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Completed

NCT Number: NCT01638351

Resistance Training in Diabetic Elder Patients

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance exercise

Behavioral

Progressive resistance exercise training, 3 times a week for 12 weeks.

Usual Care

Behavioral

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.

Primary outcomes

  1. Maximal muscle strength

    Time frame: Twelve weeks

    This outcome measure includes upper and lower body maximal muscle strength.

Secondary outcomes

  1. 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.

  2. Quality of life

    Time frame: Twelve weeks

    This outcome measure will be assessed by the diabetes-specific questionnaire.

  3. Waist circumference

    Time frame: Twelve weeks

  4. Body mass index

    Time frame: Twelve weeks

    This outcome measure includes the measurements of body height and body weight.

  5. Functional capacity

    Time frame: Twelve weeks

    Peak oxygen consumption will be determined by graded exercise test to assess functional capacity.

  6. 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.

  7. Muscle oxygenation

    Time frame: Twelve weeks

    Muscle oxygenation will be assessed during exercise

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 11, 2012
Registry last updated
Nov 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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