Evaluation of the Effectiveness of Physical Activity During Dialysis on the Dialysis Adequacy, Hemodynamic Indices and Fatigue in Hemodialysis Patients
Evaluation of the effectiveness of physical activity during dialysis on dialysis adequacy, hemodynamic parameters and fatigue in hemodialysis patients
Design
A randomized, controlled, single blind, with parallel groups clinical trial
Settings and conduct
The place of study: Bushehr hospitals.
This is a single blind study in which performers of paraclinical tests, the person who enters data into software, and the person who analyzes data will be kept unaware of the intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years old;
History of dialysis more than 3 months;
Ability to perform walking independently (at least 2 minutes);
4-hour dialysis tolerance in past sessions
Non inclusion criteria:
The history of unstable angina and heart attack in the past month;
History of congestive heart failure;
Treatment with psychiatric drugs;
History of hypokalemia (K<3.5Meq/L)
Intervention groups
Intervention group: Patients undergoing hemodialysis treatment who do physical activity for half an hour during dialysis and in the first two hours of dialysis using a pedal that is installed at the bottom of the bed.
Control group: Patients undergoing hemodialysis treatment who received routine four-hour hemodialysis.
Main outcome variables
Dialysis adequacy, fatigue, blood pressure, pulse, respiration, temperature and O2 saturation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150529022466N15
Registration date:2020-05-05, 1399/02/16
Registration timing:retrospective
Last update:2020-05-05, 1399/02/16
Update count:0
Registration date
2020-05-05, 1399/02/16
Registrant information
Name
Shahnaz Pouladi
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 374 0061
Email address
sh.pooladi@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effectiveness of Physical Activity During Dialysis on the Dialysis Adequacy, Hemodynamic Indices and Fatigue in Hemodialysis Patients
Public title
The effect of physical activity during dialysis on dialysis adequacy, hemodynamic indicators and fatigue in patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years old
History of hemodialysis more than 3 months
Ability to perform walking independently (at least 2 minutes)
4-hour dialysis tolerance in past sessions
No history of hypokalemia (K<3.5 Meq/L)
Exclusion criteria:
Having problems with the musculoskeletal system
Systolic blood pressure greater than or equal to 160 mmHg or diastolic blood pressure greater than or equal to 120 mmHg
Having vascular access in the lower extremities
History of unstable angina and heart attack in 1 last month
History of congestive heart failure
Treatment with psychotropic drugs
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting all available participants based on inclusion criteria, randomization will be done using simple randomization method and statistical software.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the study, each participant will have a code that only the researcher will have access to, and the participant's name will not be specified for the outcomes evaluator and data analyzer. Paraclinical tests performance, record data and enter data into the software for analysis using code and without revealing the study group and name.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Bushehr University of Medical Sciences
Street address
Sabzabad Ave.
City
Bushehr
Province
Boushehr
Postal code
7518759577
Approval date
2019-12-22, 1398/10/01
Ethics committee reference number
IR.BPUMS.REC.1398.130
Health conditions studied
1
Description of health condition studied
End Stage Renal Disease (ESRD), Hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Dialysis adequacy which is assessed by measuring the blood urea nitrogen levels before and after dialysis, the amount of fluid excreted from the patient and the weight after dialysis.
Timepoint
It is measured before the start of the study and after each dialysis session. Then the average is estimated at the end of the one month study period.
Method of measurement
Dialysis adequacy calculation software and Kt / V
2
Description
Fatigue
Timepoint
Before and after the one month study period
Method of measurement
FSS questionnaire
3
Description
blood pressure
Timepoint
Before and after dialysis and at each dialysis session until the end of the study period
Method of measurement
Using a digital device
4
Description
pulse
Timepoint
Before and after dialysis and at each dialysis session until the end of the study period
Method of measurement
Using a digital device
5
Description
Respiratory rate
Timepoint
Before and after dialysis and at each dialysis session until the end of the study period
Method of measurement
Using an examination by a researcher
6
Description
Tempreture
Timepoint
Before and after dialysis and at each dialysis session until the end of the study period
Method of measurement
Using a digital device
7
Description
O2 Saturation
Timepoint
Before and after dialysis and at each dialysis session until the end of the study period
Method of measurement
Using a digital device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with chronic renal failure with at least three months of hemodialysis undergo exercise for thirty minutes in two 15-minute phases during the first two hours of dialysis. The activity is performed using a pedal that is installed at the bottom of the patient's bed. There is an interval of fifteen minutes for rest during activity. Before the intervention, participants warm up for five minutes and then slowly cool off by pedaling. The pedaling intensity will be such that the patient reaches a 10% increase in pulse rate compared to the pulse rate before starting the activity. The safe range of pulse rate in patients at the time of activity is considered to be a minimum of 50 and a maximum of 125 beats per minute.
Category
Rehabilitation
2
Description
Control group: Patients with chronic renal failure with at least three months of hemodialysis will undergo 4-hour routine dialysis.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bushehr Shohadaye Khalige Fars Hospital
Full name of responsible person
Mahmoud Mohamadizadeh; student of master degree
Street address
Taleghani Ave.
City
Bushehr
Province
Boushehr
Postal code
7434159614
Phone
+98 77 3345 5374
Fax
+98 77 3345 5379
Email
mahmoud.2580@yahoo.com
2
Recruitment center
Name of recruitment center
Salman Farsi hospital
Full name of responsible person
Mahmoud Mohamadizadeh; student of master degree
Street address
Sazabad Ave.
City
Bushehr
Province
Boushehr
Postal code
7518759416
Phone
+98 77 3344 2815
Fax
+98 77 3344 2829
Email
mahmoud.2580@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Khamisipour
Street address
Vice chancellor for research, Bushehr University of Medical Sciences, Rishehr avenue, Sabzabad avenue
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0178
Email
mahmoud.2580@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Dr. Shahnaz Pooladi
Position
Head of the Bushehr Nursing Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Sabzabad avenue
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Email
pouladi2008@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Dr. Shahnaz Pooladi
Position
Head of the Bushehr Nursing Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of nursing and midwifery, Bushehr University of medical sciences, Rishehr avenue, Sabzabad avenue
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Email
pouladi2008@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Dr. Shahnaz Pooladi
Position
Head of the Bushehr Nursing Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of nursing and midwifery, Bushehr University of medical sciences, Rishehr avenue, Sabzabad avenue
City
Bushehr
Province
Boushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Email
Pouladi2008@yahoo.com
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