Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 9:07 PM
Study NCT ID:
NCT04898608
Status:
COMPLETED
Last Update Posted:
2023-03-28
First Post:
2021-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Exercise on Dialysis Patients' Survival
Sponsor:
Pardis Specialized Wellness Institute
Organization:
Study Overview
Official Title:
The Effect of Intradialytic Exercise on Dialysis Patients' Survival: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-05
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 purpose of this study is to check if patients' exercise during their dialysis sessions can prevent their early deaths.
Detailed Description:
Dialysis patients suffer from a number of problems, one of which is reduced ability, decreased functional capacity, and consequently reduced physical capability. Forced inactivity due to immobility in dialysis sessions and the need to rest and relieve fatigue for a few hours after each session cause patients to become more inactive day by day, and according to various studies, inactivity in these patients along with reduced physical capabilities increase the risk of cardiovascular disease, which is a risk factor for mortality in these patients.
On the other hand, inactivity is an independent predictor of hospitalization and mortality in these patients.
Studies have shown that exercise can produce many different effects in these patients. However, exercise interventions are often short-term, and even in long-term cases, the aim of studies is only to examine a number of hematological factors or factors such as functional capacity in these patients.
A study is currently being designed to directly evaluate the impact of exercise on patients' survival.
To test this hypothesis, patients do exercise for 6 months during dialysis. And then will be monitored for a year to determine patients' survival.
During 6 months of intervention, hematological parameters, nutrition index and functional capacity of patients are evaluated.
In the analyzes, the survival rate of patients in one year follow-up period is compared between patients who took part in intradialytic sessions (intervention group) and patients who did not do any physical activity during dialysis (control group). In addition, by analyzing the variables measured during the 6 months of the intervention, the effect of exercise on parameters relating to survival is evaluated.
On the other hand, inactivity is an independent predictor of hospitalization and mortality in these patients.
Studies have shown that exercise can produce many different effects in these patients. However, exercise interventions are often short-term, and even in long-term cases, the aim of studies is only to examine a number of hematological factors or factors such as functional capacity in these patients.
A study is currently being designed to directly evaluate the impact of exercise on patients' survival.
To test this hypothesis, patients do exercise for 6 months during dialysis. And then will be monitored for a year to determine patients' survival.
During 6 months of intervention, hematological parameters, nutrition index and functional capacity of patients are evaluated.
In the analyzes, the survival rate of patients in one year follow-up period is compared between patients who took part in intradialytic sessions (intervention group) and patients who did not do any physical activity during dialysis (control group). In addition, by analyzing the variables measured during the 6 months of the intervention, the effect of exercise on parameters relating to survival is evaluated.
Study Oversight
Has Oversight DMC:
True
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?: