The Effect of Home Based Tel-Exercise on Dialysis Patients

Pardis Specialized Wellness Institute

Status: Completed

Conditions: Hemodialysis Complication; End Stage Renal Disease

Treatments: Behavioral: Home based Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06313892

PA24HD-2-05

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. being Aged 18 years and over
2. Regular in-center HD 3 times a week
3. completed at least 1 year of stable HD history
4. Without myocardial infarction within past 3 months
5. permission from their doctors
6. have decision making capacity to enable them to give informed consent to take part in the study
7. have access to a smart device (e.g. smart phone, laptop or tablet), and have internet access

Exclusion criteria

1. Unstable cardiac status (angina, decompensated congestive heart failure, severe arteriovenous stenosis, uncontrolled arrhythmias, etc.) 2) Active infection or acute medical illness 3) Hemodynamic instability 4) Labile glycemic control 5) Unable to exercise (lower extremity amputation with no prosthesis) 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) Unstable HD treatment and changing (titrating) medication regime 11) Excess inter-dialytic weight gain (>4 kg since last HD or exercise session) 12) Myocardial infarction within past 3 months

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Exercise group

Experimental group

Description:

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.

Treatment:

Behavioral: Home based Exercise

Control group

No Intervention group

Description:

Patients allocated to the control group 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.