The purpose of this study was to determine the effect of Rehabilitation program on fatigue and quality of sleep in Hemodialysis patients
Design
In this research, 50 eligible patients referring to Imam sajjad Hospital were chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups
Settings and conduct
Due to easy access to samples, this study will be carried out at Imam Sajjad hospital of shahriar. Samples were selected by available method and randomly divided into two groups of intervention and control. Before and one month after the intervention, the multidimensional fatigue questionnaire MF1-20 and Pittsburgh quality of sleep will be completed in both groups. Data collected by SPSS software and statistical tests will be analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Consent to participate in research and having cooperation; not participated in previous rehabilitation program in Last three months; Ability to communicate effectively with researcher; ability to handle meetings and prepared to respond to questions physically and mentally; Minimum 18 and maximum 80 years old; having the ability to read and write; Have a history of hemodialysis for at least 6 months. Exclusion criteria: withdrawal to continue cooperation; being in the recurrence of the disease and inability to attend in the meetings; Patient death.
Intervention groups
Control group: : The control group receive routine care.
For the intervention group, Rehabilitation program is implement including: 1. Daily Activity Training 2. Walk 3. Perform foot massage during hemodialysis. In intervention group, Rehabilitation sessions will be performed in 12 sessions of 10 Minutes, two session a week.
Main outcome variables
fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171213037863N1
Registration date:2017-12-29, 1396/10/08
Registration timing:retrospective
Last update:2017-12-29, 1396/10/08
Update count:0
Registration date
2017-12-29, 1396/10/08
Registrant information
Name
marzieh shayani momtaz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0036
Email address
ma.shayani@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-01, 1396/05/10
Expected recruitment end date
2017-12-06, 1396/09/15
Actual recruitment start date
2017-08-01, 1396/05/10
Actual recruitment end date
2017-12-06, 1396/09/15
Trial completion date
empty
Scientific title
The Effect of Rehabilitation Program on Fatigue and Quality of Sleep in hemodialysis Patients
Public title
The Effect of Rehabilitation Program on Fatigue and Quality of Sleep
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in research and having cooperation
not participated in previous rehabilitation program in Last three months
Ability to communicate effectively with researcher; ability to handle meetings and prepared to respond to questions physically and mentally
Minimum 18 and maximum 80 years old
having the ability to read and write
Have a history of hemodialysis for at least 6 months
Exclusion criteria:
withdrawal to continue cooperation
being in the recurrence of the disease and inability to attend in the meetings
Patient death
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Table of random numbers was used For randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Table of random numbers will be used For randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Social welfare and Rehabilitation Sciences
Street address
Koodakyar Avenue, Daneshjoo Blvd, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2017-10-18, 1396/07/26
Ethics committee reference number
IR.USWR.REC.1396.173
Health conditions studied
1
Description of health condition studied
Patients who are treated with hemodialysis
ICD-10 code
Renal Fail
ICD-10 code description
N18.5
Primary outcomes
1
Description
Fatigue
Timepoint
Before and one month after the intervention
Method of measurement
multidimensional fatigue inventory
2
Description
quality of Sleep
Timepoint
Before and one month after the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, Rehabilitation program is implement including: 1. Daily Activity Training 2. Walk 3. Perform foot massage during hemodialysis. In intervention group, Rehabilitation sessions will be performed in 12 sessions of 10 Minutes, two session a week.Control group: : The control group receive routine care.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Sajjad Hospital
Full name of responsible person
Marzieh Shayani Momtaz
Street address
Tehran Province, Shahriar, Nabovvat Alley, Vali-e Asr St
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 6522 6041
Email
ma.shayani@uswr.ac.ir
Web page address
http://hospes.iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr. Hamidreza khankeh
Street address
Koodakyar Avenue, Daneshjoo Blvd, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0036
Email
ma.shayani@uswr.ac.ir
Web page address
http://www.uswr.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Marzieh Shayani Momtaz
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Koodakyar Avenue, Daneshjoo Blvd, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0036
Email
ma.shayani@uswr.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Dr. narges Arsalani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Koodakyar Avenue, Daneshjoo Blvd, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0036
Email
nargesarsalani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Marzieh Shayani momtaz
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Koodakyar Avenue, Daneshjoo Blvd, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0036
Email
ma.shayani@uswr.ac.ir
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