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IRCT20200819048461N5 IRCT 2026-08-08 Pardis Specialized Wellness Institute The effect of home-based synchronous tele-exercise on balance, risk of fall, abnormality of posture, quality of life, level of physical activity and physical function in dialysis patients Comparing the effect of home-based synchronous tele-exercise on balance, fall risk, postural abnormalities, quality of life, physical activity level, and functional status in hemodialysis patients 2026-09-23 anticipated 60 Pending https://irct.ir/trial/87274 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This study is a randomized controlled clinical trial with a parallel-group design and blinded outcome assessment. The unique feature of this trial is the comparison of home-based corrective exercise with synchronous online coach supervision in the intervention group versus the same exercise program without online supervision in the control group. Participants will be allocated using simple randomization with concealed allocation through opaque sealed envelopes, Randomization description: A simple random allocation sequence will be generated by an independent person using a random number generator software. Each allocation will be placed in a sequentially numbered, opaque, sealed envelope. After obtaining informed consent, the next envelope will be opened and the patient will be assigned to either the intervention or control group according to its content. Therefore, neither the researcher nor the patient is aware of the group assignment until the envelope is opened, Blinding description: The study is single-blind, and the collaborator who takes the functional tests from the patients and measures postural abnormalities with a flexible ruler and digital photography and completes the questionnaires will not be aware of the patient grouping. N/A End-stage renal disease requiring hemodialysis. Intervention 1: Intervention group:Experimental group (with coach supervision): 12 weeks; 3 sessions/week exercise program at home on non-dialysis days with synchronous online supervision by coach via WhatsApp. The exercise program includes: general warm-up (5 minutes), corrective and strength exercises (15 minutes) and general cool-down (10 minutes), with the main exercise body starting at 15 minutes and gradually increasing by adding sets and repetitions to 30 minutes over three months. After each exercise, a 30 to 60 second rest is given to the patient. Intervention 2: Control group (without supervision): Participants receive the same home exercise program in a printed booklet but perform the exercises independently without synchronous online supervision. Both groups continue to receive usual medical care. Yes - There is a plan to make this available What will be shared: The results of the study group are made available When: After publication of the main results To whom: Only academics are allowed Conditions: 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 Where to obtain: Dr. Mohammad Ali Tabibi via email address m.tabibi@ut.ac.ir How to obtain: It will be answered within one month after receiving the email Comments:
public Nasrin Salimian
71 Alley. Jey Street
Isfahan Iran (Islamic Republic of) 8156135414 0098 31 335252020 statisrin@gmail.com Pardis Specialized Wellness Institute scientific Dr. Mohammad Ali Tabibi
71 alley. Jey street
Isfahan Iran (Islamic Republic of) 8174757536 0098 31 335252020 m.tabibi@ut.ac.ir Pardis Specialized Wellness Institute Iran (Islamic Republic of) Age between 40 and 60 years At least three months of dialysis history Receiving hemodialysis three times per week No heart attack and stroke in the last three months Ability to communicate with others Doctor's permission for exercise 40 years 60 years Both Unstable cardiac status (angina, congestive heart failure, severe arterial stenosis, uncontrolled arrhythmias, etc.) Active infection or acute medical disease Individuals with medically diagnosed unstable blood glucose levels (fluctuations between hypoglycemia and hyperglycemia) Unable to exercise (lower limb amputation without prosthesis) Severe musculoskeletal pain at rest or minimal activity Shortness of breath at rest or with daily activities N18.6 End stage renal disease Rehabilitation Placebo Intervention group:Experimental group (with coach supervision): 12 weeks; 3 sessions/week exercise program at home on non-dialysis days with synchronous online supervision by coach via WhatsApp. The exercise program includes: general warm-up (5 minutes), corrective and strength exercises (15 minutes) and general cool-down (10 minutes), with the main exercise body starting at 15 minutes and gradually increasing by adding sets and repetitions to 30 minutes over three months. After each exercise, a 30 to 60 second rest is given to the patient. Control group (without supervision): Participants receive the same home exercise program in a printed booklet but perform the exercises independently without synchronous online supervision. Both groups continue to receive usual medical care. Balance. Timepoint: Before intervention; after 12 weeks. Method of measurement: Berg Balance Scale (BBS), a 14-item performance-based instrument (e.g., sit-to-stand, unsupported standing, 360° turn, single-leg stance), each item scored 0 (unable) to 4 (independent); total score range 0–56, with lower scores indicating greater balance impairment and fall risk. Administered by a trained, blinded assessor in a clinical setting over approximately 15–20 minutes. Fall risk. Timepoint: Before intervention; after 12 weeks. Method of measurement: Tinetti Performance-Oriented Mobility Assessment (POMA), comprising a balance subscale (9 items, max 16 points) and a gait subscale (7 items, max 12 points); total score 0–28, with <19 indicating high fall risk, 19–23 moderate risk, and ≥24 low risk. Administered via direct observation by an assessor blinded to group allocation. Forward head posture. Timepoint: Before intervention; after 12 weeks. Method of measurement: Craniovertebral angle (CVA) measured from a lateral-view digital photograph taken in natural standing posture; anatomical landmarks (spinous process of C7 and the tragus of the ear) are marked on the skin, and the angle between the horizontal line through the tragus and the line connecting the tragus to the C7 spinous process is calculated using AutoCAD (or equivalent angle-measurement software); a smaller angle indicates greater forward head posture severity (normal typically >50°). Kyphosis. Timepoint: Before intervention; after 12 weeks. Method of measurement: Thoracic kyphosis angle measured using a Flexible Ruler; the ruler is molded over the T1–T12 spinous processes with the patient in natural standing posture and the spinal curve traced onto paper; the kyphosis angle is then calculated from the traced curve using the trigonometric formula Kyphosis Angle = arctan(4H/L), where H is the height of the curve and L is the baseline length; higher values indicate greater kyphotic curvature. Quality of life. Timepoint: Before intervention; after 12 weeks. Method of measurement: Kidney Disease Quality of Life – Short Form (KDQOL-36), comprising the generic SF-12 core plus kidney disease–specific components (symptoms/problems, effects of kidney disease on daily life, burden of kidney disease); each domain is scored 0–100, with higher scores indicating better quality of life. Self-administered by the patient after the dialysis session, with assistance from the research collaborator if needed. Physical activity level. Timepoint: Before intervention; after 12 weeks. Method of measurement: Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire, covering approximately 41 physical and social activities; participants report frequency and duration of each activity over the past week; output is expressed as estimated weekly caloric expenditure (kcal/kg/week) and weekly hours of moderate-to-vigorous activity, with higher scores indicating greater physical activity. Administered as an interviewer-based questionnaire by a blinded research collaborator. Functional status. Timepoint: Before intervention; after 12 weeks. Method of measurement: Six-Minute Walk Test (6MWT), conducted per the American Thoracic Society (ATS) standard protocol; the patient walks at maximal comfortable pace along a flat 30-meter corridor for 6 minutes, and the total distance covered (in meters) is recorded; a greater distance indicates better functional exercise capacity. Performed on a non-dialysis day by a blinded assessor. Hospitalization. Timepoint: During the study (5 months). Method of measurement: Number and cause of hospital admissions during the 5-month study period, recorded via a researcher-made checklist based on medical record review and patient self-report at each dialysis session. Mortality. Timepoint: During the study (5 months). Method of measurement: Recording of mortality cases and cause of death during the 5-month study period, via a researcher-made checklist based on review of the dialysis center's medical records. Pardis Specialized Wellness Institute Approved 2022-10-22 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib Street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)