Efficacy of Exercise at a Fitness Club for Cardiovascular Risk Reduction

NCT00106236 | Completed Phase 1

• 1 other identifier: SHPCR-2003-1
• Study Type: interventional
• Target: 561
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus; Hypertension; Hyperlipidemia

Keywords

Exercise; Fitness Club; Randomized Controlled Trial; Cardiovascular Risk Factor; Overweight; Inactivity

Outcome Measures

Primary Outcomes (3)

• Systolic blood pressure

• low-density lipoprotein cholesterol

• hemoglobin A1c

Secondary Outcomes (12)

• Body weight

• waist circumference

• diastolic blood pressure

• HDL-cholesterol

• triglyceride

Interventions

exercise BEHAVIORAL

Eligibility Criteria

• Age: 45 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sapporo Health Promotion Foundation: lead

Study Sites (1)

Sapporo Health Promotion Center

Sapporo, Hokkaido, 060-0063, Japan

Location

Related Publications (1)

• Igarashi K, Fujita K, Yamase T, Morita N, Okita K, Satake K, Kanazawa N, Nishijima H. Sapporo Fitness Club Trial (SFCT)--design, recruitment and implementation of a randomized controlled trial to test the efficacy of exercise at a fitness club for the reduction of cardiovascular risk factor--. Circ J. 2004 Dec;68(12):1199-204. doi: 10.1253/circj.68.1199.

  PMID: 15564707 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Hyperlipidemias; Motor Activity; Overweight; Sedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Behavior; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 21, 2005
• First Posted: March 22, 2005
• Study Start: April 1, 2003
• Study Completion: April 1, 2004
• Last Updated: July 14, 2009

Record last verified: 2005-03

Locations

JP (1)