exercise training.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Muscle Strengthening exercises
    Intervention Description
    Participants will be required to participate in resistance training 3 hours per week.
    Primary Outcome Measure Information:
    Title
    Fasting glucose level
    Time Frame
    4 months
    Title
    Lipid profiles
    Description
    HDL, LDL, Trig
    Time Frame
    4 months
    Secondary Outcome Measure Information:
    Title
    Muscle strength
    Description
    Whole body
    Time Frame
    4 months
    Title
    Muscle mass
    Description
    Whole body
    Time Frame
    4 months
    Title
    Functional performance
    Description
    Walking ability
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: T2 DM 60-75 years old ability to perform exercise Exclusion Criteria: Advanced hypertension (≥ 160/100 mm Hg) severe obesity (BMI ≥ 48kg/m2) insulin pump user coronary heart disease history chronic obstructive pulmonary disease advanced neuropathy learning or mental disorder, or any other diseases that prevent subjects from exercising safely. Those who participate in regular resistance or aerobic exercises will also be excluded.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Siu Ming Fong, PhD
    Phone
    28315260
    Email
    smfong@hku.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Siu Ming Fong, PhD
    Organizational Affiliation
    The University of Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21705072
    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.
    Results Reference
    background
    PubMed Identifier
    23537893
    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.
    Results Reference
    background
    PubMed Identifier
    24420336
    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.
    Results Reference
    background
    PubMed Identifier
    12351469
    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.
    Results Reference
    background
    PubMed Identifier
    12017678
    Citation
    American Diabetes Association. Diabetes mellitus and exercise. Diabetes Care. 2000 Jan;23 Suppl 1:S50-4. No abstract available.
    Results Reference
    background
    PubMed Identifier
    10912903
    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.
    Results Reference
    background
    PubMed Identifier
    20093961
    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.
    Results Reference
    background
    PubMed Identifier
    12905089
    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.
    Results Reference
    background

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    Muscle Strength Training for Older Adults With Type II Diabetes

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