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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014