Effect of High Intensity Interval Training (HIIT) with Blood Flow Restriction (BFR) on cardiovascular function of Cardiotoxic patients after Breast Cancer therapy(pilot study)
Determine the effect of High Intensity Interval Training with Blood Flow Restriction on cardiovascular function of Cardiotoxic patients after Breast Cancer therapy
Design
In this randomized, double blinded, sham controlled clinical trial with a parallel group design, 20 cardiotoxic patients who meet the study criteria will undergo an initial assessment.The eligible participants will be assigned randomly into following groups.1: progressive high intensity interval training(HIIT) between 60-70% and 80-90% of Maximum Heart Rate Reserve [Max HRR], 2: blood flow restriction(BFR) training in 100% optimal standard KAATSU unit [SKU] coupled with aerobic training at 60% to 70% of Max HRR, 3:HIIT combined with BFR with 60% of SKU, 4: Control active group (aerobic training at 60% to 70% of MAX HRR).all groups will undergo fully-supervised training 3 days/week for 12 weeks.Exercise training regimes will be performed in form of running on treadmill and after 12 weeks, post test will be done
Settings and conduct
Rajaie Cardiovascular Hospital
Participants/Inclusion and exclusion criteria
Inclusion:
Breast Cancer patients؛ Age less than 65 years؛In second phase of rehabilitation؛ Without Cardiac diseaes before Cancer treatment؛Treatment with Anthracycline drug؛ Ejection Fraction greater or equal 40 and less or equal 50؛ Permission of Cardiologist؛ Signature of consent letter
Exclusion:
Unable to do the exercises؛Symptoms of severe heart failure
Intervention groups
Doing:
1:High Intensity Interval Training
2:Aerobic training with Blood Flow Restriction(jogging on treadmill)
3:High Intensity Interval Training with Blood Flow Restriction
4:Active Control
Main outcome variables
It is expected that in all 4 groups, after rehabilitation treatment, will be have positive changes in cardiovascular system via echocardiography؛ also measured biomarkers and reduction in cardiac side effects of Chemotherapy drugs
General information
Reason for update
Acronym
BFR, HIIT
IRCT registration information
IRCT registration number:IRCT20200412047045N1
Registration date:2020-08-21, 1399/05/31
Registration timing:retrospective
Last update:2020-08-21, 1399/05/31
Update count:0
Registration date
2020-08-21, 1399/05/31
Registrant information
Name
Sara Adimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2225 4405
Email address
sa.adimi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-27, 1398/02/07
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
2019-04-27, 1398/02/07
Actual recruitment end date
2020-02-29, 1398/12/10
Trial completion date
2020-07-10, 1399/04/20
Scientific title
Effect of High Intensity Interval Training (HIIT) with Blood Flow Restriction (BFR) on cardiovascular function of Cardiotoxic patients after Breast Cancer therapy(pilot study)
Public title
Effect of High Intensity Interval Training with Blood Flow Restriction on cardiovascular function of Cardiotoxic patients after Breast Cancer therapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Breast Cancer patients
Age < 65y
Second phase of rehabilitation
Without Cardiac diseaes before Cancer Treatment
Treatment Drug: Anthracyclines
40 ≤Ejection Fraction≤ 50
Heart failure treatment: Beta blockers, ACEI
Permission of Cardiologist
Signature of consent letter
Exclusion criteria:
Conditions that cause the patient, not be able to perform the exercises(Fracture of limbs, pregnancy,…)
Symptoms of severe heart failure
Sign of recurrence of breast cancer (repeat chemotherapy)
Age
To 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced 8 block Randomization and Concealment by Packed in Pack
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study,Kaatsu cuff use for all four groups patients while training, but only in BFR and BFR+HIIT groups blood restricted with Kaatsu equipment will be applied and participants do not have information about the pressure difference applied by the equipment. also the evaluator of the outcome, the analyzer, the safety and monitoring committee, and the main researcher will be blind , and during this study, only Trainer is not .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rajaie Cardiovascular Medical and Research Center
Street address
Rajaie cardiovascular medical and research center, valiasr ave,Hashemi Rafsanjani highway
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2019-04-27, 1398/02/07
Ethics committee reference number
IR.RHC.REC.1398.010
Health conditions studied
1
Description of health condition studied
Cardiotoxicity
ICD-10 code
I42.7
ICD-10 code description
Cardiomyopathy due to drug and external agent
2
Description of health condition studied
Cardiac rehabilitation
ICD-10 code
Y71.1
ICD-10 code description
Therapeutic (nonsurgical) and rehabilitative cardiovascular devices associated with adverse incidents
3
Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
cardiovascular function
Timepoint
before intervention and after 12 weeks after intervention
Method of measurement
echocardiography
Secondary outcomes
1
Description
New York Heart Association (NYHA) Functional Classification
Timepoint
before and after 12 weeks intervention
Method of measurement
the New York Heart Association (NYHA) Functional Classification. It places patients in one of four categories based on how much they are limited during physical activity.
Intervention groups
1
Description
Intervention group: High Intensity Interval Training
Category
Rehabilitation
2
Description
Intervention group: Blood Flow Restriction
Category
Rehabilitation
3
Description
Intervention group: High Intensity Interval Training with Blood Flow Restriction
Category
Rehabilitation
4
Description
Control group: Active Control
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee cardiovascular, medical and research center
Full name of responsible person
Sara Adimi
Street address
Shahid Rajaee cardiovascular, medical and research center, Valiasr ave, Hashemi Rafsanjani highway
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2225 4405
Email
sara_adimi@yahoo.com
2
Recruitment center
Name of recruitment center
Shahid Rajaee cardiovascular, medical and research center
Full name of responsible person
Azin Alizadehasl
Street address
Shahid Rajaee cardiovascular, medical and research center, Valiasr ave, Hashemi Rafsanjani highway
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2190
Email
alizadeasl@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Ali Azarbayjani
Street address
Science and Research Branch,Shohada Hesarak blvd, Daneshgah Square,Sattari Highway, Tehran,I.R. IRAN
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 8880 3071
Email
ali.azarbaijani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Sara Adimi
Position
PhD student(exercise physiology)
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Shahid Rajaee cardiovascular, medical and research center, Valiasr ave, Hashemi Rafsanjani highway
City
Tehran
Province
Tehran
Postal code
199561433
Phone
+98 21 2225 4405
Email
sara_adimi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nasim Naderi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
ajaee cardiovascular, medical and research center, Valiasr ave, Hashemi Rafsanjani highway
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2115
Email
naderi.nasim@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sara Adimi
Position
PhD student(exercise physiology)
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Shahid Rajaee cardiovascular, medical and research center, Valiasr ave, Hashemi Rafsanjani highway
City
Tehran
Province
Tehran
Postal code
199561433
Phone
+98 21 2225 4405
Email
sara_adimi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
The primary and secondary out come measures can be shared after completion the trial and publishing the study results
When the data will become available and for how long
The data will be available after completion the trial and publishing the study results ( January 2021)
To whom data/document is available
for people working in academic institutions or people working in businesses can also apply to receive it.
Under which criteria data/document could be used
For performing the secondary studies such as systematic reviews
From where data/document is obtainable
the email address
What processes are involved for a request to access data/document
The request should be sent by email and the applicant will receive the data within a month