Changes in Adiponectin and Cardiovascular Disease Risk Factors in Overweight Patients

Sponsor

University of Isfahan (Other)

Overall Status

Completed

CT.gov ID

NCT02882672

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Exercise Cardiac Myosins Patients	Other: Experimental Other: Control	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Exercise-based Cardiac Rehabilitation

Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.
Effect of Exercise-based cardiac rehabilitation on lipids was measured by ELISA method [up to 8 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Isfahan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof.Mehdi Kargarfard, Professor Mehdi Kargarfard, University of Isfahan

ClinicalTrials.gov Identifier:

NCT02882672

Other Study ID Numbers:

201527898IR

First Posted:

Aug 30, 2016

Last Update Posted:

Aug 30, 2016

Last Verified:

Aug 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Study Results

No Results Posted as of Aug 30, 2016