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IRCT20080916001256N2 IRCT 2020-11-05 Mashhad University of Medical Sciences Effect of cycling during hemodialysis on patients Effect of intradialytic aerobic exercise on quality of life, lower limb strength, dialysis adequacy, and hsCRP 2020-07-22 anticipated 36 Complete https://irct.ir/trial/49255 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A Condition 1: Hemodialysis. Condition 2: Chronic kidney disease (CKD). Condition 3: Hemodialysis. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Unidentifiable data from individuals and related information will be shared with other researchers. Study protocol, data analysis program, etc, will be shared When: Access to data is always available. To whom: All researchers are allowed to use. Conditions: The data can be used to research and provide new solutions by citing the source. Where to obtain: See the email of the researcher or the journal in which the article has been published How to obtain: Search in the Internet by using keywords and selecting titles or requesting them by sending an email to the researcher Comments:
public Dr. Arash Sefidgaran
n. 130, Kolahdouz 18 Ave., Kolahdouz Blvd, Mashhad
Mashhad Iran (Islamic Republic of) 9183868551 +98 51 3843 8828 arash.sefid@gmail.com Mashhad University of Medical Sciences scientific Maryam Hami
Ghaem Hospital, AhmadAbad Ave., Mashhad
Mashhad Iran (Islamic Republic of) 91766-99199 +98 51 3801 2837 hamim@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) patients who are on hemodialysis treatment 3 times a week for at least 6 months no limit no limit Both 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 Z49.31 N18.5 Z99.2 Encounter for adequacy testing for hemodialysis Chronic kidney disease, stage 5 Dependence on renal dialysis Other Other 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. 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. 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. 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. 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. 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. SabzDarman Clinic Mashhad University of Medical Sciences SabzDarman Clinic Approved 2020-01-14 Ethics Committee of Mashhad University Of Medical sciences Vice President of Research, Ghoreshi building, Daneshgah st. Mashhad Razavi Khorasan Iran (Islamic Republic of)