The purpose of this study was to determine the effect of 8 weeks of aerobic exercise with propolis supplementation on biomarkers of oxidative stress in hemodialysis patients
Design
A randomized, double-blind randomized controlled trial with a sample size of 60 patients
Settings and conduct
In this study, 60 adult patients aged 30 to 65 years with renal failure undergoing hemodialysis at Ale Muhammad Medical polyclinic and Emergency service in Mashhad, were selected based on inclusion criteria and randomly divided into four groups of study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. An age range of 18 to 65 years; 2. ESRD patients on hemodialysis treatment; 3. Perform hemodialysis 3 days a week; 4. Willingness to participate in research. Exclusion criteria: 1. BMI above 30 kg/m; 2. Having diseases such as gallstones, cancer, and acute diseases; 3. Acute heart accident in the past year; 4. Taking any medicine outside the routine treatment protocol of hemodialysis patients; 5. Any allergy to honey and its compounds; 6. Smoking, drug addiction or alcohol consumption
Intervention groups
Four groups of intervention and control; the first group received 500 mg of propolis per day, 2 capsules containing 250 mg Propolis extract with 3 days a week exercise program with a stationary bike, the second group received 500 mg of propolis per day, 2 capsules containing 250 mg Propolis extract, the third group received 500 mg of placebo per day, 2 capsules containing 250 mg placebo with 3 days a week exercise program with a stationary bike, the fourth group received 500 mg of placebo per day, 2 capsules containing 250 mg placebo extract for 8 weeks.
Main outcome variables
Malondialdehyde; Total antioxidant capacity; Systolic and diastolic pressure; Nutritional status; Anthropometric indicators
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220102053595N1
Registration date:2022-02-17, 1400/11/28
Registration timing:prospective
Last update:2022-02-17, 1400/11/28
Update count:0
Registration date
2022-02-17, 1400/11/28
Registrant information
Name
Sina Hamidi pour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3876 5642
Email address
hamidipour.sina.nu@mshdiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-19, 1400/11/30
Expected recruitment end date
2022-04-16, 1401/01/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 8 weeks of aerobic exercise with propolis supplementation on biomarkers of oxidative stress in hemodialysis patients
Public title
The effect of propolis supplementation in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
An age range of 18 to 65 years
ESRD patients on hemodialysis treatment
Perform hemodialysis 3 days a week
Absence of any physical abnormalities or bone diseases that interfere with their physical activity
Willingness to participate in research
Exclusion criteria:
BMI above 30 kg/m
Disease (gallstones, cancer, and acute disease)
Acute heart accident in the past year
Taking any medicine outside the routine treatment protocol of hemodialysis patients
Use of oral and injectable nutritional supplements except nephrovit and iron supplements according to the protocol
Any allergy to honey and its compounds
Leaving the patient with his/her personal consent
Smoking, drug addiction or alcohol consumption
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Among the patients with renal failure undergoing hemodialysis referred to Ale Muhammad Medical polyclinic and Emergency service in Mashhad, 60 patients will be selected based on inclusion criteria and personal satisfaction and will be matched according to age and gender, then randomly assigned to one of four intervention and control groups. Patients will be randomly divided into intervention and control groups using statistical software and block randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
The capsules are standardized in all groups in terms of appearance, color, and odor. From the selection of the person, no one will be aware of the type of treatment he/she will receive. Finally, data and information are given to the statistician with a special code for each group, so that the statistician can also be blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad University- Mashhad Branch
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
9164697515
Approval date
2022-01-19, 1400/10/29
Ethics committee reference number
IR.IAU.MSHD.REC.1400.134
Health conditions studied
1
Description of health condition studied
End stage renal disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Malondialdehyde
Timepoint
At the beginning and end of the study
Method of measurement
kit
2
Description
Total antioxidant capacity
Timepoint
At the beginning and end of the study
Method of measurement
kit
3
Description
Systolic blood pressure
Timepoint
At the beginning and end of the study
Method of measurement
Mercury manometers
4
Description
Diastolic blood pressure
Timepoint
At the beginning and end of the study
Method of measurement
Mercury manometers
5
Description
Nutritional status
Timepoint
At the beginning and end of the study
Method of measurement
Food recall and 3-day food record questionnaires
6
Description
Anthropometric indicators
Timepoint
At the beginning and end of the study
Method of measurement
Weighing scale, Tape measure, BIA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the first group received 500 mg of propolis per day, 2 capsules containing 250 mg Propolis extract, 1 capsule before lunch, and 1 capsule before dinner, with 3 days a week exercise program with a stationary bike according to the protocol for 8 weeks. Propolis capsules have been prepared by Shahdineh Golha Honey Company located in Najafabad, Isfahan, and propolis extract has been extracted alcoholically.
Category
Treatment - Drugs
2
Description
Intervention group: the second group received 500 mg of propolis per day, 2 capsules containing 250 mg Propolis extract, 1 capsule before lunch, and 1 capsule before dinner, without exercise for 8 weeks. Propolis capsules have been prepared by Shahdineh Golha Honey Company located in Najafabad, Isfahan, and propolis extract has been extracted alcoholically.
Category
Treatment - Drugs
3
Description
Control group: the third group received 500 mg of placebo per day, 2capsules containing 250 mg placebo, 1 capsule before lunch, and 1 capsule before dinner, with 3 days a week exercise program with stationary bike according to the protocol for 8 weeks
Category
Placebo
4
Description
Control group: the fourth group received 500 mg of placebo per day, 2 capsules containing 250 mg placebo extract, 1 capsule before lunch, and 1 capsule before dinner, without exercise for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ale Muhammad Medical polyclinic and Emergency service
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Individually nonidentifiable information of participants will be shared in this study. Also, the protocol, results and statistical analysis of the study will be published in the relevant articles.
When the data will become available and for how long
Unidentifiable personal information of the participants will be available after the publication of the related articles.
To whom data/document is available
Unidentifiable personal information of the participants will be made available to other researchers at academic institutions.
Under which criteria data/document could be used
Unidentifiable personal information of participants can only be used for research
From where data/document is obtainable
send an email: hamidipour.sina.nu@mshdiau.ac.ir
What processes are involved for a request to access data/document
Researchers in academic institutions can send their request by e-mail to the mentioned email. The data will be sent to them after consulting and approving the research team.