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Comparison of the affect of an aerobic exercise on the downhill, level and uphill surface together, on the leptin/adiponectin ratio in COPD patients

Protocol summary

Study aim
If the aerobic exercise activity is effective on the downhill or uphill levels, increasing the leptin to adiponectin ratio and respiratory function in patients with COPD, regular aerobic exercise can be ecommended to improve respiratory function in these patients.
Design
This study was conducted on 30 patients with COPD, randomly divided into three groups of 10 people. Level group and downhill group and uphill group
Settings and conduct
In this study, three groups of sports activities, including treadmill flat surface exercise (level) and treadmill surface slope exercise (downhill) and treadmill high level exercise (uphill) in this study uses treadmill, 3 times per week for 8 weeks, and the duration of physical activity per session is between 30 and 40 minutes based on the patient's ability. Prior to each patient, an incremental test is performed during exercise, SaO2 patients are continuously controlled and in the event of fatigue and inability of the patient to interrupt exercise. If the SaO2 drops to less than 88%, the patient receives oxygen and if the hypoxia is not corrected, the activity is discontinued and the patient is excluded from the study. The blood sample was taken before and after exercise, and the Leptin and Adiponectin levels were measured
Participants/Inclusion and exclusion criteria
Patients with COPD and body mass index of 19 to 24 non-patients with 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 is performed using treadmill 3 times per week for 8 weeks and for 30 to 40 minutes
Main outcome variables
Leptin; Adiponectin

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190127042514N3
Registration date: 2020-01-13, 1398/10/23
Registration timing: retrospective

Last update: 2020-01-13, 1398/10/23
Update count: 0
Registration date
2020-01-13, 1398/10/23
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
2019-04-25, 1398/02/05
Expected recruitment end date
2019-11-06, 1398/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the affect of an aerobic exercise on the downhill, level and uphill surface together, on the leptin/adiponectin ratio in COPD patients
Public title
Comparison of the affect of an aerobic exercise on the downhill, level and uphill surface together, on the leptin/adiponectin ratio in COPD patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
COPD patients BMI:19-24 Age: 40-60
Exclusion criteria:
Cardiovascular diseases include recent myocardial infarction, myocardial ischemia, cardiac arrhythmia), Chronic liver diseases Digestive diseases Musculoskeletal, and central nervous system disorders Kidney diseases
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
2019-03-18, 1397/12/27
Ethics committee reference number
IR.KMU.AH.REC.1397.173

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
Serum Leptin levels
Timepoint
Blood samples were taken from patients before and after exercise, and their leptin levels were measured and leptin / adiponectin ratios measured and compared before and after exercise.
Method of measurement
Blood serum sample

2

Description
Serum Adiponectin levels
Timepoint
Blood samples were taken from patients before and after exercise, and their adiponectin levels were measured and leptin / adiponectin ratios measured and compared before and after exercise.
Method of measurement
Blood serum sample

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: sports activity on the flat surface treadmill. The program for aerobic exercise in this study, using a treadmill on a flat surface, 3 times per week for 8 weeks, and the duration of physical activity per session is between 30 to 40 minutes based on the patient's ability.
Category
Rehabilitation

2

Description
Intervention group: sports activity on the downhill surface treadmill .The program for aerobic exeracise in this study, using a treadmill on a downhill surface, 3 times per week for 8 weeks, and the duration of physical activity per session is between 30 to 40 minutes based on the patient's ability.
Category
Rehabilitation

3

Description
Intervention group: sports activity on the uphill surface treadmill.The program for aerobic exercise in this study, using a treadmill on a uphill surface, 3 times per week for 8 weeks, and the duration of physical activity per session is between 30 to 40 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
7616913911
Phone
+98 34 3132 8000
Email
drryazdani@yahoo.com

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
a.alinaghi.langari@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Ahmad Alinaghi Langari
Position
Student
Latest degree
A Level or less
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
a.alinaghi.langari@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
article
When the data will become available and for how long
Get started since 1399
To whom data/document is available
For researchers at university institutes
Under which criteria data/document could be used
In order to facilitate future research
From where data/document is obtainable
dr yazdani
What processes are involved for a request to access data/document
Research Council Letter
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