An interventional study of Home-based 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 and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Pardis Specialized Wellness Institute · Not applicable, Interventional, and Supportive care
The objective of the trial is to assess key areas of uncertainty regarding the use of synchronous home-based tele-exercise in future practice and research, including issues relating to feasibility, safety and potential for efficacy.
Patients with renal failure undergoing maintenance dialysis (HD) therapy typically have very low levels of physical activity (PA), and this is associated with greatly increased morbidity and mortality.
According to studies, regular exercise is beneficial for patients at all stages, and the current recommendations for the prevention and management of side effects in HD patients, especially in the elderly, is regular exercise because it improves physical performance and PA . Currently, due to the unfamiliarity of dialysis center staff and nephrologists with the benefits of exercise, only 10% of the world's clinics have a plan to exercise during HD. Therefore, home-based exercise programs are a suitable option for patients to reduce their costs and make it easy to adhere to.
Home-based exercise has the potential to utilize higher volume and higher intensity training if activity is monitored. However, many of these programs are unsupervised and this is one of the major disadvantages of home-based exercise programs. Lack of prior knowledge about the safety and benefits of exercise programs, fear of injury, and lack of interest or motivation are barriers to exercise at home.
Tele-rehabilitation is rehabilitation services provided to patients from distant locations using information and communication technologies.Several studies have reported the use of e health-based self-management interventions in chronic kidney disease patients.
However, further research is needed to better understand the extent to which these techniques are acceptable, safe and potentially effective for supporting individuals undergoing HD treatment, given their unique needs and risk profile, is unknown. Our study seeks to address this gap by conducting a pilot evaluation of synchronous home-based tele-exercise intervention designed for HD patient.
Participants were recruited and clinically assessed at Khorshid Dialysis Center in Isfahan, Iran. Eligibility screening and baseline and post-intervention clinical assessments were conducted at Khorshid Dialysis Center. The Pardis Specialized Wellness Institute served as the study sponsor and coordinated the study procedures and the design of the home-based tele-exercise intervention. The synchronous tele-exercise intervention was prescribed, coordinated, and delivered online by the Pardis Specialized Wellness Institute.
Exclusion Criteria:
The participants in the study group will be given an online personalized exercise program at home in non dialysis days. 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 Exercise
Participants allocated to the control group will serve as a wait-list usual-care comparator. They will receive their usual nephrological care and will be instructed to maintain their usual treatment regimen and customary dietary and physical activity patterns without structured exercise during the 12-week control period. After study completion, they will be offered access to the same tele-exercise program.
The participants in the study group will be given an online personalized exercise program at home in non dialysis 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. Each session will be 40 to 45 min in duration for 3 days per week over 12 weeks, 36 sessions in total.
Recruitment rate
Determining recruitment as the number of randomized participants divided by the number of patients assessed for eligibility.
Time frame: 1 Month
Retention rate
Determining retention rate by the number of randomized participants completing the 12-week follow-up divided by the total number of randomized participants
Time frame: 12 Weeks
Adherence rate
Adherence will be quantified using two metrics. Overall session persistence will be calculated as the total number of sessions attended, including partially attended sessions, across all intervention participants divided by the total number of scheduled sessions across all intervention participants. Within-session completeness will be calculated as the percentage of prescribed exercises completed per session, excluding preparation time and skipped items.
Time frame: 12 Weeks
Change in daily physical activity level
To examine the effect of home-based synchronous tele-exercise on daily activity level by using Low Physical activity questionnaire. The questionnaire consists of 11 items that assess various parameters of physical activity within the past 7 days. These parameters include the amount of time spent walking around the neighborhood, for fitness or pleasure, and for transportation purposes, as well as the average duration of sedentary and sitting activities. The questionnaire also calculates the kilocalories expended during light, moderate, vigorous, and total physical activities.
Time frame: Baseline and 12 Weeks
Change in Fried frailty phenotype score
To examine the effect of home-based synchronous tele-exercise on change in Fried frailty phenotype score. Frailty will be assessed using the Fried frailty phenotype, based on five criteria: unintentional weight loss of 10 pounds or more in the prior year by self-report; exhaustion based on responses to two questions about energy; low physical activity based on self-reported frequency of mildly, moderately, and very energetic activity, with low physical activity considered present when both moderately and very energetic activities were reported as occurring hardly ever or never; slow gait speed based on gender- and height-stratified cutoffs; and weak grip strength based on gender- and BMI-stratified cutoffs.
Time frame: Baseline and 12 Weeks
Change in physical function level
To examine the effect of home-based synchronous tele-exercise on physical function level by 6 minute walk test and short physical performance battery test
Time frame: Baseline and 12 Weeks
Plan to share: Yes — Individual participant data (IPD) that underlie the results reported in the published article, after deidentification are to be shared
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Pardis Specialized Wellness Institute