Protocol summary

Summary
aim: the aim of this study was to assess the Effect of Aeirobic Movement Exercise During Hemodialysis on Dialysis Efficacy in Patients Undergoing Dialysis with Bicarbonate Solution. Methods:The study population was included 50 adult patients(25 cases and 25 controls) who regularly and non-emergency underwent hemodialysis two or three times a week in the dialysis center of Imam Khomeini Hospital in Sari for 2 months in 2010.Inclusion criteria were acceptance of eligible patients to participate in the study, full consciousness, having a history of at least three months of regular hemodialysis and use of bicarbonate solution. Exclusion criteria included:blood coagulation during hemodialysis on dialysis filter, perform irregular movements, the frequent loss or change in blood pressure during repeated general movements and exercises,and angina. intervention in case group was aerobic movement exercise by range of motion joints continuously for 15 minutes. control group didn’t perform exercise movements. serum urea were measured and recorded initially,at the end of 4th week and 8th week of study. the adequacy of dialysis was analyzed and recorded using (Kt/v) formula. obtained data were compared between the two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138904084268N1
Registration date: 2011-05-23, 1390/03/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-05-23, 1390/03/02
Registrant information
Name
Rahele Mohseni
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1227 4750
Email address
nu.mohseni@gmail.com
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2010-05-02, 1389/02/12
Expected recruitment end date
2010-07-03, 1389/04/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the Effect of Aeirobic Movement Exercise During Hemodialysis on Dialysis Efficacy in Undergoing Dialysis Patients with Bicarbonate Solution
Public title
Way to improve the Dialysis Efficacy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: full consciousness, having a history of at least three months of regular hemodialysis and use of bicarbonate solution. Exclusion criteria:blood coagulation during hemodialysis on dialysis filter, perform irregular movements, the frequent loss or change in blood pressure during repeated general movements and exercises,and angina.
Age
From 18 years old to 76 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
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
Deputy of Mazandaran University of Medical Sciences
Street address
Research & Technology of Mazandaran university of medical sciences,Moallem Squre
City
Sari
Postal code
Approval date
2010-07-07, 1389/04/16
Ethics committee reference number
89/23

Health conditions studied

1

Description of health condition studied
hemodialysis patient
ICD-10 code
N18.0
ICD-10 code description
End-stage renal disease

Primary outcomes

1

Description
Dialysis Efficacy
Timepoint
Before the intervention, four weeks after the intervention, eight weeks after intervention
Method of measurement
Jnydal formul

Secondary outcomes

1

Description
Urea Reduction Ratio
Timepoint
Before the intervention, four weeks after the intervention, eight weeks after intervention
Method of measurement
Urea Reduction Ratio formul

Intervention groups

1

Description
Intervention group: Aerobic exercise movements to rotate the wrist following: 20 rpm clockwise rotating the wrist: the 20th round in the opposite clockwise up to the wrist up and down: up to 20 moves on the forearm of the arm Elbow joint: ankle twisting motion 20: 20 hours rotating counterclockwise around the ankles: 20th round in the opposite direction clock ankles up and down: 20 Motion
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Hemodialysis Department, Imam Khomeini Hospital in Sari
Full name of responsible person
rahele mohseni
Street address
School of Nursing Midwifery Nasibeh-Vesal street-Amir mazandarani street
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Mazandaran University of Medical Sciences
Full name of responsible person
dr.ahmad ali enayati
Street address
Square Moallem
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Rahele Mohseni
Position
MA
Other areas of specialty/work
Street address
School of Nursing Midwifery Nasibeh-Vesal street-Amir mazandarani street
City
Sari
Postal code
Phone
+98 912 448 9475
Fax
Email
nu.mohseni@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Rahele Mohseni
Position
MA
Other areas of specialty/work
Street address
School of Nursing Midwifery Nasibeh-Vesal street-Amir mazandarani street
City
Sari
Postal code
Phone
+98 912 448 9475
Fax
Email
nu.mohseni@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Rahele Mohseni
Position
MA
Other areas of specialty/work
Street address
School of Nursing Midwifery Nasibeh-Vesal street-Amir mazandarani street
City
Sari
Postal code
Phone
+98 912 448 9475
Fax
Email
nu.mohseni@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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