Changes in Adiponectin and Cardiovascular Disease Risk Factors in Overweight Patients

Exercise Clinical Trial

Official title:

Exercise-based Cardiac Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02882672
• Other study ID #: 201527898IR
• Status: Completed
• Phase: Phase 1
• First received: August 12, 2016
• Last updated: August 29, 2016
• Start date: January 2016
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: University of Isfahan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Myosins
• Exercise
• Patients

Intervention

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
• Control
They did not do ant exercise training during 8 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Isfahan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Effect of Exercise-based cardiac rehabilitation on lipids was measured by ELISA method		up to 8 weeks	No
Secondary	Effect of Exercise-based cardiac rehabilitation on weight was measured		up to 8 weks	No
Secondary	Effect of Exercise-based cardiac rehabilitation on height was measured		up to 8 weks	No