Protocol summary

Summary
This clinical trial aimed to deternine the effect of inspiratory muscle training on quality of life,dyspnea,exercise tolerance and pulmonary function test of COPD patients. A total 30 COPD patients were randomly assigned into Inspiratory muscle training group and control group, the patients trained at home daily for 21 minutes,6 days per week for 8 weeeks. dyspnea, exercise tolerance, PFT and QOL were measured and compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201104266299N1
Registration date: 2011-09-22, 1390/06/31
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-09-22, 1390/06/31
Registrant information
Name
Maryam Bakhshandeh Bavarsad
Name of organization / entity
School of Nursing and Midwifery, Jondi Shapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1377 7216
Email address
bavarsad.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jondi Shapur University of Medical Sciences
Expected recruitment start date
2011-02-20, 1389/12/01
Expected recruitment end date
2011-06-19, 1390/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of inspiratory muscle training on clinical status indicators and quality of life in COPD patients
Public title
The effect of inspiratory muscle training in COPD patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: COPD patients with mild to very severe degree, having established a treatment plan, Having a BMI less than 35, Absence of other diseases such as neurological disorders, musculoskeletal system, peripheral vascular disease, not heart attack, Independence to the long-term oxygen therapy Exclusion criteria:Changes in treatment plan during the study
Age
From 45 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
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Jondi Shapur University of Medical Sciences-School of Nursing and Midwifery
Street address
Jundishapur University of Medical Sciences, School of Nursing and Midwifery, Golestan Highway, Ahvaz
City
Ahvaz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
ETH-126

Health conditions studied

1

Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
J44.9
ICD-10 code description
chronic obstructive pulmonary disease, unspecified

Primary outcomes

1

Description
dyspnea
Timepoint
Baseline and the end of 8 weeks
Method of measurement
Borg scale

Secondary outcomes

1

Description
Quality of life
Timepoint
Baseline and the end of 8 weeeks
Method of measurement
St,george quality of life

Intervention groups

1

Description
Case group:inspiratory muscle training 6 daye per week, 21 minutes for 8 weeks
Category
Rehabilitation

2

Description
Control group: Resived no intervation
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Aria Specialized and Ultra Specialized Hospital
Full name of responsible person
Dr. Ismail Idani
Street address
Aria Hospital, Kianpars, Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jondi Shapur University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi, Vice-Chancellor for Research
Street address
Jondi Shapur University of Medical Sciences, School of Nursing and Midwifery
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jondi Shapur 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
School of Nursing and Midwifery, Jondi Shapur University of Medical Science
Full name of responsible person
Maryam Bakhshandeh Bavarsad
Position
Master of Science in Nursing
Other areas of specialty/work
Street address
Jondi Shapur University of Medical Sciences, School of Nursing and Midwifery, Golestan Highway ,Ahwaz
City
Ahvaz
Postal code
Phone
+98 61 1377 7216
Fax
Email
bavarsad.m@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery, Jondi Shapur University of Medical Sciences,
Full name of responsible person
Abdolali Sharyati
Position
Master of Science in Nursing and a faculty member
Other areas of specialty/work
Street address
Jondi Shapur University of Medical Sciences, School of Nursing and Midwifery, Golestan Highway ,Ahwaz
City
Ahvaz
Postal code
Phone
+98 61 1377 7216
Fax
Email
bavarsad.m@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing and Midwifery, Jondi Shapur University of Medical Sciences
Full name of responsible person
Maryam Bakhshandeh Bavarsad
Position
Master of Science in Nursing
Other areas of specialty/work
Street address
Jondi Shapur University of Medical Sciences, School of Nursing and Midwifery, Golestan Highway ,Ahwaz
City
Ahvaz
Postal code
Phone
Fax
Email
bavarsad.m@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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