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CompletedNCT02882672Updated Aug 30, 2016

Changes in Adiponectin and Cardiovascular Disease Risk Factors in Overweight Patients

A Phase 1 interventional study of Experimental and Control in Exercise, Cardiac Myosins and Patients, sponsored by University of Isfahan. Completed. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-30.

Sponsored by University of Isfahan · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Exercise
  • Cardiac Myosins
  • Patients
03

In context

Lead sponsor

University of Isfahan is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Experimental

    experimental group did 8 weeks exercise training

    Other: Experimental

  • Experimental
    Control

    Control group did not do any exercise training.

    Other: Control

Interventions

  • OtherExperimental

    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

  • OtherControl

    They did not do ant exercise training during 8 weeks.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 8 weeks

  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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02882672
Lead sponsor
University of Isfahan
Responsible party
Prof.Mehdi Kargarfard (Professor Mehdi Kargarfard, University of Isfahan) — Principal investigator
First posted
Aug 30, 2016
Start date
Jan 2016
Primary completion
Mar 2016
Completion
Jun 2016
Last update
Aug 30, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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