Protocol summary

Study aim
Effects of physical practice on Quality of life, physical activity & power of judge in hemodialyses patients
Design
This study is clinical trial and double blind.45 patients undergoing hemodialysis in Valiasr Hospital are enrolled.30 patients in the exercise group and 15 patients in the control group.
Settings and conduct
This study is clinical trial and double blind.45 patients undergoing hemodialysis in Valiasr Hospital are enrolled.The analyzer and outcome reviewer is not aware of the treatment received.this study is double blind.
Participants/Inclusion and exclusion criteria
Effects of physical practice on Quality of life, physical activity & power of judge in hemodialyses patients
Intervention groups
We will divide patients in 2 groups(exercise and control).We is performed exercise 3 times a week according to the schedule of dialysis days, and preferably in the first 2 hours of hemodialysis in intervention group.There is no exercise program in the control group.
Main outcome variables
Quality of life, evaluation of muscle strength

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141209020258N78
Registration date: 2018-05-31, 1397/03/10
Registration timing: retrospective

Last update: 2018-05-31, 1397/03/10
Update count: 0
Registration date
2018-05-31, 1397/03/10
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-11-19, 1393/08/28
Expected recruitment end date
2016-11-18, 1395/08/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of physical practice on Quality of life, physical activity & power of judge in hemodialyses patients
Public title
Effects of physical practice on Quality of life, physical activity & power of judge in hemodialyses patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
18-60 years There is no myocardial infarction in the last 1 month Lack of visual impairment or hearing loss Do not use drugs that cause cognitive impairment, such as chemotherapy drugs
Exclusion criteria:
A member's amputation is a condition in which the patient is not able to use a fixed bike Perform less than 70% of the exercise program. Uncontrolled diabetes pregnant women CVA recent
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization with use random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
ََAnalyzer and outcome reviewer is not aware of the treatment received.this study is double blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Approval date
2016-11-18, 1395/08/28
Ethics committee reference number
93-168-1

Health conditions studied

1

Description of health condition studied
Hemodialysis
ICD-10 code
R88.0
ICD-10 code description
Cloudy (hemodialysis) (peritoneal) dialysis effluent

Primary outcomes

1

Description
Quality of life
Timepoint
Before exercise, third and sixth months
Method of measurement
Quality of Life Questionnaire

2

Description
Evaluation of muscle strength
Timepoint
Before the beginning of the exercise program, 12 week and 24 week exercise program
Method of measurement
sports test sit and stand 30 second

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: We is performed exercise 3 times a week according to the schedule of dialysis days, and preferably in the first 2 hours of hemodialysis in intervention group.
Category
Treatment - Other

2

Description
Control group: There is no exercise program in the control group.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Parvin Sultani
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
soltani.parvin@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Arjmandzadegan
Street address
Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
38149578558
Phone
+98 86 3417 3638
Fax
+98 86 3222 2003
Email
arjmandzadegan@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
Dr Leila Poursaadat
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
38149578558
Phone
+98 86 3417 3638
Email
Porsaadat@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Parvin Sultani
Position
Assisstant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
38149578558
Phone
+98 86 3417 3638
Email
soltani.parvin@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Parvin Sultani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
38149578558
Phone
+98 86 3222 2003
Email
soltani.parvin@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
When we publish article in journal
When the data will become available and for how long
After the article is published
To whom data/document is available
researcher in university
Under which criteria data/document could be used
If there are additional questions
From where data/document is obtainable
Dr Parvin Sultani
What processes are involved for a request to access data/document
They have to write letters to the professors and the university.
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