Effect of 8 weeks High-Intensity Interval Training on Aerobic Capacity, Pulmonary Function, Quality of Life, and Right Ventricular Function in Patients with Acute Pulmonary Embolism: A Randomized Control Trial Study, a Pilot Study
The aim of the present study is to evaluate the effect of High-intensity interval training aerobic capacity, pulmonary function, right ventricular function, and quality of life in patients with acute pulmonary embolism.
Design
The patients with acute pulmonary embolism will be selected and based on computer randomization put in 2 groups: intervention and control. Intervention group will receive exercise training and control group received only usual care.
Settings and conduct
The present study is a non-blind study and will be conducted in Tehran Heart Center, Tehran, Iran. 2 to 4 weeks after discharge, the patients will be randomized into two groups and they will perform tests. After 8 weeks, the patients will repeat the test again.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Between 18-70 Years old; admitted with acute pulmonary embolism confirmed by pulmonary CT angiography; signed informed consent. Exclusion Criteria: History of recurrent pulmonary embolism; Low-risk pulmonary embolism; Have an elective procedure that would interrupt their exercise program; Unable to participate in an exercise program; Pregnancy; Unable to read and understand the consent form
Intervention groups
Intervention group: high-intensity interval training program
The control group: usual care without any rehabilitation intervention
Main outcome variables
Aerobic capacity, pulmonary function, quality of life, right ventricular function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170111031884N2
Registration date:2019-12-24, 1398/10/03
Registration timing:retrospective
Last update:2019-12-24, 1398/10/03
Update count:0
Registration date
2019-12-24, 1398/10/03
Registrant information
Name
Amine Ghram
Name of organization / entity
Faculty of Physical Education and Sport Science, Tehran University, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9600
Email address
amineghram.110@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2019-09-01, 1398/06/10
Expected recruitment end date
2019-09-30, 1398/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of 8 weeks High-Intensity Interval Training on Aerobic Capacity, Pulmonary Function, Quality of Life, and Right Ventricular Function in Patients with Acute Pulmonary Embolism: A Randomized Control Trial Study, a Pilot Study
Public title
High Intensity Interval Training in Acute Pulmonary Embolism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Between 18-70 Years old;
admitted with acute pulmonary embolism confirmed by pulmonary CT angiography
signed informed consent
Exclusion criteria:
History of recurrent pulmonary embolism
Low-risk pulmonary embolism
Unable to participate in an exercise program
Pregnancy
Unable to read and understand the consent form
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed using Block stratified Randomization software version 6.0 via permuted block stratified randomization method with random blocks of 4, 8, 2, 6, and 10 patients. Based on this random list, individuals will be dedicated to intermittent exercise or the control group (without exercise). In order to have a random allocation sequence concealment, the list will be given to a research assistant who is unaware of the study protocol and has not a role in the study. Due to the nature of the study, blinding will not be applicable for the patients, outcome assessor and the interventionists and only the statistician is blinded to the study.
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
Research Ethics Committee of Sport Sciences Research Institute
Assessed by recording the number and type of adverse events and any remedial action recorded in the patient’s exercise diary and interventionist records
Intervention groups
1
Description
The intervention group will receive a 8 weeks high intensity interval training, 3 sessions per week. Each session will last 50-55 minutes.
Category
Rehabilitation
2
Description
The control group will not receive any intervention.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran heart center
Full name of responsible person
Dr. Yaser Jenab
Street address
Tehran Heart Center, North Kargar Street, 14111713138
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Email
amineghram.110@ut.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research,Tehran Heart Center (TUMS)
Full name of responsible person
Dr. Saeed Sadeghian
Street address
Tehran Heart Center, North Kargar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Email
jenab@razi.tums.ac.ir
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 Heart Center (TUMS)
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 Heart Center
Full name of responsible person
Yaser Jenab
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Tehran Heart Center, North Kargar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
Email
jenab@razi.tums.ac.ir
Web page address
http://thc.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Yaser Jenab
Position
Associate Professor Of Cardiology
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Tehran Heart Center , North Kargar-Ave , Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9256
Fax
Email
jenab@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran Heart Center, North Kargar Ave, Tehran, Iran
Full name of responsible person
Yaser Jenab
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Tehran Heart Center, North Kargar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
Email
jenab@razi.tums.ac
Web page address
http://thc.tums.ac.ir
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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study protocol: The entire study protocol is shareable. Statistical Analysis Map: The entire statistical analysis map is shareable. clinical study report: The entire clinical study report is shareable. Data categorization system: The Data categorization system is shareable.
When the data will become available and for how long
Start the access period 2 months after printing results
To whom data/document is available
Researchers working in Academic Institutions
Under which criteria data/document could be used
For any kind of research in the field of medicine is possible.
From where data/document is obtainable
Amine Ghram 00989011631984 ghram.amine@hotmail.fr
What processes are involved for a request to access data/document
After sending the request by email within 2 weeks, the documentation is sent by email.