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The assessment of effectiveness of respiratory muscle training (I M T)and aerobic training on quality of life in patients with chronic obstructive pulmonary disease(C O P D)

Protocol summary

Study aim
Comparison of the Effect of Two Methods of Dementia Respiratory Muscle Exercise and Aerobic Exercise in Patients with C.O.P.D in Imam Hussein Hospital in 2016
Design
The first group (n = 16) treated with the I.M.T method in the second group (n = 14) received the aerobic exercise method in the third group (n = 15) in the fourth group (n = 15) (control group)
Settings and conduct
Hospital but Hussein Department of Physiotherapy
Participants/Inclusion and exclusion criteria
Satisfaction to participate in the study, Getting Grade 2 or 3 Based on GOLD Criteria, Age 40 to 70 years, Lack of other pulmonary diseases, Lack of severe limb limbs, Lack of pulmonary surgery in the last 12 months, Recent fracture failure at the level of ribs (6 months), No history of psychotropic disease and related drugs and alcohol and psychotropic substances.
Intervention groups
The first group (n = 16) was treated by IMT: the intensity of training was 40-60% (S-Index 40-60%), 2 days per week, and 5 sessions of dermal muscle training with repeat 50 (5 Repeat 10) for about 15 minutes per session. The second group (n = 14) was treated with aerobic exercise method: with a treadmill and foot pedometer, 2 times a week, with 40 to 60% HRR for 40 minutes per session. The third group (n = 15) received combined therapy (in each session, breathing exercises were performed first and then aerobic exercises were performed on the lower extremities) The fourth group (n = 15) did not take any special intervention other than the usual treatments (control group)
Main outcome variables
Evaluation of pulmonary function according to spirometry (FEV1); Testing of respiratory muscles with the IMT Test Power Breath device to determine the S-index; Dyspnea severity: based on the MMRC classification; 6-minute walk test (6MWD); The severity of COPD was assessed by two methods: A-GOLD BODE INDEX. Health-related quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180205038633N1
Registration date: 2019-03-17, 1397/12/26
Registration timing: retrospective

Last update: 2019-03-17, 1397/12/26
Update count: 0
Registration date
2019-03-17, 1397/12/26
Registrant information
Name
Saeid Rezaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8823 0532
Email address
saeedrezaee1394@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-05-21, 1396/02/31
Actual recruitment start date
2017-05-22, 1396/03/01
Actual recruitment end date
2017-07-23, 1396/05/01
Trial completion date
empty
Scientific title
The assessment of effectiveness of respiratory muscle training (I M T)and aerobic training on quality of life in patients with chronic obstructive pulmonary disease(C O P D)
Public title
The assessment of effectiveness of respiratory muscle training (I M T)and aerobic training in patients with pulmonary disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study Getting Grade 2 or 3 Based on GOLD Criteria Age 40 to 70 years Failure to have previous known disease, such as heart disease (such as C.H.F and coronary artery disease), or disease of the lungs (E.S.R.D and C.R.F), and liver (cirrhosis of the liver, cancer, etc.) Lack of other pulmonary diseases, such as lung cancer, plural disease, or musculature involvement. The lack of extreme limbs that prevent aerobic exercise Lack of pulmonary surgery in the last 12 months Recent fracture failure at the level of ribs (6 months) No history of psychotropic disease and related drugs and alcohol and psychotropic substances
Exclusion criteria:
Failure to have previous known disease, such as heart disease (such as C.H.F and coronary artery disease), or disease of the lungs (E.S.R.D and C.R.F), and liver (cirrhosis of the liver, cancer, etc.)
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 68
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
block randomization
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
Ethics committee of Shahid beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2016-06-21, 1395/04/01
Ethics committee reference number
IR.SBMU. MSP.REC.1395.146

Health conditions studied

1

Description of health condition studied
Chronic bronchitis-emphysema
ICD-10 code
J41-J43
ICD-10 code description
Emphysema Excl.: emphysema-Simple and mucopurulent chronic bronchitis

Primary outcomes

1

Description
Spirometric FEV 1 Index - Quality of Life Indicator score
Timepoint
Beginning of study - Week 4 - Week 8
Method of measurement
Lung Spirometry - St. George's Quality of Life Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: -
Category
Rehabilitation

2

Description
ٍExercise group and respiratory training
Category
Rehabilitation

3

Description
Intervention group: Respiratory training group
Category
Rehabilitation

4

Description
Control group: no intervention
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Saeed Razaei
Street address
ُShahid Madani Avenue Nizam Abad Tehran
City
Tehran
Province
Tehran
Postal code
1841.1809.53
Phone
+98 21 7343 0000
Email
saeedrezaee1394@sbmu.ac.com
Web page address
http://www.ehmc.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr seyed ali ziyayi
Street address
elenjak taleghani hospital
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Fax
+98 21 2243 2570
Email
info@sbmu.ac.ir
Web page address
http://www.sbmu.ac.ir
Grant name
Deputy of Research of Shahid Beheshti University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr amirhosseion abedi yekta
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Velenjak ShahidAbrabi St. Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
021230311 - 02122432560-9
Fax
+98 21 2243 2570
Email
Abedi_yekta@yahoo.com
Web page address
https://taleghani.sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed rezaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Velenjak Taleghani Hospital
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21224325609
Fax
+98 21 2243 2570
Email
saeedrezaee1394@sbmu.ac.ir
Web page address
https://taleghani.sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed rezaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Velenjak-taleghani chospital
City
Tehran
Province
Tehran
Postal code
021-22432570
Phone
+98 21224325609
Fax
+98 21 2243 2570
Email
saeedrezaee1394@sbmu.ac.ir
Web page address
https://taleghani.sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Dissertation and some with information about the consequences of patients without mentioning patients' characteristics
When the data will become available and for how long
Possibility of post-publication of the article
To whom data/document is available
Researchers and students from all over the country
Under which criteria data/document could be used
Clinical research similar to the direction of relevant researchers
From where data/document is obtainable
Theses and articles of research deputy of Shahid Beheshti University of Medical Sciences
What processes are involved for a request to access data/document
Through a reputable service center at a different country and adhering to the principles of copyright
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