Effect of rehabilitation with and without Non Invasive Ventilation on change in pulmonary function and CAT scores of COPD patients at Masih Daneshvari Hospital
Objective: Effect of rehabilitation with and without non-invasive ventilation on lung function and COPD assessment test particularly for patients admitted to Masih daneshvari hospital in autumn and winter 1395.
Study design: Randomized, double-blind, placebo-controlled, single-center, phase two and three trials.
Study population: all patients with chronic obstructive pulmonary disease referring to Masih daneshvari hospital in the fall and winter of 1395
Inclusion criteria: (1) identifying chronic obstructive pulmonary disease, (2) the satisfaction of participating in the study, (3) the Consciousness to complete the tests
Exclusion criteria: (1) inability to carry out the rehabilitation, (2) the occurrence of exacerbation or disease attack
Sample Size: 50
Interventions include breathing exercises and physical therapy, pulmonary rehabilitation program (3 times a week 3 weeks) and concurrent use of non-invasive ventilation
Implications of the study: the distance walked in 6-minute walk test, measurement values: venous blood gas analysis, pulmonary function tests, Chronic Obstructive Pulmonary Diseases assessment questionnaire
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102927929N3
Registration date:2017-02-14, 1395/11/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-14, 1395/11/26
Registrant information
Name
Atefeh Fakharian
Name of organization / entity
National research institute of tuberculosis and lung diseases
Country
Iran (Islamic Republic of)
Phone
+98 21 2712 2541
Email address
afakharian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-03-18, 1395/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of rehabilitation with and without Non Invasive Ventilation on change in pulmonary function and CAT scores of COPD patients at Masih Daneshvari Hospital
Public title
Effect of rehabilitation with and without Non Invasive Ventilation among COPD subjects
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: identifying chronic obstructive pulmonary disease; the satisfaction of participating in the study; The Consciousness of subjects
Exclusion criteria: inability to carry out rehabilitation; the occurrence of exacerbation or disease attack
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-Chancellor in Research Affairs of Shahid Beheshti University of Medical Sciences
Control group: 3 session/week for 3 weeks of rehabilitation including respiratory exercise and exercise therapy and Non invasive ventilation mask while the device is off.
Category
Treatment - Devices
2
Description
Intervention group: 3 sessions/ week for 3 weeks of rehabilitation including respiratory exercise and exercise therapy and Non Invasive Ventilation while the device is on.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih daneshvari hospital
Full name of responsible person
Marzie Mobininezhad
Street address
Darabad Avenue, Shahid Bahonar roundabout
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research ofShahid Beheshti University of Medical Sciences