Protocol summary
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Study aim
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Studying the effect of 12 weeks of combined exercises and curcumin consumption on serum ferritin and serum albumin in hemodialysis (HD) patients
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Design
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A clinical trial with a control group with parallel groups without blinding and randomized with a table of random numbers with 80 patients.
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Settings and conduct
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In this research, the subjects are selected from HD patients after being called and invited to participate in Khurshid HD Center of Isfahan according to the criteria for entering with the approval of specialist doctors and then they sign informed consent. They will be randomly assigned to one of the four groups, exercise group, supplement group, exercise and supplement group and control. will be placed. The intervention includes 12 weeks of combined exercises, which each week includes 3 exercise sessions for 45 minutes and 12 weeks of taking 2 curcumin supplements daily after the main meal.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:undergoing HD for at least 1, having inflammation and agreeing to participate, exclusion criteria: having medical contraindications for exercise and taking curcumin
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Intervention groups
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Intervention group (IG)1: Training group performing exercise for 12 weeks; 3 sessions weekly, each for 45 minutes. Exercise training consists of 3 bouts of resistance with 12 repetitions, and 3 bouts of aerobic exercise with 15 repetitions. IG 2: supplemented with curcumin capsules, taking 2 capsules daily (equivalent to 1000 ml grams of curcumin (preferably to be consumed after the main meal). IG3: exercise and supplement consumption group, who performed the same exercise protocol as the exercise group and in addition, consumed 1000 mg of curcumin supplement daily for 12 weeks. Control group: They did not have any sports activities and supplement consumption.
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Main outcome variables
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Serum ferritin, serum albumin, 6-minute walking test
General information
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Reason for update
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End of recruitment
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200819048461N2
Registration date:
2022-12-21, 1401/09/30
Registration timing:
prospective
Last update:
2023-02-16, 1401/11/27
Update count:
1
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Registration date
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2022-12-21, 1401/09/30
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-01-03, 1401/10/13
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Expected recruitment end date
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2023-01-24, 1401/11/04
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Actual recruitment start date
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2023-01-08, 1401/10/18
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Actual recruitment end date
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2023-01-31, 1401/11/11
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Trial completion date
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empty
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Scientific title
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The effect of cimbination of exercise and curcumin supplementation on serum ferritin and serum albumin in hemodialysis patients
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Public title
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The effect of exercise and curcumin on hemodialysis disease
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age between 18 and 80 years
More than three months of dialysis experience
Having a three-time hemodialysis program
No heart attack and stroke in the past three months
Having the ability to communicate with others
The permission of the attending physician to practice
be clinically stable
Exclusion criteria:
Unstable heart condition (angina, congestive heart failure, severe arterial stenosis, uncontrolled arrhythmias, etc.)
Active infection or acute medical illness
Hemodynamic instability, unstable blood sugar
unable to exercise (lower limb amputation without prosthesis)
Having severe skeletal-muscular pain at rest or minimal activity
Having shortness of breath while resting or with daily activities
Allergy or insensitivity to turmeric
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Age
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From 18 years old to 80 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
80
Actual sample size reached:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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En Simple randomization, individual with random number generation program
Randomization was performed by a biostatistician using a computer-generated randomization program [using Stata 16, StataCrop, College Station, Tx] with an allocation ratio of 1:1.
For allocation concealment, allocation information will be protected in opaque sealed envelopes by an identified individual not participating in the study. Only after participant registration and baseline measurements are completed will envelopes be opened.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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One of the experimental groups of the research was the exercise + supplement group, which received the supplement in the form of capsules along with doing sports exercises, and the second experimental group was the exercise group, which only exercised and a capsule that looked similar to the supplement capsule but contained He was receiving curcumin.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-09-05, 1401/06/14
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Ethics committee reference number
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IR.IAU.KHUISF.REC.1401.168
Health conditions studied
1
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Description of health condition studied
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End stage renal disease
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ICD-10 code
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N18.5
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ICD-10 code description
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Chronic kidney disease, stage 5
Primary outcomes
1
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Description
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The normal level of ferritin in serum is between 10 and 300 nanograms per milliliter, and ferritin levels above 200 nanograms per milliliter in women and above 300 nanograms per milliliter in men have been diagnosed as abnormal. Serum ferritin levels in hemodialysis patients measurement of serum ferritin in the bloodstream can be useful for monitoring the progress of hemodialysis disease.
