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Evaluation of changes in Vo2 max after 8 weeks of exercise(on straight,downhill and upright surfaces) in patients with COPD

Protocol summary

Study aim
If aerobic exercise is effective on the downhill or uphill level on increasing vo2max and respiratory function in patients with COPD, regular aerobic exercise can be recommended to improve respiratory function in these patients.
Design
This study will be done on 30 patients with COPD, Patients are randomly divided into three groups of 10 people. level group, downhill group and uphill groups.
Settings and conduct
In this study, three groups of sport activities, including flat surface treadmill exercise (level) group and downhill treadmill exercise (downhill) group and uphill treadmill exercise (uphill) group . in this study Treadmill will be used 3 times per week for 8 weeks, and the duration of physical activity per session is between 30 and 45 minutes based on the patient's ability. at the first, an incremental test is performed for each patient .patients O2Sa are continuously controlled during exercise and in patient with fatigue and inability exercise will be stopped . If the SaO2 drops to less than 88%,the patient receives oxygen If the hypoxia is not corrected, the exercise will stop and the patient is excluded from the study. The vo2 max rate will be measured at the beginning of the study and 8 weeks after exercise
Participants/Inclusion and exclusion criteria
Patients with COPD and body mass index of 19 to 24 without other medical problems, such as heart disease, (including myocardial infarction, myocardial ischemia, cardiac arrhythmia), chronic diseases of the liver, kidney, digestive , musculoskeletal, and central nervous system.
Intervention groups
Level group and downhill group and uphill group: In each group, exercise will be performed 3 times a week for 8 weeks using a treadmill for 30 to 45 minutes.
Main outcome variables
Maximum rate of oxygen consumption (vo2max)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190127042514N5
Registration date: 2020-05-31, 1399/03/11
Registration timing: registered_while_recruiting

Last update: 2020-05-31, 1399/03/11
Update count: 0
Registration date
2020-05-31, 1399/03/11
Registrant information
Name
Halimeh Kameshki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3281 8065
Email address
halimeh.kameshki@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-10, 1398/10/20
Expected recruitment end date
2020-06-09, 1399/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of changes in Vo2 max after 8 weeks of exercise(on straight,downhill and upright surfaces) in patients with COPD
Public title
Evaluation of changes in Vo2 max after 8 weeks of exercise(on straight,downhill and upright surfaces) in patients with COPD
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
COPD patient BMI:19-24 Age: 40-60
Exclusion criteria:
Cardiovascular diseases include recent myocardial infarction, myocardial ischemia, cardiac arrhythmia), Chronic liver diseases Digestive diseases Kidney diseases Musculoskeletal, and central nervous system disorders
Age
From 40 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not 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
Ethics committee of Kerman University of Medical Sciences
Street address
Ibn Sina Ave., Jahad Blvd
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2020-01-01, 1398/10/11
Ethics committee reference number
IR.KMU.AH.REC.1398.162

Health conditions studied

1

Description of health condition studied
Chronic Obstructive Pulmonary Disease
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease

Primary outcomes

1

Description
Maximum rate of oxygen consumption (vo2max)
Timepoint
At the beginning of the study and 8 weeks after exercise
Method of measurement
Shuttle Standard Protocol

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Exercise on the flat surface treadmill :The program for aerobic exercise in this study is use a treadmill with flat surface for 3 times per week for 8 weeks, and the duration of physical activity per session is between 30 to 45 minutes based on the patient's ability.
Category
Rehabilitation

2

Description
Intervention group: Exercise on the downhill surface treadmill :The program for aerobic exercise in this study is use a treadmill with downhill surface for 3 times per week for 8 weeks, and the duration of physical activity per session is between 30 to 45 minutes based on the patient's ability.
Category
Rehabilitation

3

Description
Intervention group: Exercise on the uphill surface treadmill :The program for aerobic exercise in this study is use a treadmill with uphill surface for 3 times per week for 8 weeks, and the duration of physical activity per session is between 30 to 45 minutes based on the patient's ability.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipour Hospital
Full name of responsible person
Dr Rostam Yazdani
Street address
Afzalipour Hospital, Emam Khomeini Highway
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3132 8000
Email
drryazdani@yahoo.com
Web page address
http://www.kmu.ac.ir/fa/ah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Davoud Kalanter
Street address
Ibn Sina Ave ,Jahad Blvd
City
Kerman
Province
Kerman
Postal code
13555-76169
Phone
+98 34 3226 3961
Email
Drshahrzadmirhosseini@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Dr Rostam Yazdani
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Kerman University of Medical Sciences , Haft Bagh e Alavi
City
Kerman
Province
Kerman
Postal code
13555-76169
Phone
+98 34222250
Email
drryazdani@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Rostam Yazdani
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Kerman University of Medical Sciences , Haft Bagh e Alavi
City
Kerman
Province
Kerman
Postal code
13555-76169
Phone
+98 34222250
Email
drryazdani@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr shahrzad mirhosseini
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Kerman University of Medical Sciences , Haft Bagh e Alavi
City
Kerman
Province
Kerman
Postal code
13555-76169
Phone
+98 34222250
Email
Drshahrzadmirhosseini@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No subscription required
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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