Objective: To determine the effect of inspiratory muscle training on the severity of dyspnea and fatigue in patients with chronic heart failure will Methods: This study is a clinical trial. Inclusion criteria included LVEF less than 40% on echocardiography, based on standard New York Heart Association Class 2 and 3 patients out of acute myocardial infarction and acute illness is .myarhay is infectious. A total of 100 patients randomly into two groups of intervention and control are blocked. Inspiratory muscle training for 6 weeks for patients in the intervention group performed. Before and after the intervention, the shortness of breath and fatigue using the Fatigue Severity Scale Fatigue Severity Scale (FSS) and Scale adjusted shortness of breath, Medical Research Council Modified Medical Research Council dyspnea scale (MRC) will be assessed. The control group received usual care, and at the beginning and end of six weeks, completed questionnaires and fatigue and shortness of breath is measured
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071324080N2
Registration date:2016-11-27, 1395/09/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-27, 1395/09/07
Registrant information
Name
Mohammad Gholami
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 509 1279
Email address
gholami.m@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
: Effects of inspiratory muscle training on fatigue and dyspnea in patients with chronic heart failure
Public title
: Effects of inspiratory muscle training on fatigue and dyspnea in patients with chronic heart failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 18-65 years; being clinically stable; left ventricular ejection fraction (LVEF) below 40%; New York Heart Association (NYHA) Class II and III; no change in medications over three months; Patients with cardiac pacemaker were included after 6 weeks after implementation.
Exclusion criteria: having acute myocardial infarction; cognitive disorders; complex arrhythmias; uncontrolled hypertension; angina pectoris; recent viral infections (6 months prior to study); orthopedic problems; and rheumatologic diseases.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Lorestan University of Medical Sciences
Street address
Campus of Kamalvand Pardis, Lorestan University of Medical Sciences
City
Khorramabad
Postal code
6814993165
Approval date
2016-07-11, 1395/04/21
Ethics committee reference number
Lums.REC.1395.106
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
I50.9
ICD-10 code description
Heart failure, unspecified
Primary outcomes
1
Description
fatigue
Timepoint
immediately before intervention and 6 weeks after intervention
Method of measurement
fatigue severity scale (FSS)
Secondary outcomes
1
Description
Dyspnea
Timepoint
immediately before intervention and 6 weeks after intervention
Method of measurement
Modified Medical Research Council dyspnea scale(MRC)
Intervention groups
1
Description
Treatment group: Treatment group will perform Inspiratory Muscle Training (IMT) for 30min, 7 days per week, for 6weeks using the Threshold device (Respironics).each seven session will perform at home. Treatment group will receive IMT at 40% of Maximal inspiratory pressure (MIP), and training loads will adjust to maintain 40% of the MIP, weekly.
Category
Rehabilitation
2
Description
control group: control group will receive usual care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
Amir Hossein Hossein Pour
Street address
Campus of Kamalvand Pardis
City
Khorramabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Amir Hossein Hossein Pour
Street address
Campus of Kamalvand Pardis, Lorestan University of Medical Sciences
City
khorramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Amir Hossein Hossein Pour
Position
Undergraduate Nursing Student
Other areas of specialty/work
Street address
Campus of Kamalvand Pardis, Lorestan University of Medical Sciences
City
Khorramabad
Postal code
6814993165
Phone
+98 66 3312 0140
Fax
Email
amir.ho3ein19955313@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Mohammad Gholami
Position
PHD of Nursing
Other areas of specialty/work
Street address
Campus of Kamalvand Pardis, Lorestan University of Medical Sciences
City
Khorramabad
Postal code
6814993165
Phone
+98 66 3312 0140
Fax
Email
mohammad13565@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Amir Hossein Hossein Pour
Position
Undergraduate Nursing Student
Other areas of specialty/work
Street address
Campus of Kamalvand Pardis, lorestan university of medical sciences
City
Khorramabad
Postal code
6814993165
Phone
+98 66 3312 0140
Fax
Email
amir.ho3ein19955313@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)