Assessment of rehabilitation for recurrent syncope
Design
The study is a clinical trial with a control group, with parallel and randomized groups.
Settings and conduct
Patients referred to Tehran Heart Center Syncope Clinic are randomly divided into two groups for receiving 1) rehabilitation program 2) standard treatment. The intervention group is treated with the rehabilitation program and the control group receives standard treatment. Patients will be followed for syncope and presyncope symptoms, quality of life, anxiety and depression; at baseline, then at one month, three months, six months, and one year. The results are analyzed by SPSS software.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients presenting with syncope to Tehran Heart Center who have been diagnosed with a tilt test or clinical diagnosis of vasovagal syncope and have experienced at least two attacks during the year.
Exclusion criteria: Patients presenting with structural heart diseases, abnormal ECG, cardiac arrhythmias, neurological diseases, and patients who are receiving psychiatric treatment.
Pregnant or breastfeeding women
Intervention groups
Intervention group: The rehabilitation program which consists of three 4-hour sessions during the first month of the treatment:
- Practice with inclined boards
- Psychological counseling based on HADS criteria and referral to a psychiatrist if needed
-Counterpulsation maneuvers and aerobic exercise and home tilt training
Control group: standard treatment including education on the nature of the disease, home tilt training, and Counterpulsation maneuvers
Main outcome variables
recurrence of syncope, quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180125038507N2
Registration date:2020-01-15, 1398/10/25
Registration timing:retrospective
Last update:2020-01-15, 1398/10/25
Update count:0
Registration date
2020-01-15, 1398/10/25
Registrant information
Name
Masih Tajdini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9640
Email address
mtajdini@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Rehabilitation for reducing the symptoms and improving the quality of life in patients with recurrent vasovagal syncope: a randomized clinical trial
Public title
Rehabilitation for lessening the symptoms and improving the quality of life in patients with repeated vasovagal syncope
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All ptients with 2 or more vasovagal syncope episodes during the last year
Exclusion criteria:
Patients with structural heart diseases
Patients with abnormal ECG
Patients with neurologic diseases
Pregnant or breastfeeding women
Patients who receive psychiatric medications
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomized and divided into two groups of standard care (education-based), and standard care plus rehabilitation, based on permutation blocks. We will have four eight-spot blocks and three six-spot blocks. Each block contains equal spots for standard care and rehabilitation groups.
Blinding (investigator's opinion)
Not 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 of Tehran University of Medical Sciences
Street address
North Kargar Street, Tehran Heart Center, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713138
Approval date
2019-10-10, 1398/07/18
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.573
Health conditions studied
1
Description of health condition studied
Vasovagal Syncope
ICD-10 code
R55
ICD-10 code description
Syncope and collapse
Primary outcomes
1
Description
Prevalence of syncope and syncope symptoms
Timepoint
baseline, one month, three months, six months, 12 months
Method of measurement
Direct observation and measurement
2
Description
Quality of life
Timepoint
baseline, one month, three months, six months, 12 months
Method of measurement
SF36 Scale
3
Description
anxiety and depression
Timepoint
baseline, one month, three months, six months, 12 months
Method of measurement
HADS Sclae
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The one-month rehabilitation program consists of three sessions of a four-hour program: exercise with tilt table, Psychological counseling based on HADS score and referring to a psychiatrist if necessary, Doing counterpulsation maneuvers and aerobic sports, and home tilt training
Category
Behavior
2
Description
Control group: Receiving Standard treatment program including education about the disease and counterpulsation maneuvers and home tilt training
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Masih Tajdini
Street address
Tehran Heart Center, North Kargar Street
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Email
mtajdini@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masih Tajdini
Street address
Tehran Heart Center, North Kargar Street
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Email
mtajdini@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masih Tajdini
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Tehran Heart Center, North Kargar Street
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Email
mtajdini@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masih Tajdini
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Tehran Heart Center, North Kargar street
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9640
Fax
Email
mtajdini@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Faezeh Aghajani
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Tehran Heart Center, North Kargar street
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9640
Fax
Email
faezehaghajani.fa@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All the data about our participants
When the data will become available and for how long
After the study
To whom data/document is available
All of readers
Under which criteria data/document could be used
All the situations
From where data/document is obtainable
Corresponding author
What processes are involved for a request to access data/document