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Completed

NCT Number: NCT02882672

Changes in Adiponectin and Cardiovascular Disease Risk Factors in Overweight Patients

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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental

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

Other

They did not do ant exercise training during 8 weeks.

Primary outcomes

  1. Effect of Exercise-based cardiac rehabilitation on Serum levels of adiponectin was measured by ELISA method

    Time frame: up to 8 weeks

    Exercise sessions took place at 60-85% of maximal heart rate, lasted 45-60 minutes.

  2. Effect of Exercise-based cardiac rehabilitation on lipids was measured by ELISA method

    Time frame: up to 8 weeks

Secondary outcomes

  1. Effect of Exercise-based cardiac rehabilitation on weight was measured

    Time frame: up to 8 weks

  2. Effect of Exercise-based cardiac rehabilitation on height was measured

    Time frame: up to 8 weks

Sponsors and collaborators

Lead sponsor

University of Isfahan

Other

Registry information

Official study title

Exercise-based Cardiac Rehabilitation

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 30, 2016
Registry last updated
Aug 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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