Changes in Adiponectin and Cardiovascular Disease Risk Factors in Overweight Patients

NCT ID: NCT02882672

Last Updated: 2016-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-06-30

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.

Conditions

Exercise; Cardiac Myosins; Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

experimental group did 8 weeks exercise training

Group Type: EXPERIMENTAL

Experimental

Intervention Type: OTHER

Doing exercise 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

Control

Control group did not do any exercise training.

Group Type: EXPERIMENTAL

Control

Intervention Type: OTHER

They did not do ant exercise training during 8 weeks.

Interventions

Experimental

Doing exercise 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

Intervention Type: OTHER

Control

They did not do ant exercise training during 8 weeks.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Isfahan

OTHER

Sponsor Role: lead

Responsible Party

Prof.Mehdi Kargarfard

Professor Mehdi Kargarfard

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

201527898IR

Identifier Type: -

Identifier Source: org_study_id