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The effects of photobiomodulation therapy(low level LASER therapy) on functional capacity and quality of life of patients with heart failure reduced ejection fraction who are on cardiac rehabilitation programs : (double blind randomized )

Protocol summary

Study aim
The primary objective of the present study is to show the beneficial effect of photobiomodulation therapy(PBMt) on heart failure patients
Design
A concealed, randomized, blinded, placebo controlled clinical trial with a parallel group design of 30 heart failure patients with blinded outcome assessment .(Phase 3)
Settings and conduct
We will enroll patients who have diagnosed as heart failure reduced ejection fraction for cardiac rehabilitation program. The study will be conducted in cardiac rehb department of Rajaie cardiovascular medical and research center and low level LASER probe will be placed on the forearm skin at the 6 acupuncture points(PC6, PC7,HR4,HR5,HR6,ULNAR ARTERY ACUPOINT). In the placebo group the LASER system will remain off -state . Both patient and outcomes evaluator will be blinded
Participants/Inclusion and exclusion criteria
Participants: patients who have diagnosed as heart failure (a left ventricular ejection fraction equal or less than 40 %) who have been referred for cardiac rehabilitation program
Intervention groups
The patients were randomized into two groups: (1)active Low level LASER therapy group (n=15)—subjects who will be submitted to active laser therapy and (2) placebo low level LASER therapy group (n=15)—subjects who will be submitted to placebo laser after 20 minutes LASER/placebo therapy ,the patients will go for aerobic sub maximal exercise using ergo meter bike for 20 minutes (5 minutes warm up ,two 10 minutes sessions with 5 minutes rest between them ,5 minutes cool down)
Main outcome variables
New-York heart association functional class,6 minutes' walk test distance,serum NT-pro BNP level,quality of life score,Echocardiographic variables(LVEF,left ventricular end systolic and diastolic dimentions,LV global longitudinal strain)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191207045638N1
Registration date: 2019-12-10, 1398/09/19
Registration timing: registered_while_recruiting

Last update: 2019-12-10, 1398/09/19
Update count: 0
Registration date
2019-12-10, 1398/09/19
Registrant information
Name
Nasim Naderi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2115
Email address
naderi.nasim@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-04-19, 1399/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of photobiomodulation therapy(low level LASER therapy) on functional capacity and quality of life of patients with heart failure reduced ejection fraction who are on cardiac rehabilitation programs : (double blind randomized )
Public title
photobiomodulation therapy(low level LASER therapy) in heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Expressed readiness to comply with all study procedures and availability for the duration of the study Provision of dated and signed informed consent form Age 18-65 years A diagnosis of heart failure reduced ejection fraction (LVEF≤ 40%) due to ischemic or non-ischemic etiology Optimal guideline directed medical therapies including angiotensin-converting enzymeinhibitors, β-blockers, aldosterone antagonists, and diuretics for at least 3 months NewYork Heart association function class (NYHA Class) II-III
Exclusion criteria:
History of hospitalization for any cause including acute heart failure in preceding month presence Chronic renal failure or dialysis presence of chronic hepatic failure presence of neuromuscular disorders Presence of severe chronic pulmonary disease The patients who have pace maker, intracardiac defibrillator (ICD)or cardiac resynchronization therapy(CRT) psychiatric conditions inability to perform 6 minutes walk test Cardiomyopathy secondary to cancer therapy Presence of any hematologic , Rheumatologic disorder
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization will be performed through block randomization, and allocation secrecy will be kept by numbered, opaque, sealed envelopes
Blinding (investigator's opinion)
Double blinded
Blinding description
The code from the drawing of the study will be given to a care provider that set the unit to either active low level LASER therapy or placebo LASER mode; thus, the study will be conducted in a double blinded placebo-controlled manner, both to the participants and to the investigator,out come assessor and data analyser
Placebo
Not used
Assignment
Parallel
Other design features
The sample volume was calculated after a pilot trial on 5 heart failure patients .The aim in the pilot study was 6 minutes walk test distance which was increased from a mean of 300±48 meter to 470±60 meter after low level LASER therapy .The calculated sample volume considering two mean±SD,alpha=1% power 97% ,was about 12 patients and 15 patient was chosen for each group

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethic committee of science and research branch of Islamic Azad university, Tehran/Iran
Street address
Science and Research Branch,shodada Hesarak blvd, Daneshgah Square,Sattari Highway,Tehran, I.R. IRAN
City
Tehran
Province
Tehran
Postal code
1477893855
Approval date
2018-07-08, 1397/04/17
Ethics committee reference number
IR.IAU.SRB.REC.1397.041

Health conditions studied

1

Description of health condition studied
Heart failure reduced ejection fraction
ICD-10 code
I50
ICD-10 code description
Heart failure

Primary outcomes

1

Description
NewYork Heart Association functional class, Physical performance( 6 minutes walk test distance)
Timepoint
Before intervention and after completion of intervention
Method of measurement
1-New York heart association(NYHA) measurement :NYHA scores range from I (no symptoms of heart failure ) to IV (symptoms at rest) 2- Physical performance of patients was assessed using the 6‐minute walk test (6MWT) according to the protocol of Guyatt and colleagues

Secondary outcomes

1

Description
serum level of N terminal pro -brain natreuretic peptide
Timepoint
before intervention and at the intervention completion
Method of measurement
enzyme immunoassay

2

Description
Quality of life
Timepoint
before intervention and at the intervention completion
Method of measurement
Iranian quality of life questionnaire (IHF-QOL)

3

Description
Echocardiographic data: left ventricular ejection fraction ,Left ventircular end diastolic and systolic dimentions,left ventricular global longitudinal strain
Timepoint
before intervention and at the intervention completion
Method of measurement
Echocardiographic machine

Intervention groups

1

Description
Intervention group: َActive LASER group(n=15)The intervention group will received low level LASER therapy ( LASER device: GALALAS,650nm,5Mw) before sub maximal aerobic exercise(cycle) , laser therapy is applied (150 J/cm2 per point) at 6 points on forearm at acupuncture points( PC6-PC7-HR4-HR5-HR6,ulnar artery acupuncture point) for 20 minutes
Category
Treatment - Other

2

Description
Control group: ) placebo low level LASER therapy group (n=15)—subjects who will be submitted to placebo laser after 20 minutes LASER/placebo therapy .In the placebo group the LASER system will remain off -state
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Rajaie cardiovascular medical and research center
Full name of responsible person
Nasim Naderi
Street address
Rajaie 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

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hassan Matin Homaei
Street address
Science and Research Branch,shodada Hesarak blvd, Daneshgah Square,Sattari Highway,Tehran, I.R. IRAN
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5154
Email
has.matinhomaei@iauctb.ac.ir
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Homa Bahrami
Position
Post Doc student (exercise physiology)
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Science and Research Branch,shodada Hesarak blvd, Daneshgah Square,Sattari Highway,Tehran, I.R. IRAN;
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 8249 9612
Email
bahramihoma4@gmail.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
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Rajaie cardiovascular medical and research center,Valiasr ave,Hashemi Rafsanjani highway
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2392 2115
Fax
Email
naderi.nasim@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nasim Naderi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Rajaie 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

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
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