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Completed

NCT Number: NCT02268292

Home Bicycle Exercise and Aerobic Capacity

The subjects with MetS or type 2 diabetes were enrolled for this exercise-training program. All participators underwent an indoor bicycle exercise for twelve weeks. In addition to demographic data and biochemical tests were determined after an overnight fasting. Extension of muscle strength was detected in the dominant lower extremity.

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Key information

Conditions

Metabolic Cardiovascular Syndrome Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

This prospective open-labeled study was conducted in Taichung Veterans General Hospital. The adult participants with metabolic syndrome and/or type 2 diabetes were enrolled. MetS. The procedures were fully explained to all subjects before the cardiopulmonary exercise test. ll enrolled subjects received a scheduled twelve-week program for exercise-training program. A commercially available bicycle with an indoor bicycle trainer are used as the home exercise training modality. All medications were not allowed to be changed during the study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult with metabolic syndrome or type 2 diabetes

Exclusion criteria

  • hyperglycemic crisis or HbA1c > 12%;
  • serum creatinine levels greater than 200 mmol/L;
  • acute or chronic infectious diseases;
  • limitations in the ability to undertake regular exercise

Treatment and study plan

bicycle exercise

Behavioral

All enrolled subjects received a scheduled twelve-week exercise program. A commercially available bicycle (Giant CS800, Taichung, Taiwan) with an indoor bicycle stand (Giant Cyclotron Mag, Taichung, Taiwan) was used as the home exercise training modality.

Primary outcomes

  1. Metabolic syndrome

    Time frame: 12 weeks

    Components of metabolic syndrome based on the modified Third Report of the National Cholesterol Education Program (NCEP) criteria

Secondary outcomes

  1. Muscle strength

    Time frame: 12 weeks

    A Biodex Isokinetic Dynamometer (Biodex Medical Systems, Inc., Shirley, New York, USA) was used to evaluate the muscle strength of the subjects

  2. Brain-derived neurotrophic factor

    Time frame: 12 weeks

    Serum concentration of Brain-derived neurotrophic factor (enzyme immunoassay method, R&D Systems, Minneapolis, U.S.A.)

  3. Arterial stiffness

    Time frame: 12 weeks

    Pulse wave velocity

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

The Effects of Home Bicycle Exercise Program on Hyperlipidemia, Hypertension, Blood Sugar Control, Muscle Strength and Aerobic Capacity

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 20, 2014
Registry last updated
Oct 20, 2014

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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