Efficacy of Exercise at a Fitness Club for Cardiovascular Risk Reduction

This study has been completed.
Sponsor:
Information provided by:
Sapporo Health Promotion Foundation
ClinicalTrials.gov Identifier:
NCT00106236
First received: March 21, 2005
Last updated: July 13, 2009
Last verified: March 2005
  Purpose

The purpose of the study is to determine whether exercise has further beneficial effects on improving cardiovascular risk factors such as hypertension, high cholesterol level or diabetes mellitus, when added to the standard program of health check followed by life style recommendations.


Condition Intervention Phase
Diabetes Mellitus
Hypertension
Hyperlipidemia
Behavioral: exercise
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Sapporo Fitness Club Trial (SFCT): A Randomized Controlled Trial to Test the Efficacy of Exercise at a Fitness Club for the Reduction of Cardiovascular Risk Factors

Resource links provided by NLM:


Further study details as provided by Sapporo Health Promotion Foundation:

Primary Outcome Measures:
  • Systolic blood pressure
  • low-density lipoprotein cholesterol
  • hemoglobin A1c

Secondary Outcome Measures:
  • Body weight
  • waist circumference
  • diastolic blood pressure
  • HDL-cholesterol
  • triglyceride
  • casual blood glucose
  • high-sensitivity C-reactive protein
  • white blood cell count
  • estimated VO2max
  • bicycle time
  • leg muscle strength
  • health-related QOL (Quality of Life)

Estimated Enrollment: 561
Study Start Date: April 2003
Estimated Study Completion Date: April 2004
Detailed Description:

Multiple risk factors contribute to the causation of atherosclerotic cardiovascular disease. Past studies indicate that exercise exerts its protective effects on the disease through actions on multiple cardiovascular risk factors simultaneously; however, the studies focused on the effect of exercise predominantly on subjects with a single risk factor. Does exercise differentially act on various risk factors in the same subject? Do subjects with multiple risk factors respond differently to exercise than those predominantly with a single risk factor do? To our knowledge, this is the first large-scale study to test the efficacy of exercise on subjects with multiple risk factors. Exercise in fitness clubs has uniquely fitting features for middle to older aged people with multiple risk factors: access is relatively easy because there are usually many clubs throughout the city; the control of exercise intensity or heart rate is made precise, rendering exercise safer when treadmills or bicycles are used as a mainstay of aerobic exercise as in this study; and cardiac arrest, the most feared complication of exercise, will be most likely to be properly handled since in recent years the installment of automated external defibrillators has been increasingly popular in many clubs.

Comparison: Exercise vs. standard care comparison is to be made only for the first 6-month period. The second 6-month period is for follow-up and other purposes.

  Eligibility

Ages Eligible for Study:   45 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Body mass index (BMI) of 24.2-34.9 with 2 or more of the following risk factors:

  • Resting systolic blood pressure of 130-179 mmHg
  • Fasting blood glucose of 110-139 mg/dl, or HbA1c ≥ 5.8 when casual blood sugar is 140-199 mg/dl
  • LDL-cholesterol of 120-219 mg/dl

Exclusion Criteria:

  • Diastolic blood pressure of 110 mmHg or greater
  • History of clinical heart disease or stroke
  • Orthopedic problems that might interfere with exercise
  • Dementia
  • Abnormal exercise EKG test results
  • Private physician's disapproval
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00106236

Locations
Japan
Sapporo Health Promotion Center
Sapporo, Hokkaido, Japan, 060-0063
Sponsors and Collaborators
Sapporo Health Promotion Foundation
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00106236     History of Changes
Other Study ID Numbers: SHPCR-2003-1
Study First Received: March 21, 2005
Last Updated: July 13, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sapporo Health Promotion Foundation:
Exercise
Fitness Club
Randomized Controlled Trial
Cardiovascular Risk Factor
Overweight
Inactivity

Additional relevant MeSH terms:
Hypertension
Diabetes Mellitus
Hyperlipidemias
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on October 01, 2014