Determining the effect of a wrist exercise program on the maturation of arteriovenous fistula in hemodialysis patients
Design
A controlled, parallel-group, unblinded, randomized, phase 3 clinical trial on 116 patients. For randomization, the block randomization method using blocks of 4 was used.
Settings and conduct
A randomized clinical trial study that will be conducted on dialysis patients in Arak city. After entering the study, patients will be randomly divided into intervention and control groups. The results will be analyzed after 3 months of intervention. Blinding was not done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Patients who have undergone hemodialysis and have undergone Arteriovenous fistula (AVF) surgery, over 18 years of age, should undergo dialysis at least 2 times a week. Exclusion criteria: suffering from other chronic diseases.
Intervention groups
In the intervention group, 58 patients do an exercise program at home using a CD. Wrist exercises will be performed in the hand without fistula of patients using light weight and stretching and softening movements. One-hour sports classes will be held at home twice a week for 1 months. Under the supervision of a resident in charge of the eligible plan, patients will perform the relevant exercise programs. A typical class consisted of a 5 to 10 minute warm-up period, 20 to 30 minutes of preparatory exercises, and a 5 to 10 minute cool-down period. In the control group, 58 patients will be monitored for 3 months without performing wrist sports.
Main outcome variables
Clinical maturity of fistula, Ultrasonographic maturity of fistula
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210224050491N2
Registration date:2023-03-23, 1402/01/03
Registration timing:prospective
Last update:2023-03-23, 1402/01/03
Update count:0
Registration date
2023-03-23, 1402/01/03
Registrant information
Name
ghasem mehri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3630
Email address
ghasemmehri1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-05-21, 1402/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of a wrist exercise program on the maturation of arteriovenous fistula and Steele's syndrome in hemodialysis patients
Public title
The effect of a wrist exercise program on the maturation of arteriovenous fistula
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have undergone hemodialysis and Arteriovenous fistula surgery
Dialyses at least 2 times a week
Age above 18 years
Exclusion criteria:
Suffering from other chronic diseases
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
116 patients are randomly placed in two groups A and B using block randomization method (block of four). Due to having two intervention and control groups in each block, an equal number of states A and B should be placed, and due to the volume of four blocks, there were six different states for the blocks, which are: AABB, ABAB, ABBA BBAA , BABA, BAAB. The different states of the blocks will be written on cardboard cards of the same size and color. Then the obtained sequences are placed in sealed envelopes and the number of 29 cards is randomly selected and arranged again by replacing the blocks, the order of placement of patients in groups A (intervention) and B (control) will specify.
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 Arak University of Medical Sciences
Street address
Payambar azam complex, Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2022-12-11, 1401/09/20
Ethics committee reference number
IR.ARAKMU.REC.1401.265
Health conditions studied
1
Description of health condition studied
Arteriovenous fistula
ICD-10 code
I77.0
ICD-10 code description
Arteriovenous fistula, acquired
Primary outcomes
1
Description
Clinical maturation of arteriovenous fistula
Timepoint
One month after the start of the intervention
Method of measurement
Physical examination
2
Description
Ultrasonographic maturation of arteriovenous fistula
Timepoint
One month after the start of the intervention
Method of measurement
Examination of ultrasound indicators by a radiologist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, 58 patients do an exercise program at home using a CD. Wrist exercises will be performed in the hand without fistula of patients using light weight and stretching and softening movements. One-hour sports classes will be held at home twice a week for 1 month. Under the supervision of a resident in charge of the eligible plan, patients will perform the relevant exercise programs. A typical class consisted of a 5- to 10-minute warm-up period, 20 to 30 minutes of preparatory exercises, and a 5- to 10-minute cool-down period.
Category
Rehabilitation
2
Description
Control group: In the control group, 58 patients will be monitored for 1 month without performing wrist sports.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir-al-momenin hospital
Full name of responsible person
Hamed Motahari
Street address
Payambar azam complex, Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3619
Email
it-amiralmomenin@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahdi Salehi
Street address
Payambar azam complex, Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 6341
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Hamed Motahari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Payambar azam complex, Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 6341
Email
Dr.motahari1963@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hamed Motahari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Payambar azam complex, Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 6341
Email
Dr.motahari1963@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hamed Motahari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Payambar azam complex, Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 6341
Email
Dr.motahari1963@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