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Timepoint
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Ferritin measurement of the subjects' blood was done in two stages, the first stage in the initial blood sampling, i.e. 24 hours before the start of the exercise protocol and curcumin supplementation, and the second stage in the blood sample of the last stage, three months after the last exercise session and the last curcumin intake a done.
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Method of measurement
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To measure serum ferritin, it was measured and recorded using the ARKA kit by ELISA method (Enzyme-linked immunoadsorbent assay).
2
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Description
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Serum albumin level, the normal level of serum albumin is between 4.3 and 4.5 grams per deciliter, and hemodialysis patients have low albumin levels. Measuring the amount of serum albumin in the bloodstream can be useful for monitoring the progress of hemodialysis patients.
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Timepoint
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Measuring the blood albumin of the subjects in two stages, the first stage in the initial blood sampling, i.e. 24 hours before the start of the exercise protocol and taking curcumin supplement and the second stage, in the final stage blood sampling, three months after the last session of sports training and the last curcumin intake a done .
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Method of measurement
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The amount of albumin was measured and recorded by the Bionik laboratory kit, using the autoanalyzer olympus model AU made in Iran.
Secondary outcomes
1
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Description
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Functional status
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Timepoint
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Before starting exercise and taking curcumin and three months later
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Method of measurement
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6-minute walking test
Intervention groups
1
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Description
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The first intervention group :the experimental group will do 3 sessions of 45-minute exercise program per week at home on non-dialysis days with the simultaneous supervision of an online trainer for 12 weeks. These exercises are taught face-to-face in the first week. resistance exercises (2 sets of 12 repetitions, including anterior and posterior knee strengthening, lateral hip joint strengthening (adductors and abductors), strengthening of the anterior and posterior leg system, rest period between sets 30 to 60 secondsconsidered) aerobic exercise (3 turns of 15 repetitions of walking backwards, walking and turning, walking sideways, stopping on heels and toes, walking on heels and toes and walking on stairs). It is worth mentioning that before and after each training session, the subjects performed static stretching and softening movements to warm up and cool down the body.
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Category
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Treatment - Other
2
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Description
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The second intervention group :The experimental group will receive curcumin supplements in the form of capsules for 12 weeks, in such a way that these capsules will be delivered to them once every 3 weeks. All capsules will be the same in terms of shape, quantity, size, and color.Theparticipants will be asked to take 2 capsules of curcumin daily (equivalent to 1000 mg of curcumin) preferably after the main meal.
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Category
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Placebo
3
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Description
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The third intervention group : the exercise group was +supplement. The subjects in this group, along with the exercise group, performed combined exercises, and during the research period, they received 1000 mg of curcumin supplement (manufactured by Dineh company) daily for 12 weeks.
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Category
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Treatment - Other
4
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Description
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Control group: Subjects in this group did not do any exercise during the research period (12 weeks) and did not receive any supplements
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Islamic Azad University of Khorasgan, Isfahan
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The results of the study group are made available
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When the data will become available and for how long
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After october 2023
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To whom data/document is available
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Only academics are allowed
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Under which criteria data/document could be used
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If the data is used for the purpose of research in the field of variables and providing new solutions, it can be used by mentioning the source
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From where data/document is obtainable
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by email m.tabibi@ut.ac.ir
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What processes are involved for a request to access data/document
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It will be answered within one month after receiving the email
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Comments
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