Effect of intradialytic aerobic exercise on quality of life, lower limb strength, dialysis adequacy and inflammatory marker
Design
In this randomized controlled clinical trial, 36 patients are enrolled into two groups, intervention and control groups, using randomized block design method by Random Allocation Software.
Settings and conduct
In the hemodialysis center, 36 patients who are randomly divided into control and intervention groups will undergo hemodialysis in two separate environments. َAfter the patient is attached to the hemodialysis machine for 30 minutes, their vital signs are checked and documented. Then the patient starts pedaling for at least 30 minutes. Their vital signs are checked and documented every 15 minutes and also at the end of the exercise.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients who are on hemodialysis treatment 3 times a week for at least 6 months
Exclusion criteria: Existence of underlying cardiopulmonary disease and uncontrolled blood pressure, as well as musculoskeletal problems that make it impossible to cycle.
Intervention groups
In the intervention group, patients will cycle for 6 months at least 3 times a week, for 30 minutes during the first 2 hours of dialysis. Patients in the control group will have their routine hemodialysis at least 3 times a week for 4 hours during the 6 months.
Main outcome variables
Lower Limb Strength; Quality of Life; Dialysis Adequacy; hsCRP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080916001256N2
Registration date:2020-11-05, 1399/08/15
Registration timing:retrospective
Last update:2020-11-05, 1399/08/15
Update count:0
Registration date
2020-11-05, 1399/08/15
Registrant information
Name
Maryam Hami
Name of organization / entity
Health Organization
Country
Iran (Islamic Republic of)
Phone
+98 51 1765 9556
Email address
hamim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-07-26, 1399/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intradialytic aerobic exercise on quality of life, lower limb strength, dialysis adequacy, and hsCRP
Public title
Effect of cycling during hemodialysis on patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients who are on hemodialysis treatment 3 times a week for at least 6 months
Exclusion criteria:
Active stable angina
History of myocardial Infarction (MI) in the previous month
Congestive Heart Failure (CHF) (grade III, IV)
Chronic hyperkalemia
Active liver disease
Musculoskeletal disorders
Lower limb amputation
Vascular access disorders
Resistant Hypertension
History of surgery in the previous month
Peripheral neuropathy
Dementia
Malignancies
Active Inflammation
(Parathormone)PTH>1000
History of femur fraction
Poor control diabetes mellitus
Intake of immunosuppressant drugs
tempreture>38'
Hemodynamic disorders
Cerebrovascular disease
Active lung disease
CardiacEjection Fraction (EF)<45%
Hemoglobin<10 g/dL
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Random blocks with variable sizes of 4 to 6 with a random sequence of colored leaves are designed in Random Allocation Software and are provided to the secretary in sealed packages. For each patient, one of the envelopes will be opened and the sheet on top is handed to the patient.
According to the color of the paper, the patient will be categorized in one of the groups and will be registered in the relevant color list.
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 Mashhad University Of Medical sciences
Street address
Vice President of Research, Ghoreshi building, Daneshgah st.
City
Mashhad
Province
Razavi Khorasan
Postal code
91767-99199
Approval date
2020-01-14, 1398/10/24
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.110
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
Z49.31
ICD-10 code description
Encounter for adequacy testing for hemodialysis
2
Description of health condition studied
Chronic kidney disease (CKD)
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
3
Description of health condition studied
Hemodialysis
ICD-10 code
Z99.2
ICD-10 code description
Dependence on renal dialysis
Primary outcomes
1
Description
Lower Limb Strength
Timepoint
Measuring the duration of Sit-to-Stand 10 test at the beginning of study (before intervention), 3 and 6 months after cycling during hemodialysis (intervention)
Method of measurement
Chronometer
Secondary outcomes
1
Description
Dialysis Adequacy
Timepoint
Measuring ِdialysis adequecy at the beginning of study (before intervention), 3 and 6 months after cycling during hemodialysis (intervention)
Method of measurement
Measuring the levels of Urea before and after a dialysis session and calculating dialysis adequacy by collecting blood sample and measuring them with biochemical autoanalyzer
2
Description
Score of quality of life in Kidney Disease Quality of Life Instrument (KDQOL-36)
Timepoint
Measuring the score of quality of life with Kidney Disease Quality of Life Instrument (KDQOL-36) at the beginning of study (before intervention), 3 and 6 months after cycling during hemodialysis (intervention)
Method of measurement
Kidney Disease Quality of Life Instrument (KDQOL-36) Questionnaire
3
Description
High-sensitivity C-Reactive Protein (hs-CRP)
Timepoint
Measuring the plasma levels of High-sensitivity C-Reactive Protein (hs-CRP) at the beginning of study (before intervention), 3 and 6 months after cycling during hemodialysis (intervention)
Method of measurement
Measuring the plasma level of High-sensitivity C-Reactive Protein (hs-CRP) by venous blood sampling and measuring them with biochemical autoanalyzer
Intervention groups
1
Description
Intervention group: In the hemodialysis center, patients who meet the inclusion criteria are randomly divided into two groups of intervention and control after obtaining informed consent. In the intervention group, patients will cycle for 6 months, at least 3 times a week, for 30 minutes during the first 2 hours of dialysis, so that the first 5 minutes are for warming up, 20 minutes for maximal activity, and the last 5 minutes for cooling down. Bikes are portable and will be fixed to the bed. Vital signs of patients will be examined and charted at least 3 times per session.
Category
Other
2
Description
Control group: Patients undergoing hemodialysis treatment with at least 6 months of hemodialysis history, who are eligible but reluctant to enter the study are registered in the plan. Patients will undergo routine hemodialysis for the next 6 months, at least 3 times a week for 4 hours.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sabzdarman Hemodialysis Clinic
Full name of responsible person
Dr. Hamid Taravati
Street address
n. 130, Kolahdouz 18 Ave., Kolahdouz Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9183868551
Phone
+98 51 3843 8828
Email
htaravati@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi Dr.
Street address
Vice President of Research- Ghoreshi building- Daneshgah st.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176799199
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
23
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
2
Sponsor
Name of organization / entity
SabzDarman Clinic
Full name of responsible person
Dr. Hamid Taravati
Street address
n. 130, Kolahdouz 18 Ave., Kolahdouz Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9183868551
Phone
+98 51 3843 8828
Email
htaravati@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
SabzDarman Clinic
Proportion provided by this source
77
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Arash Sefidgaran
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
n. 130, Kolahdouz 18 Ave., Kolahdouz Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9183868551
Phone
+98 51 3843 8828
Email
arash.sefid@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Hami
Position
Associated Professor Of Nephrology
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Ghaem Hospital, AhmadAbad Ave., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3801 2837
Fax
Email
hamim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Arash Sefidgaran
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
n. 130, Kolahdouz 18 Ave., Kolahdouz Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9183868551
Phone
+98 51 3843 8828
Email
arash.sefid@gmail.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
The data can be used to research and provide new solutions by citing the source.
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