The efect of an educational program based on the teach back method on physical function and quality of life in hemodialysis pationts referred to Hamadan haspitals.
Design
This is a Randomised clinical trial study that patients will be randomly assigned to control and intervention based on block randomization. 90 patients will participate in this study.
Settings and conduct
The research community are the patients with kidney failure under the hemodyalisis in the Beheshti and Besat hospitals in Hamedan city. At the pre - test stage, both groups will complete the demographic questionnaire, the questionnaire related to the quality of life of patients with renal disease (KDQOL SF) will be filled. It will also be recorded by the researcher for the length of a period of 6 minutes walking. The training of sports is given orally to the patient, and then we ask the patient to repeat the content of exercise to us if a wrong understanding is noticed, the patient will be trained again. The physical activity and quality of life in patients, lives in both groups will be measured at the end of the first week, 2nd, 4th, 6th, 8th, 10th and 12th.
Participants/Inclusion and exclusion criteria
Having satisfaction to participate in the study, performing a hemodialysis treatment for at least 6 months, having no cardiovascular disease that prevents the exercise program; not participating in the exercise program for 4 times during the entire test program, leaving the dialysis due to the transplant Kidney or any other action, dissatisfaction to continue cooperation.
Intervention groups
The intervention group will perform in 3 sessions of lower limb booster exercises with isotonic and isometric exercises designed by a sports medicine specialist within a week, and no action was taken in the control group and received routine care.
Main outcome variables
Physical function; Quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170130032303N5
Registration date:2019-02-14, 1397/11/25
Registration timing:registered_while_recruiting
Last update:2019-02-14, 1397/11/25
Update count:0
Registration date
2019-02-14, 1397/11/25
Registrant information
Name
Morteza Shamsizadeh
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0535
Email address
shamsizadeh@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efect of an educational program based on the teach back method on physical function and quality of life in hemodialysis pationts
Public title
The efect of an educational program on physical function and quality of life in hemodialysis pationts
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to read and write
Have satisfaction for the company in the study
Under hemodyalisis at least 6 monthes
Lack of hospital history in the last six months
Do not do regular exercise programme in the last six months
Do not have a special orthopaedic problem preventing a walk
Do not have Cardiovascular disease, asthma, acute heart failure to prevent a sports programme
Exclusion criteria:
Non - participating in the sport program for 4 times during the entire test program
Dispensing the continuation of the exercise program
Leave dialysis due to kidney transplant or any other action
Patients death
Lack of satisfaction with continuing co - operation
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation with block Randomization
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
Hamedan University of Medical Sciences
Street address
Mahdieh street
City
hamedan
Province
Hamadan
Postal code
65178
Approval date
2019-01-05, 1397/10/15
Ethics committee reference number
IR.UMSHA.REC.1397.734
Health conditions studied
1
Description of health condition studied
Chronic Kidney Disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Physical Function
Timepoint
Before the intervention begins, the end of the first week, the second, the fourth, the eighth, the tenth, the tenth and the twelfth.
Method of measurement
Six-Minute Walk Test
2
Description
Quality Of Life
Timepoint
Before the intervention begins, the end of the first week, the second, the fourth, the eighth, the tenth, the tenth and the twelfth.
Method of measurement
Kidney Disease Quality of Life Short Form (KDQOL-SF™)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The intervention group will perform during the following week, along with isotonic and isometric exercise, which are designed by a sports expert
Category
Other
2
Description
Control group: no action was carried out and routine health care was received.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Faezeh Ranjbaran
Street address
Shahidbeheshti Blvd
City
Hamedan
Province
Hamadan
Postal code
65178
Phone
+98 81 3264 0020
Fax
+98 81 3262 1515
Email
besat@umsha.ac.ir
Web page address
http://besat.umsha.ac.ir/.
2
Recruitment center
Name of recruitment center
Shahid Beheshti Medical Educational Center
Full name of responsible person
Faezeh Ranjbaran
Street address
Eram Blvd
City
Hamedan
Province
Hamadan
Postal code
3371-5-65179
Phone
+98 81 3838 0283
Fax
+98 81 3838 1035
Email
Shahidbeheshti@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Manochehr karamy
Street address
Shahidfahmideh Avn
City
Hamedan
Province
Hamadan
Postal code
65178
Phone
+98 81 3252 0683
Email
ICT@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Faezeh Ranjbaran
Position
Nursing Student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
No.300, Reyhani Allay, Jafari Avn, Mahdieh Str
City
Hamedan
Province
Hamadan
Postal code
6518011111
Phone
+98 81 3838 9902
Email
fa.ranjbaran.ezeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Faezeh Ranjbaran
Position
Nursing Student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
No.300, Reyhani Allay, Jafari Avn, Mahdieh Str
City
Hamedan
Province
Hamadan
Postal code
6518011111
Phone
+98 81 3838 9902
Email
Fa.ranjbaran.ezeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Faezeh Ranjbaran
Position
Nursing Student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
No.300, Reyhani Allay, Jafari Avn, Mahdieh Str
City
Hamedan
Province
Hamadan
Postal code
6518011111
Phone
+98 81 3838 9902
Email
fa.ranjbaran.ezeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD