Protocol summary
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Study aim
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Investigating the effect of isotonic exercise on attitude towards life, appetite, happiness, and hemodialysis adequacy in patients undergoing hemodialysis
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Design
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A controlled clinical trial with parallel groups, without blinding, randomized using block randomization on 80 patients
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Settings and conduct
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This study will be conducted in the dialysis unit of Qom Kamkar Hospital. Blinding will not be performed in this study. In the control group, patients will be encouraged to perform range-of-motion exercises during hemodialysis. In the intervention group, patients will perform isotonic exercises for 30 minutes during hemodialysis.
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Participants/Inclusion and exclusion criteria
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Major inclusion criteria: age over 18 years and a history of at least six months of hemodialysis; Major exclusion criteria: the patient refuses to continue participating in the study
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Intervention groups
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In the control group, patients will be encouraged to perform range-of-motion exercises during hemodialysis. In the intervention group, patients will perform isotonic exercises for 30 minutes during hemodialysis.
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Main outcome variables
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Improvement in patients' attitude towards life, appetite, happiness, and dialysis adequacy
General information
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Reason for update
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Adding the attitude towards life variable as a dependent variable
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150724023314N6
Registration date:
2025-07-30, 1404/05/08
Registration timing:
prospective
Last update:
2026-02-07, 1404/11/18
Update count:
1
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Registration date
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2025-07-30, 1404/05/08
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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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2025-08-06, 1404/05/15
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Expected recruitment end date
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2026-03-20, 1404/12/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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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 isotonic exercise on attitude towards life, appetite, happiness, and hemodialysis adequacy in patients undergoing hemodialysis
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Public title
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The effect of isotonic exercise in patients undergoing hemodialysis
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
All hemodialysis patients who have been undergoing dialysis for more than 6 months
Exclusion criteria:
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Age
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From 18 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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No information
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants will be assigned to intervention and control groups using block randomized method. The link "https://www.sealedenvelope.com/simple-randomiser/v1/lists" will be used for block randomization. For this purpose, the target number of samples (120 samples including sample loss), number of groups (two groups A and B) and number of blocks (4) will be entered and the system will provide the researcher with a list of 4 blocks. Based on the output list, it will be determined in which group the patients who enter the study should be placed in order. Items A represent the intervention group and items B represent the control group.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not 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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2025-04-13, 1404/01/24
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Ethics committee reference number
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IR.MUQ.REC.1404.005
Health conditions studied
1
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Description of health condition studied
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Renal failure
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ICD-10 code
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N17
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ICD-10 code description
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Acute kidney failure
Primary outcomes
1
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Description
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Hemodialysis adequacy
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Timepoint
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Before the start of the intervention and immediately after its completion
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Method of measurement
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Measurement of blood creatinine levels
2
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Description
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Appetite level
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Timepoint
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Before the start of the intervention and immediately after its completion
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Method of measurement
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Simplified Nutritional Appetite Questionnaire
3
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Description
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Happiness
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Timepoint
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Before the start of the intervention and immediately after its completion
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Method of measurement
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Oxford Happiness Inventory
4
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Description
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attitude towards life
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Timepoint
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Before the start of the intervention and immediately after its completion
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Method of measurement
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Attitude towards life inventory
Intervention groups
1
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Description
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Intervention group: For a period of 8 weeks, isotonic exercises will be performed for 30 minutes during dialysis.
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Category
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Rehabilitation
2
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Description
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Control group: For a period of 8 weeks, patients will be encouraged to move their limbs within the range of motion during dialysis
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Category
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Prevention
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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Yes
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Title of funding source
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Ghoum University of Medical Sciences
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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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable