This study compared the use of inspiratory resistive muscle training (IMT) by powerbreathe to incentive spirometry on selected measures of pulmonary function and dyspnea. A total of 30 stable patients with moderate COPD (FEV1/ FVC<70%, FEV1<80% predicted) according to the criteria of the American Thoracic Society were randomly assigned to either an IMT or IS treatment group. All subjects were trained daily in two sessions of 15 minute each, 4 days a week, for 4 weeks. In the IMT group, the training was performed using a threshold inspiratory muscle trainer (POWERbreathe; Gaiam Ltd; Southam, Warwickshire, UK). In the IS group the training was performed using a volumetric exercisers (Respiflo; Tyco Health Care Ltd; UK). Functional lung parameters, respiratory pattern and dyspnea were compared in the both training groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105096422N1
Registration date:2011-10-02, 1390/07/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-10-02, 1390/07/10
Registrant information
Name
Marjan Farzad
Name of organization / entity
Mashhad University of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 56 1443 7622
Email address
farzadm881@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University Of Medical Sciences
Expected recruitment start date
2011-04-30, 1390/02/10
Expected recruitment end date
2011-08-01, 1390/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of inspiratory resistive muscle training with incentive spirometer on improving respiratory function and dyspnea in COPD patients
Public title
Respiratory rehabilitation in lung disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Obtaining informed consent, The chronic obstructive pulmonary disease diagnosed and confirmed by lung specialist and through paraclinical tests; fev1<80% predicted and fev1/fvc<70% (stageII, stable patients); clear Lungs, age 40-65; basic spirometry other than "Asthma"; No smoking at least for 3 months
Exclusion criteria: Refuse to participate in research; not taking part in training for 4 weeks prior to the study; fever or respiratory infection; Respiratory or cardiac failure
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Mashhad University Of Medical Sciences
Street address
Vice-chancellor for Reseach, Mashhad University of Medical Sciences, Daneshgah Street, Mashhad
simple and mucopurulent chronic bronchitis,Emphysema
Primary outcomes
1
Description
Maximal Voluntary Ventilation
Timepoint
before intervention, end of week 2, end of week 4
Method of measurement
L/m, by Hi 801 spirometer
2
Description
PImax
Timepoint
before intervention, end of week 2, end of week 4
Method of measurement
Cm/H20, mouth pressure meter
3
Description
Forced Vital Capasity
Timepoint
before intervention, end of week 2,end of week 4
Method of measurement
L, by Hi 801 spirometer
4
Description
Peek Expiratory Flow Rate
Timepoint
before intervention, end of week 2, end of week 4
Method of measurement
L/s, by Hi 801 spirometer
5
Description
Forced Expiratory Volume in One Second
Timepoint
before intervention, end of week 2, end of week 4
Method of measurement
L, by Hi 801 spirometer
6
Description
Tidal Volume
Timepoint
before intervention, end of week 2, end of week 4
Method of measurement
L, by Hi 801 spirometer
7
Description
Respiratory Rate
Timepoint
before intervention, end of week 2, end of week 4
Method of measurement
Count chest rising and coming down for one full minute, by watch OMax
Secondary outcomes
1
Description
dyspnea
Timepoint
befor intervention, end of week 2, end of week4
Method of measurement
Numerical Rating Scale (0-10)
2
Description
Respiratory pattern
Timepoint
before intervention, end of week 2. end of week 4
Method of measurement
with measuring depth of respiration (according to tidal volume, L) and respiratory rate by watch, Breath/minute
Intervention groups
1
Description
Intervention 1: the training was performed using a volumetric exercisers (Respiflo; Tyco Health Care Ltd; UK)/ 10 to 15 times in two sessions of 15 minutes each morning and in the afternoon /4 days a week for 4 weeks.
Category
Rehabilitation
2
Description
Intervention2: the training was performed using a threshold inspiratory muscle trainer (POWERbreathe; Gaiam Ltd; Southam, Warwickshire, UK)/ daily in two sessions of 15 minute each morning and in the afternoon/4 days a week, for 4 weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Emamreza Hospital, Mashhad
Full name of responsible person
Dr. Hossein Ahmadihoseiny, Lung Specialist, assistant professor of mashhad University of medical sci
Street address
Emamreza sq, Ebnesina street, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences, Research Section
Full name of responsible person
Dr. Mohammad Ramezani
Street address
Ghoraishi Building, Research section, Daneshghah Street, Mashhad
City
Mashhad
Grant name
شماره663/511
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences, Research Section
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 Nursing and midwifery
Full name of responsible person
Abbas Heidary, Ph.D, Assistant professor of Mashhad University of Nursing and Midwifery
Position
PH.D in nursing
Other areas of specialty/work
Street address
Doktora Blvd, Ebnesina Street, Mashhad
City
Mashhad
Postal code
9137913199
Phone
+98 51 1854 8884
Fax
+98 51 1859 7313
Email
اheidarya@mums.ac.ir
Web page address
www.mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Ahmadihosseini
Position
Assistant Professor of Internal Group of Mashhad University of Medical Science, Lung Specialist
Other areas of specialty/work
Street address
Emamreza Square, Emamreza Hospital
City
Mashhad
Postal code
9137913316
Phone
+98 51 1854 3031
Fax
+98 51 1859 1057
Email
Ahmadihh@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
Marjan Farzad
Position
MSc, Master of nursing
Other areas of specialty/work
Street address
Doktora Blvd, Ebnesina Street
City
Mashhad
Postal code
9137913199
Phone
+98 51 1854 8884
Fax
+98 51 1859 7313
Email
farzadm881@mums.ac.irmarjan_farzad@mums.ac.ir
Web page address
www.mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)