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Completed

NCT Number: NCT06787599

The Effect of Home Based Tele-Exercise on Peritoneal Dialysis Patients

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years and over
  • At least 3 months of stable peritoneal dialysis (PD) history
  • Permission from their doctors
  • Have decision-making capacity to enable them to give informed consent to take part in the study
  • Have access to a smart device (e.g., smartphone, laptop or tablet), and have internet access

Exclusion criteria

  • Unstable cardiac status, including angina, decompensated congestive heart failure, or uncontrolled arrhythmias
  • Active infection or acute medical illness
  • Hemodynamic instability
  • Labile glycemic control
  • Individuals unable to exercise entirely, e.g., lower extremity amputations without feasible alternatives for adapted exercise
  • Having severe musculoskeletal pain at rest or with minimal activity
  • Unable to sit, stand or walk unassisted (walking device such as cane or walker allowed)
  • Having shortness of breath at rest or with activities of daily living (NYHAClass IV)
  • Individuals with exercise participation ≥ 3 times per week that addressed ≥ 2 of the domains
  • Myocardial infarction within the past 3 months

Treatment and study plan

Home-based Tele Exercise

Behavioral

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.

Primary outcomes

  1. Recruitment rate

    Time frame: 1 Month

    Determining recruitment by eligible number/enrolled number

  2. Retention rate

    Time frame: 3 Months

    Determining retention rate by patients who completed visit 2 / recruited patients

  3. Adherence rate

    Time frame: 3 Months

    Determining the adherence by the number of participation in exercise sessions by a participant / the number of the exercise sessions planned in the program

  4. Goal Achievement Scale (GAS)

    Time frame: Pre-test and 3 Months Later (Post-test)

    Using GAS to individually evaluate the effect of the intervention, accounting for differences in disease stages and personalized goals.

Secondary outcomes

  1. Rate of changes of daily physical activity level

    Time frame: Pre-test and 3 Months Later (Post-test)

    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.

  2. Rate of changes of Frailty level

    Time frame: Pre-test and 3 Months Later (Post-test)

    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.

  3. Rate of changes of physical function level

    Time frame: Pre-test and 3 Months Later (Post-test)

    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

Sponsors and collaborators

Lead sponsor

Pardis Specialized Wellness Institute

Other

Registry information

Official study title

The Effect of Synchronous Homebased Tele-exercise on Physical Function, Daily Physical Activity and Frailty in Peritoneal Dialysis Patients: A Randomized Pilot Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 22, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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