This clinical trial is conducted to assess of the effect of respiratory rehabilitation techniques on respiratory function of COPD patients referring to clinic of khorramabad Shohada hospital. 120 patients with COPD are recruited using convenience sampling method and randomly assigned into control or intervention group. The intervention group receives one session of educational program of respiratory rehabilitation techniques including respiratory exercises and upper limp exercises which will be individualized as necessary using lecture and practical exercises and educational pamphlet. The control group receives no intervention. Any change in arterial blood gases and spirometry measures will be compared between groups. Quality of life was also measured by using standard WHO-QOL questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903194129N1
Registration date:2011-01-03, 1389/10/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-01-03, 1389/10/13
Registrant information
Name
Shirin Hasanvand
Name of organization / entity
Lorestan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 66 1321 3759
Email address
hasanvand.sh@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Sciences
Expected recruitment start date
2010-02-20, 1388/12/01
Expected recruitment end date
2011-08-23, 1390/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The survey of the impact of respiratory rehabilitation techniques on the respiratory functions of chronic obstructive pulmonary disease patients
Public title
The survey of the impact of respiratory rehabilitation techniques on the respiratory functions of chronic obstructive pulmonary disease patients referring to clinic of Shohadaye Ashayer hospital
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Suffering from moderate to severe COPD (emphysema, bronchitis, bronchiectasis), using bronchodilators or mucolytic agents, no change in the treatment protocol
Exclusion Criteria: history of ischemic heart disease or intermittent claudication, presence of renal or liver diseases, skeletal muscle diseases, diabetes or uncontrolled hypertension, consumption of beta agonists or corticosteroid therapy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Lorestan University of Medical Sciences
Street address
Vice-chancellor for Technology and research, Lorestan University of Medical Sciences, University Campus Complex, Khoramabad, Lorestan
City
Khoramabad
Postal code
Approval date
2010-01-09, 1388/10/19
Ethics committee reference number
8-1/10/88
Health conditions studied
1
Description of health condition studied
Choronic Obstructive Pulmonary Diseases
ICD-10 code
J44.9
ICD-10 code description
Choronic Obstructive Pulmonary Diseases
Primary outcomes
1
Description
Arterial Blood Gases
Timepoint
before and after of intervention
Method of measurement
taking 1 cc of arterial blood by educated nurse of ICU ward and reporting of result
2
Description
Repiratory volumes and capacities
Timepoint
before and after intervantion
Method of measurement
spirometery
Secondary outcomes
1
Description
Quality of Life
Timepoint
before and after intervention
Method of measurement
who quality of life questionnaire
Intervention groups
1
Description
Intervention group: Respiratory exercises and Upper limb exercises four times a day for 4 weeks
Category
Rehabilitation
2
Description
Control group: Routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Ashayer hospital
Full name of responsible person
Street address
Shohadaye Ashayer hospital, Khoramabad
City
Khoramabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Shirin Hasanvand
Street address
Lorestan University of Medical Sciences
City
Khoramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan 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
Nursing and Midwifery Colledge
Full name of responsible person
Shirin Hasanvand
Position
Faculty Mentor
Other areas of specialty/work
Street address
Nursing and Midwifery Colledge, Khorramabad, Lorestan
City
Khorramabad
Postal code
Phone
+98 66 1620 0140
Fax
Email
k_p_1026@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lorestan University of Medical Sciences and Health Services
Full name of responsible person
Shirin Hasanvand
Position
Msc
Other areas of specialty/work
Street address
Nursing and Midwiferry Colledge, Khorramabad, Lorestan
City
Khorramabad
Postal code
Phone
+98 66 1620 0140
Fax
Email
k_p_1026@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing and Midwifery college of Khorramabad
Full name of responsible person
Shirin Hasanvand
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)