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Effects of pulmonary rehabilitation before and after open cardiac surgery on respiratory function

Protocol summary

Summary
It seems that inspiratory muscles training (IMT) can improve rehabilitation process of patients that are candidate for open heart surgery. We want to compare the outcomes of pulmonary function of patients with spirometry, arterial blood gases (ABG), 6 minutes walking test (6MWT) between 2 groups of them with and without IMT performed before surgery. We will perform inspiratory muscles training for 30 patients for 15 sessions before surgery and compare outcomes among them and control group (each 30 patients). Inclusion criteria are patients that undergo open heart surgery. Exclusion criteria are: 1.history of chronic obstructive pulmonary disease (COPD), 2.emergent surgery, 3.history of congestive heart failure (CHF).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138904294422N1
Registration date: 2010-09-28, 1389/07/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-09-28, 1389/07/06
Registrant information
Name
Seyed Kazem Shakouri
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 3518
Email address
shakourik@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz university of medical scinces
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-08-29, 1390/06/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of pulmonary rehabilitation before and after open cardiac surgery on respiratory function
Public title
Effects of pulmonary rehabilitation before and after open cardiac surgery on respiratory function
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients that undergo open cardiac surgery. Exclusion criteria: 1.Chronic obstructive pulmonary disease (COPD), 2.emergency surgery, 3.Congestive heart failure (CHF).
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice chancellor for research of Tabriz universityn of medical sciences
Street address
Tabriz university of medical sciences
City
Tabriz
Postal code
Approval date
2010-07-05, 1389/04/14
Ethics committee reference number
2722/4/5

Health conditions studied

1

Description of health condition studied
Patients that undergo open heart surgery
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease

Primary outcomes

1

Description
effect on spirometry
Timepoint
15 days
Method of measurement
Spirometry instrument

Secondary outcomes

1

Description
Arterial Blood Gases (ABG)
Timepoint
according to ward routin evaluations
Method of measurement
ABG instrument

Intervention groups

1

Description
1.Cervical and shoulder mobilization, 2.Respiratory exercises, 3.IS training and cough training, 4.Stretching exercises of shoulder.
Category
Rehabilitation

2

Description
Control group: Incentive spirometry training and effective cough training.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Shaheed Madani hospital
Full name of responsible person
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr. Rasool Azarfarin
Street address
Vice chancellor for research of Tabriz university of medical sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz university of medical sciences
Full name of responsible person
Dr. Seyyed Kazem Shakoury
Position
Head of physical medicine ward
Other areas of specialty/work
Street address
Physical medicine and rehabilitation ward, Tabriz university of medical sciences
City
Tabriz
Postal code
Phone
+98 41 1337 3954
Fax
Email
shakourik@tbzmed.ac.ir , jamalsoleimani56@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Physical medicine and rehabilitation ward of Emam Reza hospital
Full name of responsible person
Dr. Seyyed Kazem Shakoury
Position
Physical medicine and rehabilitation proffesional, MD
Other areas of specialty/work
Street address
Emam Reza hospital, University street
City
Tabriz
Postal code
Phone
+98 41 1337 3954
Fax
Email
shakourik@tbzmed.ac.ir , jamalsoleimani56@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Dr. Seyyed Kazem Shakouri
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
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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