An interventional study of Home-based Tele Exercise in End Stage Renal Disease and Peritoneal Dialysis 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
Brief Summary:
The objective of the trial is to assess the effect of synchronous home-based tele exercise on daily activity level, functional status and frailty level in Peritoneal Dialysis patients.
Condition or disease Intervention/treatment End Stage Renal Disease Peritoneal Dialysis Complication Behavioral: Home-based Tele Exercise
Patients with renal failure undergoing peritoneal dialysis (PD) therapy typically have very low levels of physical activity (PA), and this is associated with greatly increased morbidity and mortality. Although PD prevents premature death of patients, it can lead to many complications. During the years of treatment, they suffer from various problems such as malnutrition, reduced physical performance, reduced aerobic capacity, low quality of life and inactivity, so that the activity level physical activity of these patients is significantly lower than that of healthy people.
According to studies, regular exercise is beneficial for patients at all stages of renal disease, and the current recommendations for the prevention and management of side effects in PD patients, especially in the elderly, is regular exercise because it improves physical performance and PA.
There are several barriers to participation in PA for people with chronic kidney disease (CKD), especially those who are undergoing PD treatment that prevent them from adopting a consistent exercise program. These include issues specific to PD such as the risk of peritonitis, the need for aseptic technique during bag changes, and the physical discomfort associated with carrying dialysate. Personal issues that prevent participation in PA include lack of knowledge about appropriate exercise and its benefits, and lack of energy or motivation.
To increase activity levels, clinicians and researchers have experimented with different types of interventions, including home-based exercise programs, which are a suitable option for PD 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 by a coach. 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. Tele rehabilitation consultations may include diagnosis, assessment, education, therapy, goal setting, and monitoring. Literature reviews on telerehabilitation practices in the older people have shown that tele-rehabilitation can produce results similar to face-to-face methods.
Communication between patients and rehabilitation specialists takes place through a variety of synchronous approaches such as telephony, internet-based video conferencing, or asynchronous methods like video-based exercise. E-Health interventions utilizing some of these techniques to support prostate, colorectal, breast and leukemia cancer populations have already been trialed with good effects in terms of improved PA levels and reduced sedentary behavior. Several studies have reported the use of eHealth-based self-management interventions in CKD 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 PD 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 PD patient.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's enrollment of 30 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Pardis Specialized Wellness Institute is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The participants (n = 15) in the study group will be given an online personalized exercise program at home in non-peritoneal dialysis (PD). 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 non-peritoneal dialysis (PD) days. Synchronous tele-exercise will be delivered using the free teleconference application (app) (Google Meets software). The groups of teleexercises 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 by eligible number/enrolled number
Time frame: 1 Month
Retention rate
Determining retention rate by patients who completed visit 2 / recruited patients
Time frame: 3 Months
Adherence rate
Determining the adherence by the number of participation in exercise sessions by a participant / the number of the exercise sessions planned in the program
Time frame: 3 Months
Goal Achievement Scale (GAS)
Using GAS to individually evaluate the effect of the intervention, accounting for differences in disease stages and personalized goals.
Time frame: Pre-test and 3 Months Later (Post-test)
Rate of changes of 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: Pre-test and 3 Months Later (Post-test)
Rate of changes of Frailty level
To examine the effect of home-based synchronous tele-exercise on daily activity level by using Fried Frailty Index. Patients will be considered frail if they met 3 or more of the following 5 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 the Minnesota questionnaire (\< 383 kcal/wk for men or \< 270 kcal/wk for women); slow gait speed (based on gender- and height-stratified cutoffs); and weak grip strength (based on gender- and BMI-stratified cutoffs). Patients will be asked whether they are independent in the following activities of daily living (ADLs): bathing, dressing, getting in and out of a chair, and walking around their home or apartment. Those reporting dependency in one or more will be considered to have an ADL limitation.
Time frame: Pre-test and 3 Months Later (Post-test)
Rate of changes of 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: 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, Statistical analysis plan
Time frame: The data will be available after the paper is published. No end date
Access criteria: Not applicable. It will be accessible for public.
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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Pardis Specialized Wellness Institute