To compare the effects of a simple home pulmonary rehabilitation program and hospital-based program on lung function in patients with Chronic Obstructive Pulmonary Disease. Patients in this prospective,
randomized clinical trial were randomized to 2 groups to receive hospital or home pulmonary rehabilitation. Patients with chronic obstructive pulmonary disease will be referred to lung clinic in Tehran scholar Christ's, Thirty patients were randomized to the hospital rehabilitation group and Thirty to the home group. Sampling will be done based on inclusion criteria. Rehabilitation program for 2 months and 3 times a day is done. Patients in the hospital group then carried out a structured exercise program while
home group patients performed low intensity exercises at home that is collected in the form of CD and pamphlet, without supervision. Before and after the end of the second month, lung function in patients is measured whit spirometry, 6-minute walk test and criterion of dyspnea whit questionnaire of MMRC. The expected impact in this study, pulmonary rehabilitation program at home as in a hospital rehabilitation program are effective on pulmonary function in patients, the 6-minute walk test and reducing dyspnea
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010720600N1
Registration date:2016-06-26, 1395/04/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-26, 1395/04/06
Registrant information
Name
Fateme Tavanaiee Yosefian
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
tavanaeif911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Financial Assistance Mashhad University of Medical Sciences
Expected recruitment start date
2015-08-11, 1394/05/20
Expected recruitment end date
2015-12-11, 1394/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of home-based and hospital-based pulmonary rehabilitation on lung function in patients with Chronic Obstructive Pulmonary Disease
Public title
pulmonary rehabilitation in Chronic Obstructive Pulmonary Disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:have the desire to participate in the study؛ live in Mashhad; they have over 35 years of age; spoke Persian; confirmed diagnosis of COPD is confirmed by a physician and clinical results; signs of infection or exacerbations (Acute Exacerbation) based on the baseline examination by specialists not have lungs; history is not in favor of exacerbations in the past month; ability to participate in the rehabilitation program based on initial medical examination have rehabilitation medicine specialist; chronic diseases such as heart failure, coronary artery disease, other diseases known respiratory, kidney disease, arthritis, severe knee arthritis, cancer and depression is not active; history of participation in the rehabilitation program, is not; the ability to have a relationship with the researcher.
Exclusion criteria:refuse to participate in a research study and work with it; The absence of training sessions (4 sessions 3 sessions intermittent or continuous) have; exacerbation of symptoms during the rehabilitation program; Symptoms of angina, shortness of breath and severe hypoxia (Sat O2 <85%) occur during the rehabilitation program; Patients in the hospital for any reason (- Surgical) hospital.
Age
From 59 years old to 15 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
Sample selection was done based on random assignment and table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Four ways PhD, School of Nursing and Midwifery, Mashhad Jarjani
City
Mashhad
Postal code
Approval date
2015-08-01, 1394/05/10
Ethics committee reference number
IR.MUMS.REC.1394.103
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
Improvement lung function
Timepoint
Before and after the intervention.
Method of measurement
Spirometric parameters, 6 minute walk test and the severity of dyspnea
Secondary outcomes
1
Description
health-related quality of life
Timepoint
Before and after the intervention
Method of measurement
St. George's questionnaire
Intervention groups
1
Description
Home rehabilitation group includes protocol designed and applicable in the patient's home the 4 components endurance training, resistance training, flexibility exercises and breathing exercises have been formed. And training programs for CD and pamphlet will be given for the patients. Patient rehabilitation program 3 times a week, with each session scheduled for 8 weeks doing
Category
Rehabilitation
2
Description
Group rehabilitation of the hospital designed the hospital protocol of 4 components endurance training, resistance training, flexibility exercises and breathing exercises have been formed. And patients attending specialist training in sports medicine are doing. Patient rehabilitation program 3 times a week, with each session scheduled for 8 weeks doing
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Lung Clinic of Dr. Masih Daneshvari Hospital
Full name of responsible person
Fateme Tavanaiee Yosefian
Street address
Dar Abad, Aghdasiyeh, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr. tafaghodi
Street address
Daneshgah street; Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Fateme Tavanaiee Yosefian
Position
MSc in Nursing, Critical Care
Other areas of specialty/work
Street address
Mashhad University of Medical Sciences
City
Mashhad
Postal code
Phone
+98 51 3840 8992
Fax
Email
tavanaeif911@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mahhad University of Medical Sciences
Full name of responsible person
Tayebe Porghaznein
Position
MSc Nursing, Lecturer, Faculty member of Mahhad University of Medical Sciences
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Mahhad University of Medical Sciences
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
pourghazneint @mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fateme Tavanaiee Yosefian
Position
MSc in Nursing, Critical Care
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Mahhad University of Medical Sciences
City
Mashhad
Postal code
Phone
00
Fax
Email
tavanaeif911@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)