An interventional study of Home-based Tele Exercise in End-Stage Renal Disease and Hemodialysis Complication, sponsored by Pardis Specialized Wellness Institute. Completed at 1 site in Iran. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-12.
Sponsored by Pardis Specialized Wellness Institute · Not applicable, Interventional, and Supportive care
This study evaluates the effects of synchronous home-based tele-exercise on postural abnormalities (FHP and hyper-kyphosis) in dialysis patients. It aims to assess improvements in balance, physical function, and quality of life while reducing fatigue and fall risk.
End-stage renal disease, as one of the serious problems of public health, can significantly influence Musco skeletal system, physical unction and quality of life in dialysis patients. As a result of the treatment limitations, dialysis patients often suffer from postural abnormalities such as hyper-kyphosis and forward head posture (FHP), directly impacting their balance, daily physical activities and fall risk. Such physical issues, coupled with reduced balance and physical capacity can significantly increase the risk of serious injuries such as fractures of hip and spine.
Kyphosis, an abnormal curvature of the spine, result in noticeable changes not only in the pulmonary function but also in the cardiopulmonary capacity. Furthermore, FHP, the forward displacement of the head in the sagittal plane relative to the shoulders, lead to muscular imbalances including the shortening and tightening of the upper trapezius as well as the weakening of the deep flexor muscles of neck around the cervical spine. In addition to affecting body balance and stability, this condition result in a number of problems such as the neck pain, functional disorders and tension headaches. Main factors contributing to those abnormalities include muscular weakness, reduced bone density and a sedentary life style exacerbated by the specific nature of dialysis treatment. Dialysis patients are also at a higher risk of sarcopenia and osteoporosis subsequently affecting their mobility and risk of falls.
Regular exercises, especially home-based ones, could positively influence postural abnormalities and physical function in dialysis patients. Studies have shown that home-based resistance and aerobic exercises improve bone density, standing balance and physical function. Such programs are considered a suitable option for dialysis patients as a result of their ease of implementation as well as the diminished costs associated with visiting the medical centers.
Despite numerous evidence on the positive effect of exercise on dialysis patients, there is not sufficient research on the effect of home-based exercises on hyper-kyphosis and FHP. Particularly, the effect of such programs on dynamic balance require further investigation. Additionally, only a few studies have comprehensively evaluated the weakness and fatigue indicators in these patients.
To improve the effectiveness of home-based exercises, they should be tailored to the patients' personal requirements. These programs can significantly increase the life quality, aerobic capacity and balance indicators despite the challenge of low retention rate.
The investigators hypothesize that synchronous home-based tele-exercise would have a positive impact on reducing the prevalence of physical abnormalities, including FHP and hyper kyphosis, in dialysis patients. The investigators also expect an improvement in their physical function, balance and quality of life while decreasing fatigue.
In this study, the investigators aim to investigate how home-based exercises affect the prevalence of hyper-kyphosis and FHP in dialysis patients. Additionally using standard methods, the investigators evaluate the impact of these abnormalities on patients' balance and physical function and present preventive solutions to reduce fall risks. As for the secondary goals, the investigators aim to evaluate the final effects on quality of life and fatigue indices of hemodialysis patients.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's enrollment of 30 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
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Exclusion Criteria:
The participants (n = 15) in the study group will be given an online personalized exercise program at home in hemodialysis (HD). Each session will be 40 to 45 min in duration for 3 days per week over 12 weeks, 36 sessions in total.
Behavioral: Home-based Tele Exercise
Patients allocated to the control group (n = 15) will receive their standard nephrological care. Through the 12-week period, all control participants will be instructed to maintain the standard treatment regimen and to maintain their customary dietary and physical activity patterns.
The participants in the study group will be given an online personalized exercise program at home in hemodialysis (HD) days. Synchronous tele-exercise will be delivered using the free teleconference application (app) (Google Meets software). The groups of tele-exercises will be private, and the professional will send the link for each training session and will control the access of the participants.
Rate of changes in hyper-kyphosis
Evaluating the effect of home-based exercise on hyper-kyphosis using the Debrunner Kyphometer, a non-radiologic gold standard tool. This device measures the kyphosis angle by positioning its arms on the spinous processes of T2-T3 (upper point) and T11-T12 (lower point), with direct angle readings from the calibrated scale. Measurements are taken in degrees, with hyper-kyphosis defined as ≥53° in women and ≥55° in men.
Time frame: Pre-test and 3 Months Later (Post-test)
Rate of changes in forward head posture
Evaluating the effect of home-based exercise on forward head posture craniocervical angle (CVA) analysis using digital photogrammetry. Reflective markers are placed on the C7 spinous process and the tragus of the ear, followed by lateral image capture at a standardized 1.5-meter distance. Image analysis software, such as Kinovea, automatically calculates the CVA angle. A normal posture is defined as CVA ≥53°, while a severe forward head posture is \<50°.
Time frame: Pre-test and 3 Months Later (Post-test)
Rate of changes of balance and fall risk
Assessing balance improvements and fall risk reduction using Timed Up and Go (TUG) Test duration (unit: seconds, Time required to rise, walk 3 meters, turn, and return; diagnostic threshold ≥12 seconds indicates fall risk).
Time frame: Pre-test and 3 Months Later (Post-test)
Rate of changes of physical function
Evaluating physical function improvement using the 6-minute walk test (6MWT), which measures the maximum distance covered in 6 minutes (unit: meters). Reference values: 400-700 meters for older adults and 150-346 meters for heart failure patients.
Time frame: Pre-test and 3 Months Later (Post-test)
Rate of changes of daily physical activity level
Assessing the effect of home-based exercise on daily activity levels using the LowPAQ questionnaire which evaluates physical activity across occupational, transportation, household, leisure, and sedentary domains, with scoring in MET-minutes per week for light (3.3 MET), moderate (4.0 MET), and vigorous (8.0 MET) activities. Activity levels are categorized as low (\<600 MET-min/week), active (600-3000 MET-min/week), and highly active (\>3000 MET-min/week), aligned with WHO guidelines.
Time frame: Pre-test and 3 Months Later (Post-test)
Rate of changes of fatigue levels
Measuring fatigue levels before and after the intervention using Fatigue Severity Scale (FSS) (9 items on a Likert scale 1-7 (total range 9-63); Score interpretation: ≥36 indicates clinical fatigue, ≤18 indicates no fatigue. ICC = 0.91)
Time frame: Pre-test and 3 Months Later (Post-test)
Rate of changes of quality of life
Evaluating improvements in quality of life using the KDQOL-36 questionnaire, which includes SF-12 (general health, reported as a T-score with a mean of 50) and kidney disease-specific subscales: burden of kidney disease (0-100), symptoms and problems (0-100), and effects of kidney disease (0-100). The Kidney Summary Score (KSS) is calculated as the average of the three kidney-specific subscales.
Time frame: Pre-test and 3 Months Later (Post-test)
Plan to share: Yes — Individual participant data (IPD) underlying the results reported in the published article will be shared after deidentification.
Supporting information: Study protocol, Sap
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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