Viewing Study NCT06313892



Ignite Creation Date: 2024-05-06 @ 8:15 PM
Last Modification Date: 2024-10-26 @ 3:24 PM
Study NCT ID: NCT06313892
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-04-22
First Post: 2024-03-10

Brief Title: The Effect of Home Based Tel-Exercise on Dialysis Patients
Sponsor: Pardis Specialized Wellness Institute
Organization: Pardis Specialized Wellness Institute

Study Overview

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
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 worlds 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 technologiesSeveral 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None