Investigating the effect of 12 weeks of resistance training on Klotho-mediated arterial stiffness in patients with chronic kidney disease.
Design
A clinical trial with a control group will be conducted in phase 3 on 32 people with chronic kidney disease. And the Simple randomization method will be used to assign subjects to two groups.
Settings and conduct
The primary tests including all the main outcomes will be taken at Imam Hossein Shahrood Hospital before the intervention and after 12 weeks of intervention. Also, , the intervention group will perform resistance training for 12 weeks at the club of Shahrood University of Technology.
Participants/Inclusion and exclusion criteria
In stage 3 to 5 of chronic kidney disease, it means that their blood creatinine is higher than 1.5. Their body mass index should be less than 40. Their blood pressure should be less than 18 out of 10. have the ability to perform movement. Not using immunosuppressive drugs. No smoking. Having hypothyroidism and hyperthyroidism. No history of heart attack or stroke. Don't be born with kidney disease. Lack of regular exercise.
Intervention groups
Intervention group: Resistance exercises in the present study will start 3 days a week with an intensity of 60% 1RM and 5% overload will be applied every 4 weeks. These exercises will be 10 movements and 10-15 repetitions, the exercises will be stationary circular and will have 3 to 5 minutes of rest between each round and 30 to 60 seconds of rest between each movement. Control group:During the intervention period, they will continue their normal life and will inform the researcher only if there is a change in the medications and daily activities.
Main outcome variables
Central arterial stiffness with Cardio-ankle vascular index. Peripheral arterial stiffness with ankle-brachial index. Blood plasma klotho levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240107060639N1
Registration date:2024-03-16, 1402/12/26
Registration timing:registered_while_recruiting
Last update:2024-03-16, 1402/12/26
Update count:0
Registration date
2024-03-16, 1402/12/26
Registrant information
Name
adel donyaei
Name of organization / entity
Shahrood University of Technology
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5900
Email address
adelldonyai@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-03, 1402/01/14
Expected recruitment end date
2024-04-12, 1403/01/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of 12 weeks of resistance training on Klotho-mediated arterial stiffness in subjects with chronic kidney disease
Public title
Effect of resistance training on Klotho and arterial stiffness in chronic kidney disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
In stage 3 to 5 of ckd disease, it means that their blood creatinine is higher than 1.5.
Body mass index should be less than 40
Systolic blood pressure should be less than 18 and diastole less than 10
Have the ability to perform movement
Exclusion criteria:
Use of immunosuppressive drugs
Smoking and tobacco use
Having hypothyroidism and hyperthyroidism
History of heart attack and stroke
Congenital kidney disease
Have regular physical activities
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects are classified based on kidney function (EGFR) and creatinine level in three levels 3, 4 and 5 and with the opinion of a specialist doctor and project collaborator. Therefore, to eliminate heterogeneity in the groups, they will be divided into two control and intervention groups by stratified randomization before randomization. The allocation of each subject from each category (4, 3 and 5) will be done in a simple random manner based on the table of random numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
The allocation of the subjects in the study groups is as follows: the eligible people will be randomly assigned to the intervention and control groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrood University of Technology
Street address
university Blvd
City
Shahrood
Province
Semnan
Postal code
3619995161
Approval date
2023-10-13, 1402/07/21
Ethics committee reference number
IR.SHAHROODUT.REC.1402.023
Health conditions studied
1
Description of health condition studied
Chronic kidney patients (CKD)
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
Primary outcomes
1
Description
Central arterial stiffness with Cardio-ankle vascular index (CAVI)
Timepoint
Before the start of the intervention (12 weeks of training) and 48 hours after the last training session
Method of measurement
Arterial stiffness was measured by oscillometric method using VaSera VS-2000 (Fukuda Denshi, Tokyo, Japan)
2
Description
Peripheral arterial stiffness with ankle-brachial index (ABI)
Timepoint
Before the start of the intervention (12 weeks of training) and 48 hours after the last training session
Method of measurement
