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Effect of incentive spirometry to ventilation of hemodialysis patients

Protocol summary

Summary
Hemodialysis patients experience a variety of complications one of the complications is respiratory system disorder.The incentive spirometer can help hemodialysis patients to improve their respiratory status. the main goal of this research is determine the effect of Incentive spirometry on pulmonary ventilation of hemodialysis patients. and sub goals is : 1.Determine and compare the FVC, FEV1, FEV1/FVC before the study, in the intervention and control groups. 2. Determine and compare the FVC, FEV1, FEV1/FVC month after the intervention, in the intervention and control groups. 3. Determine and compare the FVC, FEV1, FEV1/FVC, two months after the intervention,in the intervention and control groups. 4. Comparison of FVC, FEV1, FEV1/FVC before the study, one month and two months after in the intervention group 5. Comparison of FVC, FEV1, FEV1/FVC before the study, one month and two months after the intervention in the control group 6. Determine and compare the average distance over 6 minutes walk before, one month and two months after in the intervention and control groups Participants must be at least 6 months of hemodialysis treatment. Inclusion criteria: completely satisfactory cooperation; ability to perform spirometry; normal chest and spine according to the patient stated; minimum age 18 years; hemodialysis three times a week; hemodialysis for at least 6 months; no history of chronic lung disease; absence of valvular heart disease; CHF; cardiac arrhythmia; high blood pressure of 100/180 and lower than 60/100. Exclusion criteria: severe disability; the patient's unwillingness to cooperate; cardiac surgery or chest area Lung volumes and the distance in 6 minutes walking measured initially in the participants, and then use of incentive spirometry applies for two months as intervention. One and two months after the intervention indicators are measured and compared with before the intervention. Expected to improve lung volumes.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201208052226N10
Registration date: 2012-10-15, 1391/07/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-10-15, 1391/07/24
Registrant information
Name
Mansooreh Aliasgharpour
Name of organization / entity
Nursing & midwifery faculty, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 7120
Email address
aliasgha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2012-10-21, 1391/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of incentive spirometry to ventilation of hemodialysis patients
Public title
Effect of incentive spirometry to ventilation of hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: completely satisfactory cooperation; ability to perform spirometry; normal chest and spine according to the patient stated; minimum age 18 years; hemodialysis three times a week; hemodialysis for at least 6 months; no history of chronic lung disease; absence of valvular heart disease; CHF; cardiac arrhythmia; high blood pressure of 100/180 and lower than 60/100. Exclusion criteria: severe disability; the patient's unwillingness to cooperate; cardiac surgery or chest area during the study; patient die during the study and acute complications of pulmonary infection during the study.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Science
Street address
Faculty of Nursing and Midwifery, Eastern-Nosrat Stereet, Tohid Sq., Tehran, Iran.
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
91/d/130/575

Health conditions studied

1

Description of health condition studied
Hemodialysis patient
ICD-10 code
Z49.1
ICD-10 code description
Extracorporeal dialysis

Primary outcomes

1

Description
Ventilation of hemodialysis patients
Timepoint
Before the intervention, after a month and two months after
Method of measurement
Spirometer

Secondary outcomes

1

Description
The distance traveled in 6 minutes by the patient
Timepoint
Ago, one month and two months after intervention
Method of measurement
6 minutes walk test

Intervention groups

1

Description
In the intervention group, patients during two months, every day to 3-5 times, each time three times in 5 minutes on the training of researchers will use the incentive spirometer.the patient is taught that mouthpiece of the device to put in your mouth, perform inhalation with maximum, imprisonment breath to for 3 seconds, then exhalation with pressure.عsing Spirometry guide as a pamphlet give to experimental group participants.
Category
Rehabilitation

2

Description
Control group receive routine hospital
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Hasheminezhad hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical science, research dputy
Full name of responsible person
Dr. Akbar Fotohi
Street address
tehran, keshavarz blvd., ghods st., ghods bld.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical science, research dputy
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
Tehran University of Medical science
Full name of responsible person
Mansoore ali asgharpour
Position
Educator
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
aliasgha@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical science
Full name of responsible person
Mansoore ali asgharpour
Position
Educator
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6692 7171
Fax
Email
00982166927171
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Taj Mohammad Arazi Ghojegh
Position
MSC student
Other areas of specialty/work
Street address
Gulestan province, Bandar Torkmen, Niazabad
City
Bandar Torkmen
Postal code
4891144495
Phone
+98 17 3422 7439
Fax
Email
tajmohamadarazi@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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