Clinical trial NCT06787599: The Effect of Home Based Tele-Exercise on Peritoneal Dialysis Patients
Official title: The Effect of Synchronous Homebased Tele-exercise on Physical Function, Daily Physical Activity and Frailty in Peritoneal Dialysis Patients: A Randomized Pilot Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End Stage Renal Disease
Peritoneal Dialysis Complication
Keywords: Tele-exercise
Peritoneal
Dialysis Patients
Frailty
Physical function
Lead sponsor: Pardis Specialized Wellness Institute
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocate to intervention group or control group and will be examined in the same way.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Recruitment rate
timeFrame: 1 Month
measure: Retention rate
timeFrame: 3 Months
measure: Adherence rate
timeFrame: 3 Months
measure: Goal Achievement Scale (GAS)
timeFrame: Pre-test and 3 Months Later (Post-test)
Secondary outcomes:
measure: Rate of changes of daily physical activity level
timeFrame: Pre-test and 3 Months Later (Post-test)
measure: Rate of changes of Frailty level
timeFrame: Pre-test and 3 Months Later (Post-test)
measure: Rate of changes of physical function level
timeFrame: Pre-test and 3 Months Later (Post-test)
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Khorshid Dialysis Center
Study officials:
affiliation: Pardis Specialized Wellness Institute
name: Mohammad Ali Tabibi, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Griffith University
name: Paul Bennett, Prof
role: STUDY_DIRECTOR
affiliation: Pardis Specialized Wellness Institute
name: Farzad Nazemi
role: STUDY_DIRECTOR
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