Comparison of the effect of two methods of aerobic and resistance exercises on the adequacy of dialysis and the quality of life in hemodialysis patients
Determination and comparison of the effect of aerobic and resistive exercises on the adequacy of dialysis and quality of life in hemodialysis patients
Design
This is a clinical trial with parallel groups.
Settings and conduct
In this study, the number of samples will be in full compliance with the criteria for inclusion. The sampling is done by referring to the hemodialysis section and selecting the patients who have the criteria for entering the study from the list of patients with fixed section is done. Then, these individuals will be randomly assigned to three groups of aerobic exercise, resistance and control. In this study, the data analyst does not know the allocation of study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Have at least six months of dialysis history
2. At least twice a week dialysis
3. No known ischemic disease based on history
4. Failure to record the history of heart attacks and angina during the last six months
5. Lung disease requiring artificial oxygen
6. No history of stroke or transient ischemic attacks during the past three months
7. Not having a disturbance in the musculoskeletal system and the leg in the leg that prevents the intended sporting activity (pedaling by bicycle).
8. No use of beta-blocker and no uncontrolled blood pressure
9. Do not interfere with another.
Exclusion criteria:
1- If the patient abstains from at least two sessions of the entire study session.
2. Cancellation of the patient from continuing the study
3. Failure to continue the study for various reasons, such as changing the dialysis process or patient's death
Intervention groups
Aerobic Exercise - Resistance
Main outcome variables
Dialysis adequacy; quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190120042436N2
Registration date:2019-05-26, 1398/03/05
Registration timing:prospective
Last update:2019-05-26, 1398/03/05
Update count:0
Registration date
2019-05-26, 1398/03/05
Registrant information
Name
Mohsen Salari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 4115
Email address
salarimo@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-05, 1398/03/15
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two methods of aerobic and resistance exercises on the adequacy of dialysis and the quality of life in hemodialysis patients
Public title
The effect of aerobic and resistance exercise on the adequacy of dialysis and the quality of life of hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have at least six months of dialysis history
At least twice a week dialysis
No known ischemic disease based on history
Not having the history of heart attacks and angina during the last six months
Lung disease requiring artificial oxygen
No history of stroke or transient ischemic attacks during the past three months
Not having a disturbance in the musculoskeletal system and the leg in the leg that prevents the intended sporting activity (pedaling by bicycle).
No use of beta-blocker and no uncontrolled blood pressure
At the same time, there is not under supervision of another study.
Exclusion criteria:
Having known ischemic disease based on history
Having a history of heart attacks and angina during the last 6 months.
Having pulmonary disease requiring artificial oxygen.
Having a history of stroke or transient ischemic attacks in the past three months.
Having Disorders of musculoskeletal system in the leg that prevent the exercise (bicycle pedaling).
Use of beta-blocker and uncontrolled blood pressure.
At the same time, there is under supervision of another study.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Firstly, according to the criteria for entering the patients who are willing to participate in the study, they are divided into three groups A, B, and C according to the formula. The two groups are divided into six groups according to formula (2): Draw the first illness in the middle section of the group, select the control group, the aerobic and resistance exercises, in the order indicated in the draw sheet. Again, the selected team will be returned to the Lottery Cup to complete the draw.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the data analyst does not know the allocation of study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Shahid Dr. Jalil St., Faculty of Nursing, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-94799
Approval date
2019-05-10, 1398/02/20
Ethics committee reference number
IR.YUMS.REC.1398.020
Health conditions studied
1
Description of health condition studied
Hemodialysis patients
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Dialysis adequacy
Timepoint
Before intervention and after intervention
Method of measurement
Formula
2
Description
Quality of life
Timepoint
Before and after the study
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Blood pressure
Timepoint
At the time of the intervention
Method of measurement
With a cardiopulmonary monitoring device
2
Description
Pulse
Timepoint
At the time of the intervention
Method of measurement
With a cardiopulmonary monitoring device
Intervention groups
1
Description
Intervention group: The first intervention group: For resistance exercise, warming up is a simple tensile movement in all four muscle groups in the form of flexion and extension of the elbow joint, the upper and lower sides of the arm.
Category
Rehabilitation
2
Description
The second intervention group: With use of a low-intensity bike, after warming the body for 5 minutes, for 15-60 minutes of exercise, according to protocol. The beginning of exercise for the first week will be as follows. First, a weight will be given to the patient who can only open his hand once (one maximum repetition) and then heals 60 to 65 percent of the weight of the above three training periods To be The number of repetitive exercises will be 8 to 10 times. The rest time will be 1 to 3 minutes after each round of training. The training of the following weeks will be done according to protocol. The duration of resistance exercise starts from 12-15 minutes in the first weeks and ends at 36-48 minutes in the seventh and eighth weeks.
Category
Rehabilitation
3
Description
Control group: Receive routine care.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Mohsen Salari
Street address
Shahid Dr. Jalil St., Faculty of Nursing, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-94799
Phone
+98 74 3233 5140
Fax
+98 74 3323 4115
Email
salarimo@yams.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Hossein Mari Oriad
Street address
Shahid Motahari Blvd., Vice Chancellor of Research, Yasuj University of Medical Sciences, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75917-41417
Phone
+98 74 3334 6078
Fax
+98 74 3334 6079
Email
en@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Mohsen Salari
Position
Ph.D. Pediatric Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Dr. Jalil St., Nursing School of Hazrat Zaynab (SA), Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-94799
Phone
+98 74 3323 5140
Fax
+98 74 3323 4115
Email
salarimo@yums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Mohsen salari
Position
Ph.D. Pediatric Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Dr. Jalil St., Faculty of Nursing, Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-94799
Phone
+98 74 3323 5140
Fax
+98 74 3323 4115
Email
salarimo@yamse.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Zahra Javid
Position
Master's degree in Internal Surgery Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Dr. Jalil St., Faculty of Nursing, Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-4799
Phone
+98 74 3323 5140
Fax
+98 74 3323 4115
Email
zahra.javid5093@gmail.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