Protocol summary
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Study aim
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Determining the effect of breathing exercises on the severity of fatigue, dyspnea, and functional classification of heart failure patients
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Design
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Three-arm parallel groups randomized trial without blinding on 100 patients. The sealed envelope method will be used for simple random division
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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A control group; a group of diaphragmatic and pursed lip breathing exercises; a group of flow oriented incentive spirometry
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Main outcome variables
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Fatigue severity; dyspnea; functional classification
General information
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Reason for update
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According to the end of the intervention, the start and end dates of sampling were updated.
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Acronym
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IRCT registration information
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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
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Registration date
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2024-04-14, 1403/01/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-04-08, 1403/01/20
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Expected recruitment end date
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2024-06-09, 1403/03/20
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Actual recruitment start date
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2024-04-15, 1403/01/27
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Actual recruitment end date
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2024-06-14, 1403/03/25
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Trial completion date
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2024-06-14, 1403/03/25
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Scientific title
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The Effect of Breathing Exercises on Fatigue Severity, Dyspnea, and Functional Classification in Patients with Heart Failure
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Public title
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The Effect of Breathing Exercises on Fatigue Severity, Dyspnea, and Functional Classification in Patients with Heart Failure
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
100
Actual sample size reached:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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The study will have three groups, including a control group, a group of diaphragmatic and pursed-lip breathing exercises, and an incentive spirometry group.
Ethics committees
1
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Ethics committee
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Approval date
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2022-10-25, 1401/08/03
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Ethics committee reference number
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IR.SBMU.PHARMACY.REC.1401.161
Health conditions studied
1
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Description of health condition studied
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Heart failure
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ICD-10 code
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I50
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ICD-10 code description
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Heart failure
Primary outcomes
1
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Description
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Fatigue severity score based on FSS questionnaire
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Timepoint
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Before and after the intervention
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Method of measurement
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Fatigue Severity Scale (FSS) questionnaire
2
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Description
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Dyspnea severity based on modified Borg dyspnea scale
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Timepoint
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Before and after the intervention at rest and on exertion
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Method of measurement
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score of modified Borg dyspnea scale
3
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Description
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New York Heart Association (NYHA) Functional Classification
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Timepoint
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Before and after the intervention
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Method of measurement
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New York Heart Association (NYHA) Functional Classification based on severity of symptoms especially fatigue and dyspnea
Intervention groups
1
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Description
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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)
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Category
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Rehabilitation
2
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Description
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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
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Category
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Rehabilitation
3
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Description
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Control group: Continue the usual treatments and care
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available