Determining the physical and psychological effects of pulmonary rehabilitation program in patients with chronic obstructive pulmonary disease
Design
One- group before- after clinical Trial without blinding
Settings and conduct
Selecting 47 patients with chronic obstructive pulmonary disease referring to lung clinic or hospitalized in the lung/ general internal medicine ward at Shariati hospital affiliated to Tehran university of medical sciences.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to GOLD criteria (I to IV); and Occurrence of exacerbation.
Exclusion Criteria: Contraindication for pulmonary rehabilitation; No compliance with the program; psychiatric disorders; with uncontrolled cardiovascular diseases; disability for doing the program.
Intervention groups
Implementation of pulmonary rehabilitation program including training of breathing exercises at home and aerobic exercise program according to the American Association of Cardiovascular and Pulmonary Rehabilitation (AACPR) including respiratory muscle training, respiratory techniques and the way to discharge lung secretions, twice a week about 30 to 60 minutes for eight weeks according to patient`s tolerance by sport medicine specialist in pulmonary rehabilitation clinic at Shariati hospital affiliated to Tehran university of medical sciences.
Main outcome variables
Assessment of pulmonary function, ability of walking, shortness of breath, health- related quality of life, anxiety and depression before and 1 week after finishing the pulmonary rehabilitation program.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170210032476N2
Registration date:2018-03-09, 1396/12/18
Registration timing:retrospective
Last update:2018-03-09, 1396/12/18
Update count:0
Registration date
2018-03-09, 1396/12/18
Registrant information
Name
Mahin Nomali
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
m-nomali@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-01-29, 1395/11/10
Actual recruitment start date
2016-04-20, 1395/02/01
Actual recruitment end date
2017-02-03, 1395/11/15
Trial completion date
empty
Scientific title
Physical and Psychological Effects of Pulmonary Rehabilitation Program in Patients with Chronic Obstructive Pulmonary Disease
Public title
Effects of Pulmonary Rehabilitation Program in Patients with Chronic Obstructive Pulmonary Disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients that are with the Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) according to the GOLD criteria (I to IV).
Patients that are with the disease exacerbation.
Exclusion criteria:
There is contraindication for pulmonary rehabilitation.
Patients do not adhere to the program.
Patients who are with psychiatric disorders such as dementia.
Patients who are with uncontrolled cardiovascular diseases.
Patients that can not do the program due to orthopedic issues, diabetes; and uncontrolled liver disease.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
47
Actual sample size reached:
22
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Building no.1, Northern gate of the university, Poursina St. Qods St. Enqelab St.
Before initiation of the study and one week after finishing the pulmonary rehabilitation program.
Method of measurement
St. George questionnaire and SF-12
Secondary outcomes
1
Description
Pulmonary function
Timepoint
Before initiation of the study and one week after finishing the pulmonary rehabilitation program.
Method of measurement
Spirometry
2
Description
Walking ability
Timepoint
Before initiation of the study and one week after finishing the pulmonary rehabilitation program.
Method of measurement
6- minute Walk Test
3
Description
Shortness of breath
Timepoint
Before initiation of the study and one week after finishing the pulmonary rehabilitation program.
Method of measurement
Medical Research Council Questionnaire
4
Description
Anxiety and Depression
Timepoint
Before initiation of the study and one week after finishing the pulmonary rehabilitation program.
Method of measurement
Hospital Anxiety and Depression Scale
Intervention groups
1
Description
Intervention group: Implementation of pulmonary rehabilitation program including training of breathing exercises at home and aerobic exercise program according to the American Association of Cardiovascular and Pulmonary Rehabilitation (AACPR) including respiratory muscle training, respiratory techniques and the way to discharge lung secretions, twice a week about 30 to 60 minutes for eight weeks according to patient`s tolerance by sport medicine specialist in pulmonary rehabilitation clinic at Shariati hospital affiliated to Tehran university of medical sciences.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital affiliated to Tehran University of Medical Sciences
Full name of responsible person
Dr. Zeinab Naderpour
Street address
North Karegar St., Three Way Jalal Al-Ahmad, Shariati Hospital affiliated to Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14117131352
Phone
+98 21 8490 1000
Email
z-naderpour@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammadali Sahraian
Street address
Keshavarz Blvd., Qods street, Research deputy of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
141556559
Phone
+98 21 8163 3698
Email
msahrai@tuma.ac.ir
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 Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Farnaz Mohammadnejad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
North Kargar St., 3 Way Jalal Al-Ahmad, Shariati Hospital affiliated to Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 2257 2536
Email
frnzmohammadnezhad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Zeinab Naderpour
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
North Kargar St., 3 Way Jalal Al-Ahmad, Shariati Hospital affiliated to Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 2257 2536
Email
z-naderpour@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Farnaz Mohammadnejad
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
North Kargar St., 3 Way Jalal Al-Ahmad, Shariati Hospital affiliated to Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 2257 2536
Email
frnzmohammadnezhad@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
All rights related to the data is for Tehran University of Medical Sciences.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data will be shared after making characteristics of the persons, unrecognizable.
When the data will become available and for how long
Initiation of the data availability 6 months after publication of the results
To whom data/document is available
All researchers
Under which criteria data/document could be used
Using in the systematic review and meta-analysis
From where data/document is obtainable
Tehran University of Medical Sciences
What processes are involved for a request to access data/document
Providing a request and receiving the university approval letter