The aim of the study is to compare the effect of cardiac rehabilitation plus medical treatment of patients suffering from coronary microvascular disease (X syndrome) with the same patients who are only under medical treatment. The study population are the patients with microvascular disease that have triad of angina pectoris, abnormal perfusion scan or exercise stress test and normal angiography (obstruction below 50%) with appropriate medical treatment. The subjects will be divided into two groups with randomized blocks. The intervention group will receive cardiac rehabilitation plus medical treatment and the control group will receive only medical treatment. There are 15 subjects in each group. Cardiac rehabilitation will be done for one month (3 sessions each week for total of 12 sessions). The main outcome is maximal aerobic capacity which is measured by cardio-pulmonary exercise test. Secondary outcomes are ventilatory threshold, Duck index, exercise duration, heart rate response and recovery. The researchers and the analysis committee will be blinded to the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015101024401N2
Registration date:2016-06-26, 1395/04/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-06-26, 1395/04/06
Registrant information
Name
Reza Mazaheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8833 6782
Email address
mazaheri_md@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences.
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Cardiac Rehabilitation with usual care on Cardio_pulmonary function of patients with X syndrome
Public title
Comparing the effect of Cardiac Rehabilitation with usual care on Cardio_pulmonary function of patients with X syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patients with angina pectoris; Abnormal perfusion scan; Normal angiogram with the coronary obstruction of below 50%; Receiving appropriate medical treatment. Typical or definite angina is sub-sternal chest discomfort that may radiate to the back, jaw, or arms, and/or symptoms which provoked by exertion or emotional stress and relieved by rest or nitroglycerin.
Exclusion criteria: Acute coronary syndromes; Uncontrolled hypertension (resting systolic blood pressure > 180 mm Hg and/or resting diastolic BP > 110); Significant aortic stenosis (aortic valve area < 1.0 cm2); Acute thrombophlebitis; Uncontrolled atrial or ventricular arrhythmias; Sinus tachycardia (>1 20 beats per minutes); Third-degree atrioventricular (AV) block without pacemaker; Acute pericarditis or myocarditis; Decompensated heart failure; Acute systemic illness or fever; Severe orthopedic conditions that would prohibit exercise; Other metabolic conditions such as acute thyroiditis, hypokalemia, hyperkalemia, or hypovolemia (until adequately treated).
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Tehran University of Medical Scinces
Street address
Keshavarz boulevard - Ghods street
City
Tehran
Postal code
Approval date
2015-11-22, 1394/09/01
Ethics committee reference number
IR.TUMS.REC.1394.1209
Health conditions studied
1
Description of health condition studied
Microvascular coronary syndrome
ICD-10 code
I20.9
ICD-10 code description
Anginal Syndrome
Primary outcomes
1
Description
Maximal aerobic capacity
Timepoint
One month
Method of measurement
cardio_pulmonary exercise test
2
Description
Duck Score
Timepoint
One month
Method of measurement
Exercise test
Secondary outcomes
1
Description
Ventilatory threshold
Timepoint
One month
Method of measurement
Cardio_pulmonary exercise test
2
Description
Duck questionaire
Timepoint
One month
Method of measurement
Cardio_pulmonary exercise test
3
Description
Recovery heart rate
Timepoint
One month
Method of measurement
Cardio_pulmonary exercise test
4
Description
Heart rate response
Timepoint
One month
Method of measurement
Cardio_pulmonary exercise test
5
Description
Exercise duration
Timepoint
One month
Method of measurement
Cardio_pulmonary exercise test
Intervention groups
1
Description
Control group: Routine medical treatment of cardiovascular risk factors including hyperlipidemia and hypertension.
Category
Treatment - Drugs
2
Description
Intervention: 12 sessions of cardiac rehabilitation including 3 sessions per week with intensity of 40-60% hear rate reserve or the BORG scale of 11-15 for each session up to 60 minutes and routine medical treatment of cardiovascular risk factors including hyperlipidemia and hypertension.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Sepideh Niyazi
Street address
End of Keshavarz boulevard-Imam khomeini hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Spideh Niyazi
Street address
End of Keshavarz Blv, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sepideh Niyazi
Position
Assistant of Sport Medicine
Other areas of specialty/work
Street address
Imam Khomeini hospital
City
Tehran
Postal code
1419733141
Phone
+98 21 6119 2282
Fax
Email
sepide.niyazi.sn @gmail
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Reza Mazaheri
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Khomeini hospital
City
Tehran
Postal code
1419733141
Phone
+98 21 6119 2282
Fax
Email
mazaheri_md@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)