Home Bicycle Exercise and Aerobic Capacity

Metabolic Cardiovascular Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02268292
• Other study ID #: SG12147
• Status: Completed
• Phase: Phase 4
• First received: September 27, 2014
• Last updated: October 15, 2014
• Start date: August 2012
• Est. completion date: August 2014

Study information

• Verified date: October 2014
• Source: Taichung Veterans General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolic Cardiovascular Syndrome
• Metabolic Syndrome X

Intervention

Behavioral:
• bicycle exercise
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic syndrome	Components of metabolic syndrome based on the modified Third Report of the National Cholesterol Education Program (NCEP) criteria	12 weeks	No
Secondary	Muscle strength	A Biodex Isokinetic Dynamometer (Biodex Medical Systems, Inc., Shirley, New York, USA) was used to evaluate the muscle strength of the subjects	12 weeks	No
Secondary	Brain-derived neurotrophic factor	Serum concentration of Brain-derived neurotrophic factor (enzyme immunoassay method, R&D Systems, Minneapolis, U.S.A.)	12 weeks	No
Secondary	Arterial stiffness	Pulse wave velocity	12 weeks	No