Protocol summary

Study aim
Determination of the effect of small bicycle exercise on tiredness, sexual function and dialysis adequacy in hemodilysis patients
Design
Clinical trial study with control group with parallel, randomized, non-blinded groups
Settings and conduct
Study setting: hemodialysis centers affiliated with Kerman University of Medical Sciences including dialysis department of Shafa hospital and dialysis center of Javad Alameh. How to do the study: Patients are divided into two groups of intervention and control. The intervention group will exercise for 20 minutes. Sexual function and fatigue questionnaire are completed by them. The control group does not receive intervention and only completes the questionnaire of sexual function and fatigue. This work is done for 3 months.
Participants/Inclusion and exclusion criteria
"Inclusion" At least 3 months have elapsed since the start of their dialysis, Hemodialysis is performed twice a week and for 4 hours, The spouse is still alive, People between 18 and 76 years old; "Exclusion" Parathyroid hormone above 1000, Diabetic wound in the legs, The spouse's death, Divorce
Intervention groups
Intervention group: Patients undergoing hemodialysis exercise with small bicycles during dialysis for 3 months, twice a week and 20 minutes. Control group: Patients undergoing hemodialysis do not receive an intervention and routine care is provided to them.
Main outcome variables
Sexual function, Fatigue, Adequacy of dialysis

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180314039100N1
Registration date: 2018-10-06, 1397/07/14
Registration timing: retrospective

Last update: 2018-10-06, 1397/07/14
Update count: 0
Registration date
2018-10-06, 1397/07/14
Registrant information
Name
Farzaneh Salehi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 5813
Email address
farzaneh.salehi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-31, 1397/03/10
Expected recruitment end date
2018-09-01, 1397/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of exercise with mini bike on fatigue, sexual function and dialysis adequacy in Hemodialysis patients
Public title
Effect of exercise with mini bike on Hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least 3 months have elapsed since the start of their dialysis Hemodialysis is performed twice a week and for 4 hours The spouse is still alive People between 18 to 76 years old
Exclusion criteria:
Parathyroid hormone above 1000 Diabetic wound in the legs Prohibition on exercising The spouse's death Divorce Remarriage People with heart disease Orthopedic problems in the lower extremities
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: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients are selected by census method and then, according to the entry conditions, they are randomly assigned to the intervention and control groups by lottery. Draw coins are used. So that each coin is thrown. Patients who have shape for them are in the intervention group and for those who come to the line they are in the control group. Both groups will be matched in terms of age and gender.
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 Kerman University of Medical Sciences
Street address
Shafa hospital, end of Shafa street, Jomhuri boulevard
City
Kerman
Province
Kerman
Postal code
7618751151
Approval date
2018-06-12, 1397/03/22
Ethics committee reference number
IR.KMU.REC.1397.086

Health conditions studied

1

Description of health condition studied
Chronic renal failure
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease

Primary outcomes

1

Description
The score of exercise with minibike
Timepoint
Before the intervention, one month after the intervention, two months after the intervention, three months after the intervention, one month after the end of the intervention
Method of measurement
Fatigue Questionnaire, Sexual Function and Dialysis Sufficiency

Secondary outcomes

1

Description
Sexual function
Timepoint
Before starting study and then every month during 3 months and 1 month after finishing study
Method of measurement
Sexual Function Questionnaire

2

Description
Fatigue
Timepoint
Before starting study and then every month during 3 months and 1 month after finishing study
Method of measurement
Fatigue questionnaire

3

Description
Adequacy of dialysis
Timepoint
Before starting study and then every month during 3 months and 1 month after finishing study
Method of measurement
The software calculates the adequacy of dialysis (kt/v)

Intervention groups

1

Description
Intervention group: Intervention will be using a small bicycle. In this research, bikes will be used with electric power for easy pedaling. The bicycle is placed on the bed immediately and connected to the dialysis device immediately after attaching the patient. The timer is set to 20 minutes and the key is started. Before starting exercise, the patient's blood pressure will be measured to determine the clinical condition. The Exercises with a small bike will be done twice a week and at the beginning of dialysis for 20 minutes. It will be continue for 12 weeks.
Category
Rehabilitation

2

Description
Control group: There is no intervention in the control group and they will receive routine care as usual.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
DR. Parvin Mangolian
Street address
Shafa hospital, end of Shafa street, Jomhuri Boulevard
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5811
Fax
+98 34 3211 5803
Email
mangolian167@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Kerman University of Medical Sciences, Medical University Compus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3855
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
Farzaneh Salehi
Position
MSc student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shafa hospital, end of the Shafa street, Jomhori boulvard
City
Kerman
Province
Kerman
Postal code
7617894593
Phone
+98 34 3211 5813
Email
farzaneh.salehi3@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Farzaneh salehi
Position
MSc student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shafa hospital, end of shafa street, Jomhori Boulvard
City
Kerman
Province
Kerman
Postal code
7617894593
Phone
+98 34 3211 5813
Email
farzanehsalehi3@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Farzaneh Salehi
Position
MSc student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shafa hospital, end of shafa street, Jomhori Boulvard
City
Kerman
Province
Kerman
Postal code
7617894593
Phone
+98 34 3211 5813
Email
farzanehsalehi3@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Unidentifiable data from individuals and related information will be shared with other researchers Study protocol, data analysis program, etc, will be shared
When the data will become available and for how long
Access to data is always available.
To whom data/document is available
All researchers are allowed to use.
Under which criteria data/document could be used
Data can be used for research on variables and the provision of new solutions with the mention of the reference.
From where data/document is obtainable
See the email of the researcher or the journal in which the article has been published
What processes are involved for a request to access data/document
Search in the Internet by using keywords and selecting titles or requesting them by sending an email to the researcher
Comments
Loading...