Clinical trial NCT06313892: The Effect of Home Based Tel-Exercise on Dialysis Patients
Official title: The Effect of Synchronous Home Based Tele Exercise on Physical Function, Daily Physical Activity and Frailty in Dialysis Patients: A Randomized Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Hemodialysis Complication
Keywords: Inactivity
Tele exercise
Home based exercise
Hemodialysis
Frailty
Physical function
Lead sponsor: Pardis Specialized Wellness Institute
Sponsor class: OTHER
First posted: 2024-03-15
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: 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.

Detailed 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.

Eligibility criteria: 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

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Primary outcomes:
measure: Recruitment rate
timeFrame: 1 Month
measure: Retention rates
timeFrame: 3 Months
measure: Adherence rate
timeFrame: 3 Months
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
city: Isfahan
country: Iran, Islamic Republic of
facility: Pardis specialized wellness institute
Study officials:
affiliation: Pardis Specialized Wellness Institute
name: Mohammad Ali Tabibi, Dr
role: STUDY_DIRECTOR
affiliation: School of Health Sciences, Western Sydney University, Campbelltow, NSW 2560, Australia
name: Bobby Cheema, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Diabetes Research Centre, University of Leicester, Leicester, UK
name: Tomas Wilkinson, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Nutritional Sciences and Wellness, Arizona University
name: Kenneth Wilund, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Neuroscience and Rehabilitation, University of Ferrara
name: Fabio Manferedini, Dr
role: PRINCIPAL_INVESTIGATOR
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