Changes in Adiponectin and Cardiovascular Disease Risk Factors in Overweight Patients

Exercise-based Cardiac Rehabilitation

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.

Study Overview

• Status: Completed
• Conditions: Exercise; Patients; Cardiac Myosins
• Intervention / Treatment: Other: Experimental; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; experimental group did 8 weeks exercise training	Other: 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
Experimental: Control; Control group did not do any exercise training.	Other: Control; They did not do ant exercise training during 8 weeks.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Effect of Exercise-based cardiac rehabilitation on weight was measured	up to 8 weks
Effect of Exercise-based cardiac rehabilitation on height was measured	up to 8 weks

Collaborators and Investigators

• Sponsor: University of Isfahan

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: August 12, 2016
• First Submitted That Met QC Criteria: August 29, 2016
• First Posted (Estimate): August 30, 2016

Study Record Updates

• Last Update Posted (Estimate): August 30, 2016
• Last Update Submitted That Met QC Criteria: August 29, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 201527898IR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No