Resistance Training in Diabetic Elder Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01638351
First received: July 8, 2012
Last updated: November 15, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Behavioral: Resistance exercise
Behavioral: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Resistance Training on Muscle Dysfunction in Elderly Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Maximal muscle strength [ Time Frame: Twelve weeks ] [ Designated as safety issue: No ]
    This outcome measure includes upper and lower body maximal muscle strength.


Secondary Outcome Measures:
  • Physical body function [ Time Frame: Twelve weeks ] [ Designated as safety issue: No ]
    This outcome will be assessed by one minute sit-to-stand test and timed "Up and Go" test.

  • Quality of life [ Time Frame: Twelve weeks ] [ Designated as safety issue: No ]
    This outcome measure will be assessed by the diabetes-specific questionnaire.

  • Waist circumference [ Time Frame: Twelve weeks ] [ Designated as safety issue: No ]
  • Body mass index [ Time Frame: Twelve weeks ] [ Designated as safety issue: No ]
    This outcome measure includes the measurements of body height and body weight.

  • Functional capacity [ Time Frame: Twelve weeks ] [ Designated as safety issue: No ]
    Peak oxygen consumption will be determined by graded exercise test to assess functional capacity.

  • Blood biochemical parameters [ Time Frame: Twevle weeks ] [ Designated as safety issue: No ]
    This outcome measure includes the analysis of fasting glucose, glycated hemoglobin, lipid profile, C-reactive protein, and related metabolites.

  • Muscle oxygenation [ Time Frame: Twelve weeks ] [ Designated as safety issue: No ]
    Muscle oxygenation will be assessed during exercise


Enrollment: 49
Study Start Date: December 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01638351

Locations
Taiwan
National Taiwan University Hospital
Taipei City, Taiwan, 100
Sponsors and Collaborators
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.)
  More Information

Publications:
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01638351     History of Changes
Other Study ID Numbers: 201110029RC
Study First Received: July 8, 2012
Last Updated: November 15, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Diabetes mellitus
Resistance exercise
Elderly
Skeletal muscle dysfunction
Metabolomics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 14, 2014