Evaluation of aerobic exercise effect on serum level and ratio of Apolipoprotein A1 to Apolipoprotein B in patients with chronic obstructive pulmonary disease
To determine the effect of aerobic exercise on serum levels of apolipoprotein A1 and B and their ratio in patients with chronic obstructive pulmonary disease
Design
In this study, a pre-test and post-test design, 22 men with COPD were randomly assigned to aerobic exercise and control groups.
Settings and conduct
This study was not blinded. It was done on the COPD patients of kerman province.The aerobic exercise program was performed for two months and three sessions per week and each session was 30 to 40 minutes. Serum levels were measured and evaluated before and after aerobic exercises
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 40 to 70,,, BMI 19 to 24
Exclusion criteria: cardiovascular and musculoskeletal disease
Intervention groups
We programmed aerobic exercise for 2 months,, 3 sessions weekly for intervention group
We had no excees work for control group
Main outcome variables
Serum levels of apolipoprotein A1 and apolipoprotein B and the ratio of apo A1 to Apo B were measured and evaluated before and after aerobic exercises in both groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171224038032N1
Registration date:2018-11-04, 1397/08/13
Registration timing:retrospective
Last update:2018-11-04, 1397/08/13
Update count:0
Registration date
2018-11-04, 1397/08/13
Registrant information
Name
Samira Nakhaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3281 1515
Email address
samira.nakhaie@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-08-25, 1395/06/04
Expected recruitment end date
2017-02-25, 1395/12/07
Actual recruitment start date
2016-08-25, 1395/06/04
Actual recruitment end date
2017-06-20, 1396/03/30
Trial completion date
2017-08-21, 1396/05/30
Scientific title
Evaluation of aerobic exercise effect on serum level and ratio of Apolipoprotein A1 to Apolipoprotein B in patients with chronic obstructive pulmonary disease
Public title
Aerobic exercise effect on serum level and ratio of Apolipoprotein A1 to Apolipoprotein B in patients with chronic obstructive pulmonary disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 40 to 70
Body mass index 19 to 24
Exclusion criteria:
Cardiovascular disease
Musculoskeletal disease
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
More than 1 sample in each individual
Number of samples in each individual:
2
Apolipoprotein A1 and B
Actual sample size reached:
22
More than 1 sample in each individual
Actual sample size in each individual:
44
Apolipoprotein A1 and B
Randomization (investigator's opinion)
Randomized
Randomization description
Simple 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 Kerman University of Medical Science
Street address
Somaye street
City
Kerman
Province
Kerman
Postal code
۱۲۳۴۵۶۷۸۹۰
Approval date
2016-08-15, 1395/05/25
Ethics committee reference number
IR.KMU.REC.1395.677
Health conditions studied
1
Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
J44
ICD-10 code description
Other specified chronic obstructive pulmonary disease
Primary outcomes
1
Description
Serum level of Apolipoprotein A1
Timepoint
Before and 2 months after intervention
Method of measurement
Lab kit
Secondary outcomes
1
Description
Apolipoprotein B
Timepoint
Before and 2 months after intervention
Method of measurement
Lab kit
Intervention groups
1
Description
"Intervention group:" 11 men with COPD assigned to this group.The aerobic exercise program was performed for two months and three sessions per week and each session was 30 to 40 minutes; Blood samples for measuring serum level of apolipoprotein A1 and apolipoprotein B were taken before and after two months.
Category
Rehabilitation
2
Description
"Control group:" 11 men with COPD assigned to this group and they received nothing. Blood samples for measuring serum level of apolipoprotein A1 and apolipoprotein B were taken before and after two months.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipoor hospital
Full name of responsible person
Rostam Yazdani
Street address
Emam Khomeini highway
City
Kerman
Province
Kerman
Postal code
1234567890
Phone
+98 34 3222 2250
Email
dryazdani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr Ali Asadi
Street address
Somaye St
City
Kerman
Province
Kerman
Postal code
1234567890
Phone
+98 34 3121 5915
Fax
Email
aliasadipour@kmu.ac.ir
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
Samira Nakhaei
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Havanirooz blvd
City
Kerman
Province
Kerman
Postal code
1234567890
Phone
+98 83432811515
Email
Samira.nakhaie@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Samira Nakhaei
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Havanirooz Blvd
City
Kerman
Province
Kerman
Postal code
1234567890
Phone
+98 34 3281 1515
Email
Samira.nakhaie@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Samira Nakhaei
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Havanirooz Blvd
City
Kerman
Province
Kerman
Postal code
1234567890
Phone
+98 34 3281 1515
Email
Samira.nakhaie@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
All data
When the data will become available and for how long
3 months after publication
To whom data/document is available
مراکز آکادمیک
Under which criteria data/document could be used
Ethics committe agreement
From where data/document is obtainable
Email address; phone number
What processes are involved for a request to access data/document