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Muscle Strength Training for Older Adults With Type II Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03280758
Recruitment Status : Unknown
Verified September 2017 by Shirley S.M. Fong, The University of Hong Kong.
Recruitment status was:  Not yet recruiting
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Shirley S.M. Fong, The University of Hong Kong

Study Description
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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).


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: Muscle Strengthening exercises Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The outcome assessor will not know the intervention of each subjects
Primary Purpose: Treatment
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
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Muscle strengthening group
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.
 Behavioral: Muscle Strengthening exercises
Participants will be required to participate in resistance training 3 hours per week.
No Intervention: Control group
No exercise training.


Outcome Measures
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Primary Outcome Measures :
  1. Fasting glucose level [ Time Frame: 4 months ]
  2. Lipid profiles [ Time Frame: 4 months ]
    HDL, LDL, Trig


Secondary Outcome Measures :
  1. Muscle strength [ Time Frame: 4 months ]
    Whole body

  2. Muscle mass [ Time Frame: 4 months ]
    Whole body

  3. Functional performance [ Time Frame: 4 months ]
    Walking ability


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280758


Contacts
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Contact: Siu Ming Fong, PhD 28315260 smfong@hku.hk

Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Siu Ming Fong, PhD The University of Hong Kong
More Information
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Publications:

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Responsible Party: Shirley S.M. Fong, Dr, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03280758    
Other Study ID Numbers: 02
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shirley S.M. Fong, The University of Hong Kong:
Resistance training
Diabetes Mellitus
blood-glucose control
Muscle
Function
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases