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Completed

NCT Number: NCT00106236

Efficacy of Exercise at a Fitness Club for Cardiovascular Risk Reduction

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Exercise

Behavioral

Primary outcomes

  1. Systolic blood pressure

  2. low-density lipoprotein cholesterol

  3. hemoglobin A1c

Secondary outcomes

  1. Body weight

  2. waist circumference

  3. diastolic blood pressure

  4. HDL-cholesterol

  5. triglyceride

  6. casual blood glucose

  7. high-sensitivity C-reactive protein

  8. white blood cell count

  9. estimated VO2max

  10. bicycle time

  11. leg muscle strength

  12. health-related QOL (Quality of Life)

Sponsors and collaborators

Lead sponsor

Sapporo Health Promotion Foundation

Other

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2004
First posted
Mar 22, 2005
Registry last updated
Jul 14, 2009

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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