ankle-brachial index was measured by oscillometric method using VaSera VS-2000 (Fukuda Denshi, Tokyo, Japan)
3
Description
Blood plasma klotho levels
Timepoint
Before the start of the intervention (12 weeks of training) and 48 hours after the last training session
Method of measurement
By ELISA method with biochemical kits
Secondary outcomes
1
Description
Maximum muscle strength (upper body and lower body)
Timepoint
Before the start of the intervention (12 weeks of training) and 48 hours after the last training session
Method of measurement
Using the maximum repetition method
2
Description
Product of calcium and phosphorus
Timepoint
Before the start of the intervention (12 weeks of training) and 48 hours after the last training session
Method of measurement
By ELISA method with biochemical kits
3
Description
Vitamin D levels
Timepoint
Before the start of the intervention (12 weeks of training) and 48 hours after the last training session
Method of measurement
By ELISA method with biochemical kits
4
Description
Serum creatinine
Timepoint
Before the start of the intervention (12 weeks of training) and 48 hours after the last training session
Method of measurement
By ELISA method with biochemical kits
Intervention groups
1
Description
Intervention group: The exercise group will perform resistance exercises three days a week, resistance exercises in the present study will start 3 days a week with an intensity of 60% 1RM and 5% overload will be applied every 4 weeks. These exercises will be 10 movements and 10-15 repetitions, the exercises will be stationary circular and will have 3 to 5 minutes of rest between each round and 30 to 60 seconds of rest between each movement. This protocol is designed based on ACSM 2018 edition and articles in this field. Sports activity should be done on non-dialysis days, and the total time of each session will be between 60 and 90 minutes, including 15 minutes of warming up and 10 minutes of cooling down. It should be noted that the intensity and duration of activity for these people is not certain and it is flexible considering the condition of the subject.
Category
Treatment - Other
2
Description
Control group:During the intervention period, they will continue their normal life and will inform the researcher only if there is a change in the medications and daily activities.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Shahroud Hospital
Full name of responsible person
Monireh Ameriyan
Street address
Iran_Semnan_Shahroud_ St . Imam Khomeini Street
City
Shahrood
Province
Semnan
Postal code
۳۶۱۶۹۵۱۸۳۵
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
amerian1060@yahoo.com
Web page address
https://shmu.ac.ir/emh/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Hamid hasanpoor
Street address
University Blvd
City
Shahrood
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Fax
+98 23 3239 2209
Email
International@Shahroodut.ac.ir
Web page address
https://shahroodut.ac.ir/fa/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrood University of Technology
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
Shahrood University of Technology
Full name of responsible person
Adel donyaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
فیزیولوژی ورزشی
Street address
University blvd
City
Shahrood
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 5900
Fax
+98 23 3239 5900
Email
Adelldonyai@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Adel Donyaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
, NO. 180, West kaj Ave., kaj8., Shahrood
City
Shahrood
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 5900
Fax
+98 23 3239 5900
Email
adelldonyai@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Adel Donyaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
, NO. 180, West kaj Ave., kaj8., Shahrood
City
Shahrood
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 5900
Fax
+98 23 3239 5900
Email
adelldonyai@yahoo.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 subjects' data will be shared after de-identification.
When the data will become available and for how long
After the initial publication of the article
To whom data/document is available
For researchers working in academic institutions
Under which criteria data/document could be used
Only descriptive reports of data will be permitted.
From where data/document is obtainable
Please refer to the email of the person responsible for the scientific response of the study, Mr. Adel Donyaei, as follows:
Adelldonyai@yahoo.com
adonyai@shahroodut.ac
Or call 098-2332395900.
What processes are involved for a request to access data/document
State the reason for accessing the information and specify that you are an academic expert. In this way, the person can have access to the requested information after the correspondence and introducing himself and presenting the organizational affiliation if the information is confirmed.