Investigating the effect of telerehabilitation on amino acid metabolism
Design
A prospective pre-experimental design based on one group pre-test and post-test
Settings and conduct
Patients with COPD undergo regular online aerobic supervised exercises for eight weeks, three times a week, 60 minutes per session with moderate intensity. Serum levels of lysine and ornithine in arterial plasma and physical fitness parameters are measured before and after the intervention in each patient.
Participants/Inclusion and exclusion criteria
1. Men patients with COPD
2. Providing informed consent
3. Absence of special disease and recent surgery and hospitalization
Intervention groups
8-weeks aerobic and breathing exercises through online platforms
Main outcome variables
Serum levels of lysine and ornithine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201205049609N1
Registration date:2023-07-11, 1402/04/20
Registration timing:retrospective
Last update:2023-07-11, 1402/04/20
Update count:0
Registration date
2023-07-11, 1402/04/20
Registrant information
Name
Nazanin Shahabi Nezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3212 1282
Email address
n.shahabi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-01, 1400/10/11
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
2022-01-21, 1400/11/01
Actual recruitment end date
2022-06-20, 1401/03/30
Trial completion date
empty
Scientific title
Effect of online aerobic and breathing exercises on serum level of lysine and ornithine in Chronic Obstructive Pulmonary Disease Patients
Public title
Investigating the effect of online exercise training on the serum level of amino acids
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male COPD patients
Stable condition
Exclusion criteria:
Age
From 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Actual sample size reached:
24
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kerman University of Medical Sciences
Family history of asthma and other chronic lower respiratory diseases
Primary outcomes
1
Description
serum level of amino acid
Timepoint
Before and after 8 weeks of intervention
Method of measurement
high-performance liquid chromatography
Secondary outcomes
1
Description
Physical fitness parameters
Timepoint
Before and after 8 weeks of intervention
Method of measurement
fitness tests
Intervention groups
1
Description
Intervention group: male COPD patients Selected patients with Chronic Obstructive Pulmonary Disease (COPD) undergo regular online aerobic supervised exercises for eight weeks, three times a week, 60 minutes per session with moderate intensity. The exercise focuses on diaphragmatic strengthening breathing which is called “Diaphragmatic Breathing Exercise”. Serum levels of lysine and ornithine in arterial plasma, anthropometric parameters, and physical fitness parameters will analyze before and after the intervention in each patient. The amino acid concentrations are measured by ion-exchange, high-pressure liquid chromatography with fluorometric detection.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour hospital
Full name of responsible person
Rostam Yazdani
Street address
Imam Khomeini Highway, Next to the Shahid bahonar uni, Afzalipor medical education center, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
afzalih@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Rostam yazdani
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5829
Email
VCR@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
Rostam Yazdani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipur Medical Education Center, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
31328000
Email
drryazdani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Rostam Yazdani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipur Medical Education Center, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
31328000
Email
drryazdani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Rostam Yazdani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipur Medical Education Center, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
31328000
Email
drryazdani@yahoo.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