Clinical trial NCT02882672: Changes in Adiponectin and Cardiovascular Disease Risk Factors in Overweight Patients
Official title: Exercise-based Cardiac Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Exercise
Cardiac Myosins
Patients
Lead sponsor: University of Isfahan
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Effect of Exercise-based cardiac rehabilitation on Serum levels of adiponectin was measured by ELISA method
timeFrame: up to 8 weeks
measure: Effect of Exercise-based cardiac rehabilitation on lipids was measured by ELISA method
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Effect of Exercise-based cardiac rehabilitation on weight was measured
timeFrame: up to 8 weks
measure: Effect of Exercise-based cardiac rehabilitation on height was measured
timeFrame: up to 8 weks
Other outcomes:
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