Changes in Adiponectin and Cardiovascular Disease Risk Factors in Overweight Patients

Phase 1

Completed

• Conditions: Patients; Exercise; Cardiac Myosins
• Interventions: Other: Control; Other: Experimental

• Registration Number: NCT02882672
• Lead Sponsor: University of Isfahan

Brief Summary

This study aimed to determine if eight-weeks of exercise-based cardiac rehabilitation could improve adiponectin and cardiovascular disease risk factors in overweight coronary heart disease patients. Patients were included in the study if: they were approved to do so following a physical, physiological and psychological test; did not take part in regular physical activity; had stable heart failure for at least 3 months. Exclusion criteria included: a history of surgery within the preceding 4 months; had an unstable angina, acute phase of myocardial infarction, and/or unstable arrhythmia; had obstructive cardiomyopathy, exercise-induced ischemia or arrhythmias, uncontrolled arrhythmias, resting blood pressure more than 200/120 millimeters mercury, aortic stenosis, and/or peripheral artery disease; exercise limitations due to neuromuscular and/or musculoskeletal disease; had any health problems that prevented maximum effort on the treadmill test. Target population included of all patients with a history of myocardial infarction and diagnosis of congestive heart failure who were referred to Isfahan Cardiovascular Research Centre. 60overweight coronary heart disease patients were randomly assigned to either an eight-week, three times weekly exercise group (n=30), or a non-exercising control group (n=30). Exercise sessions took place at 60-85% of maximal heart rate, lasted 45-60 minutes and included a 10-minute warm-up, 40 minutes of aerobic exercises, consisting of stationary cycling, walking and/or jogging, flexibility, balance exercises, and weight-bearing activity and a 10-minute cool-down.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2016-03
• Study Completion: 2016-06
• Status Verified: 2016-08
• Study First Submitted: 2016-08-12
• Study First Submitted QC: 2016-08-29
• Last Update Submitted: 2016-08-29
• Study First Posted: 2016-08-30
• Last Update Posted: 2016-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• they were approved to do so following a physical, physiological and psychological test; resided and worked in the city of Isfahan; did not take part in regular physical activity; had stable heart failure for at least 3 months.

Exclusion Criteria

• a history of surgery within the preceding 4 months
• had an unstable angina, acute phase of myocardial infarction (MI), and/or unstable arrhythmia
• had obstructive cardiomyopathy, exercise-induced ischemia or arrhythmias, uncontrolled arrhythmias, resting blood pressure more than 200/120 millimeters mercury (mmHg), aortic stenosis, and/or peripheral artery disease
• exercise limitations due to neuromuscular and/or musculoskeletal disease, such as any type of orthopedic, low back pain, bone fracture of less than 6 months
• uncontrolled systemic disease, such as DM; were 75 years or older
• had any health problems that prevented maximum effort on the treadmill test
• unable to answer the screening questionnaires assessing depression and anxiety.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control	Control	Control group did not do any exercise training.
Experimental	Experimental	experimental group did 8 weeks exercise training

Primary Outcome Measures

Name	Time	Method
Effect of Exercise-based cardiac rehabilitation on lipids was measured by ELISA method	up to 8 weeks
Effect of Exercise-based cardiac rehabilitation on Serum levels of adiponectin was measured by ELISA method	up to 8 weeks	Exercise sessions took place at 60-85% of maximal heart rate, lasted 45-60 minutes.

Secondary Outcome Measures

Name	Time	Method
Effect of Exercise-based cardiac rehabilitation on height was measured	up to 8 weks
Effect of Exercise-based cardiac rehabilitation on weight was measured	up to 8 weks