Home Bicycle Exercise and Aerobic Capacity

Sponsor

Taichung Veterans General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02268292

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Cardiovascular Syndrome	Behavioral: bicycle exercise	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Aug 1, 2014

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bicycle Exercise Bicycle Exercise for 12 weeks	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.

Arm

Intervention/Treatment

Experimental: Bicycle Exercise

Bicycle Exercise for 12 weeks

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.

Outcome Measures

Primary Outcome Measures

Metabolic syndrome [12 weeks]
Components of metabolic syndrome based on the modified Third Report of the National Cholesterol Education Program (NCEP) criteria

Secondary Outcome Measures

Muscle strength [12 weeks]
A Biodex Isokinetic Dynamometer (Biodex Medical Systems, Inc., Shirley, New York, USA) was used to evaluate the muscle strength of the subjects
Brain-derived neurotrophic factor [12 weeks]
Serum concentration of Brain-derived neurotrophic factor (enzyme immunoassay method, R&D Systems, Minneapolis, U.S.A.)
Arterial stiffness [12 weeks]
Pulse wave velocity

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Taichung Veterans General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

TCVGH, Taichung Veterans General Hospital, Taichung Veterans General Hospital

ClinicalTrials.gov Identifier:

NCT02268292

Other Study ID Numbers:

SG12147

First Posted:

Oct 20, 2014

Last Update Posted:

Oct 20, 2014

Last Verified:

Oct 1, 2014

Keywords provided by TCVGH, Taichung Veterans General Hospital, Taichung Veterans General Hospital

Brain-derived neurotrophic factor

Additional relevant MeSH terms:

Metabolic Syndrome

Study Results

No Results Posted as of Oct 20, 2014