Determine the effect of exercise on serum BDNF in patients with COPD in Kerman, Iran
Design
Parallel group, randomized controlled trial without blinding. 30 patients with COPD will be divided randomly in two groups: control and aerobic exercise
Settings and conduct
The study will be conducted in pulmonary ward, Afzalipour hospital. 30 patients will be selected as sample with convenience sampling and then will be divided in 2 groups randomly. The serum level of BDNF will be measured and compared between groups.
Participants/Inclusion and exclusion criteria
People with COPD ages 40 to 70 years and with body mass index of 19 to 24 with out other medical problems: heart disease (including recent myocardial infarction, myocardial ischemia, cardiac erythema), chronic liver, kidney, gastrointestinal, musculoskeletal, and central nervous system disease. Patients who have a resting dose of Sao2 (less than 88% of the saturated blood of o2) and are not modified by hypoxic oxygenation are excluded.
Intervention groups
The control group received routine care and the procedure was followed by telephone calls once a week for a maximum of 10 minutes.
The intervention group, in addition to the usual care, participated in the lung rehab program. The aerial rehabilitation program in this study was performed on bicycles three times a week for 4 weeks.
Main outcome variables
Changes in serum level of BDNF
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171216037904N1
Registration date:2019-03-31, 1398/01/11
Registration timing:retrospective
Last update:2019-03-31, 1398/01/11
Update count:0
Registration date
2019-03-31, 1398/01/11
Registrant information
Name
elahe barkhordari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4423 2724
Email address
elahebarkhordari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-20, 1397/01/31
Expected recruitment end date
2018-07-22, 1397/04/31
Actual recruitment start date
2018-04-20, 1397/01/31
Actual recruitment end date
2018-07-22, 1397/04/31
Trial completion date
2018-07-22, 1397/04/31
Scientific title
The Evaluation effect of aerobic exercise on serum BDNF in patients with COPD in kerman
Public title
The effect of aerobic exercise on serum BDNF levels in patients with COPD
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People who have 5 years of history of the disease
Age 40 to 70 years
Body mass index 19 to 24
Their severity is mild to moderate
Exclusion criteria:
Patients with heart disease (including recent myocardial infarction, myocardial ischemia, cardiac erythema), chronic liver, kidney, gastrointestinal, musculoskeletal, and central nervous system were excluded.
Age
From 40 years old to 70 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
22
Actual sample size reached:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Twenty-two patients were selected by simple sampling method and were randomly assigned to two groups of eleven people after being consciously informed consent.
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
Ebne-sina St. Research deputy, Kerman University of Medical Sciences
Out of all subjects in two stages, pre-test and post-test after the month of blood sampling, fasting at 5 AM was performed in the post-test phase four days after the last training session.
Method of measurement
Blood samples were collected from a 2-secreted blood sample of the antiviral antagonists of EDTA, and after 12 minutes centrifugation with 3000 doses of serum, BDNF levels were measured by ELISA method by kit.
Secondary outcomes
1
Description
serume level of BDNF
Timepoint
Before and two months after intervention
Method of measurement
Test kit
Intervention groups
1
Description
The intervention group: Eleven men with COPD in this group were scheduled to undergo aerobic exercise for two months, three sessions per week and for thirty to forty minutes each session. Blood samples were taken to measure serum BDNF levels before And then the two month period was taken.
Category
Rehabilitation
2
Description
Control group: Eleven men with COPD were in this group, and no additional action was taken during the two months. Blood samples were taken to measure serum BDNF levels before and after the 2-month period
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour hospital
Full name of responsible person
Elaheh Barkhordari
Street address
Afzalipour hospital, Imam Khomeini Highway
City
Kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3132 8000
Fax
+98 34 3132 8000
Email
Elahebarkhordari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Abass Pardakhty
Street address
Ebne-sina St. Research deputy of Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3719
Fax
+98 34 3226 3857
Email
abpardakhty@kmu.ac.ir
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
Elaheh Barkhordari
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Afzalipour hospital, Imam Khomeini Highway
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Email
Elahebarkhordari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Elaheh Barkhordari
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Afzalipour hospital, Imam Khomeini Highway
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Email
Elahebarkhordari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Elahe Barkhordari
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Afzalipour hospital, Imam khomeini Highway
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 4423 2724
Fax
Email
elahebarkhordari@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available