Objective: determination the effect of pulmonary rehabilitation program on quality of life and activity tolerance in patients with chronic obstructive pulmonary disease, study: RCT, parallel, not blinded, convenient sampling. Inclusion criteria: 1) be younger than 75 years old, 2) they should be literate, 3) they should have healthy vision and hearing, 4) it should be possible to make phone calls directly to the patient's home. Exclusion criteria: 1) enter to the acute phase of severe or the patient dies during the study, 2) if patient does not adhere to the exercise program because of new physical limitations, 3) if patient does not do more than two sessions of exercise and breathing, 4) if the patient does not adhere to the nutritional recommendations in a week. sample size: 60. The number of patients participating in this study are 60 patients with chronic obstructive pulmonary disease admitted to hospital ¬ Firoozgar and Imam Khomeini (RA). The patients have been randomly divided into two groups, intervention (n=30) and control (n=30) groups. The control group will receive only routine care and the intervention group will participate in pulmonary rehabilitation program for 8 weeks in addition to the usual care.Then rehabilitation program telephone follow-up will be done in-home for once a week. outcome: to improve the quality of life and activity tolerance in intervention conditions.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT201203135987N4
Registration date:2013-04-16, 1392/01/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-04-16, 1392/01/27
Registrant information
Name
Shahrzad Ghiyasvandian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
shghiyas@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Expected recruitment start date
2012-08-12, 1391/05/22
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
The effect of pulmonary rehabilitation on quality of life and activity tolerance of COPD patients
Public title
Effect of pulmonary rehabilitation on life of pulmonary diseases patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: all case studies will sign an informed consent, and also they should have the following conditions: 1) Be younger than 75 years old. 2) Not be in the acute phase of the disease. 3) Not have any known defect in the respiratory system caused by other diseases. 4) Not have motor impairment which prevents their exercise. 5) They should be literate. 6) They should have healthy vision and hearing system. 7) It should be possible to make phone calls directly to the patient's home.
Exclusion criteria: In this study, if a patient has one of following characteristics, it will be excluded from the study: 1) Enter to the acute phase of severe or the patient dies during the study. 2) If patient does not adhere to the exercise program because of new physical limitations. 3) If patient does not do more than two sessions of exercise and breathing. 4) If the patient does not adhere to the nutritional recommendations in a week.
Age
From 18 years old to 75 years old
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)
Not 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 Sciences Ethics Committee
Street address
Tehran, Keshavarz blvd, Ghods st.
City
Tehran
Postal code
1419733171
Approval date
2012-08-12, 1391/05/22
Ethics committee reference number
1105/130/ص/91
Health conditions studied
1
Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease
Primary outcomes
1
Description
Health-related quality of life
Timepoint
Pre test, 8 week after intervention
Method of measurement
sf-36 Questionnaire
Secondary outcomes
1
Description
Activity tolerance
Timepoint
Pre test, 8 week after intervention
Method of measurement
St. George's Questionnaire
Intervention groups
1
Description
Pulmonary rehabilitation program was provided on self-care training, nutritional advice, psychological interventions through education of techniques reduction stress, strategies for effective breathing, shortness of breath control strategies in crisis, clean up the air by coughing and effective strategies and exercise program. Care education program includes anatomy and physiology respiratory system, pathophysiology, drug therapy, oxygen therapy, nutritional advice and training for coping with stress. In addition to the face-to-face training was given to the cases of the study were given a booklet. Training materials pulmonary rehabilitation program by the researcher during the three sessions will run for 30 minutes. Patients three times a week for 8 weeks for 20 minutes each time from 5 minutes to 20 minutes, which gradually increased, training exercises were conducted. Follow up was conducted by the researcher once a week for a maximum of 15 minutes.
Category
Rehabilitation
2
Description
In the control group,Routine care which included without scheduling training the use of drugs, oxygen therapy and deep breathing can be performed.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Firozgar Hospital
Full name of responsible person
Keyvan KHodayari
Street address
Beh Afarin Street, Karim Khan Zand Street.
City
Tehran
2
Recruitment center
Name of recruitment center
Imam Khomeyni Hospital
Full name of responsible person
Keyvan Khodayari
Street address
Tehran, Tohid Square.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research, Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Dr Azam Baheiraei
Street address
Tehran, tohid sq, Faculty of nursing and midwifery, University of Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research, Faculty of Nursing and Midwifery, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Keyvan KHodayari
Position
Master of Nursing
Other areas of specialty/work
Street address
Tehran, tohid sq, Faculty of nursing and midwifery, University of Tehran
City
Tehran
Postal code
1419733171
Phone
+98 21 6642 0739
Fax
Email
keyvankhodayari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr shahrzad Ghiyasvandiyan
Position
Assistant Professor
Other areas of specialty/work
Street address
Tehran, tohid sq, Faculty of nursing and midwifery, University of Tehran
City
Tehran
Postal code
1419733171
Phone
+98 21 6642 0739
Fax
Email
shghiyas@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Keyvan Khodayari
Position
Master of Nursing
Other areas of specialty/work
Street address
Tehran, tohid sq, Faculty of nursing and midwifery, University of Tehran
City
Tehran
Postal code
1836775571
Phone
+98 21 8214 1210
Fax
keyvankhodayari@yahoo.com
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)