Resistance Training in Diabetic Elder Patients

November 15, 2012 updated by: National Taiwan University Hospital

Effects of Resistance Training on Muscle Dysfunction in Elderly Patients With Type 2 Diabetes Mellitus

The purpose of this study is to investigate the effect of a 12-week progressive resistance training program on the skeletal muscle function, glycemic control, functional capacity, and quality of life in the elderly with type 2 diabetes mellitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei City, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 65 years old or older
  • no clinical diagnosis of cardiovascular disease
  • patients with or without type 2 diabetes mellitus

Exclusion Criteria:

  • glycated hemoglobin > 10%
  • pulmonary disease
  • cancer
  • cognitive dysfunction
  • any neurological or musculoskeletal disease that will affect exercise performance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Usual care
Participants in this arm will receive a brochure specific for type 2 diabetes mellitus about the general principles of exercise, nutrition, and diet. They are asked to maintain their activity level.
Behavioral: Usual care
Participants in this arm will receive a brochure specific for type 2 diabetes mellitus about the general principles of exercise, nutrition, and diet. They are asked to maintain their activity level.
EXPERIMENTAL: Resistance exercise
Progressive resistance training, 3 times a week for 12 weeks
Behavioral: Resistance exercise
Progressive resistance exercise training, 3 times a week for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal muscle strength
Time Frame: Twelve weeks
This outcome measure includes upper and lower body maximal muscle strength.
Twelve weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical body function
Time Frame: Twelve weeks
This outcome will be assessed by one minute sit-to-stand test and timed "Up and Go" test.
Twelve weeks
Quality of life
Time Frame: Twelve weeks
This outcome measure will be assessed by the diabetes-specific questionnaire.
Twelve weeks
Waist circumference
Time Frame: Twelve weeks
Twelve weeks
Body mass index
Time Frame: Twelve weeks
This outcome measure includes the measurements of body height and body weight.
Twelve weeks
Functional capacity
Time Frame: Twelve weeks
Peak oxygen consumption will be determined by graded exercise test to assess functional capacity.
Twelve weeks
Blood biochemical parameters
Time Frame: Twevle weeks
This outcome measure includes the analysis of fasting glucose, glycated hemoglobin, lipid profile, C-reactive protein, and related metabolites.
Twevle weeks
Muscle oxygenation
Time Frame: Twelve weeks
Muscle oxygenation will be assessed during exercise
Twelve weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Chair: Ying-Tai Wu, Ph.D., School and Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University (R.O.C.)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

July 8, 2012

First Submitted That Met QC Criteria

July 8, 2012

First Posted (ESTIMATE)

July 11, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 16, 2012

Last Update Submitted That Met QC Criteria

November 15, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201110029RC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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