Home Bicycle Exercise and Aerobic Capacity

October 15, 2014 updated by: TCVGH, Taichung Veterans General Hospital

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

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic syndrome
Time Frame: 12 weeks
Components of metabolic syndrome based on the modified Third Report of the National Cholesterol Education Program (NCEP) criteria
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks
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.)
12 weeks
Arterial stiffness
Time Frame: 12 weeks
Pulse wave velocity
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

September 27, 2014

First Submitted That Met QC Criteria

October 15, 2014

First Posted (Estimate)

October 20, 2014

Study Record Updates

Last Update Posted (Estimate)

October 20, 2014

Last Update Submitted That Met QC Criteria

October 15, 2014

Last Verified

October 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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