Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
General information
2023-10-12, 1402/07/20
2024-04-08, 1403/01/20
20232024-1004-1208 00:00:00
2024-05-04, 1403/02/15
2024-06-09, 1403/03/20
2024-0506-0409 00:00:00
2023-12-06, 1402/09/15
2024-04-15, 1403/01/27
20232024-1204-0615 00:00:00
2024-05-19, 1403/02/30
2024-06-14, 1403/03/25
2024-0506-1914 00:00:00
2024-05-30, 1403/03/10
2024-06-14, 1403/03/25
2024-0506-3014 00:00:00
Protocol summary
Study aim
Determining the effect of breathing exercises on the severity of fatigue, dyspnea, and functional classification of heart failure patients
Design
Three-arm parallel groups randomized trial without blinding on 100 patients. The sealed envelope method will be used for simple random division
Settings and conduct
The study is conducted at Shahid Modarres Hospital of Tehran affiliated with Shahid Beheshti University of Medical Sciences. The patients will be selected by convenience sampling and placed in three groups in a simple random method. Breathing exercises in two different ways (incentive spirometry; diaphragmatic and pursed-lip breathing exercises) will be performed three times a day for 10 days in the patients of the two intervention groups. In the control group, usual treatments and care are performed. Before the start of the intervention and after its completion, variables of fatigue, dyspnea, and functional classification are measured in all patients.
Participants/Inclusion and exclusion criteria
Heart failure patients of both sexes at least 20 years old; ability to read and write; EF lower than 55%; NYHA functional classification between classes II to IV; No history of psychological disorders, cancer, anemia, renal failure, diabetes, and neurological disorders
Intervention groups
A control group; a group of diaphragmatic and pursed lip breathing exercises; a group of flow oriented incentive spirometry
According to the end of the intervention, the start and end dates of sampling were updated.
Acronym
IRCT registration information
IRCT registration number:IRCT20240306061197N1
Registration date:2024-04-14, 1403/01/26
Registration timing:prospective
Last update:2024-07-17, 1403/04/27
Update count:2
Registration date
2024-04-14, 1403/01/26
Registrant information
Name
Amirhossein Nasirmoghadas
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8803 8972
Email address
amir.h.nasirmoghadas@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-08, 1403/01/20
Expected recruitment end date
2024-06-09, 1403/03/20
Actual recruitment start date
2024-04-15, 1403/01/27
Actual recruitment end date
2024-06-14, 1403/03/25
Trial completion date
2024-06-14, 1403/03/25
Scientific title
The Effect of Breathing Exercises on Fatigue Severity, Dyspnea, and Functional Classification in Patients with Heart Failure
Public title
The Effect of Breathing Exercises on Fatigue Severity, Dyspnea, and Functional Classification in Patients with Heart Failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Heart failure patients with Ejection Fraction (EF) lower than 55%
NYHA functional classification between classes II to IV
Ability to read and write
Informed consent
Exclusion criteria:
No history of psychological disorders, cancer, anemia, renal failure, diabetes, and neurological disorders
Simultaneous participation in any study that includes breathing exercises or any intervention effective on fatigue and dyspnea
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The sealed envelope method will be used for simple random division. Each participant will draw a sealed envelope containing a number between 1 and 3. Patients who draw number 1 will be placed in the control group, number 2 in the diaphragmatic and pursed-lip breathing exercises group (DG), and number 3 in flow-oriented incentive spirometry.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The study will have three groups, including a control group, a group of diaphragmatic and pursed-lip breathing exercises, and an incentive spirometry group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University
Street address
Nursing and Midwifery Faculty, Intersection of Valiasr St. and Niayesh Highway
City
Tehran
Province
Tehran
Postal code
1996835119
Approval date
2022-10-25, 1401/08/03
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.161
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Fatigue severity score based on FSS questionnaire
Timepoint
Before and after the intervention
Method of measurement
Fatigue Severity Scale (FSS) questionnaire
2
Description
Dyspnea severity based on modified Borg dyspnea scale
Timepoint
Before and after the intervention at rest and on exertion
Method of measurement
score of modified Borg dyspnea scale
3
Description
New York Heart Association (NYHA) Functional Classification
Timepoint
Before and after the intervention
Method of measurement
New York Heart Association (NYHA) Functional Classification based on severity of symptoms especially fatigue and dyspnea
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: diaphragmatic and pursed-lip breathing exercises, thrice a day for 10 days and each time for 10 minutes. take a 2-minute rest for every 1 minute of performing the breathing exercises (10 breaths/minute)
Category
Rehabilitation
2
Description
Intervention group 2: use of flow-oriented spirometry three times a day for 10 days. Each time, two rounds of 10 breaths and a few minutes of rest between each round
Category
Rehabilitation
3
Description
Control group: Continue the usual treatments and care