An interventional study of Intradialytic Exercise in Kidney Disease, Chronic, End Stage Renal Disease and Hemodialysis, sponsored by Pardis Specialized Wellness Institute. Completed at 2 sites in Iran, Islamic Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-03-28.
Sponsored by Pardis Specialized Wellness Institute · Not applicable, Interventional, and Supportive care
The purpose of this study is to check if patients' exercise during their dialysis sessions can prevent their early deaths.
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 74 is close to the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
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Exclusion Criteria:
The patients will participate in intradialytic exercise 3 times a week for 24 weeks.
Other: Intradialytic Exercise
The patients will receive regular care and treatment in every dialysis sessions without any intradialytic exercise.
Participants will do concurrent exercise (a combination of aerobic exercise and resistance training) for 30-60 minutes during the second hour of their routine hemodialysis sessions. To determine the intensity of the prescribed exercise, maximum heart rate is used for aerobic workout and 1RM for resistance protocols. Exercises will be performed at a moderate exercise intensity (12-14 on the Borg RPE Scale). All protocols are tailor-made based on each individual's needs and physical abilities.
1-year Survival of dialysis patients
Mortality data is gathered using form "CMS-2746" which is specifically for dialysis patients.
Time frame: Follow-up phase (1- year)
Rate of changes of Albumin for 6 months
Time frame: Pre_test and every 3 months for 6 months
Rate of changes of Hemoglobin for 6 months
Time frame: Pre_test and every 3 months for 6 months
Rate of changes of Hematocrit for 6 months
Time frame: Pre_test and every 3 months for 6 months
Rate of changes of Red Blood Cells for 6 months
Time frame: Pre_test and every 3 months for 6 months
Rate of changes of Calcium for 6 months
Time frame: Pre_test and every 3 months for 6 months
Rate of changes of Phosphorus for 6 months
Time frame: Pre_test and every 3 months for 6 months
Rate of changes of Parathyroid Hormone for 6 months
Time frame: Pre_test and every 3 months for 6 months
Changes of GNRI for 6 months
The Geriatric Nutritional Risk Index (GNRI) is a screening method that was primarily developed to identify older patients with malnutrition. It consists of serum albumin levels as well as body weight measurements. GNRI is associated with an increasing risk of long-term all-cause mortality in prevalent hemodialysis patients, even after adjusting for age and comorbidity
Time frame: Pre_test and every 3 months for 6 months
Changes of the meters walked during the 6MWT for 6 months
Six-minute walk test (6MWT) is a walking endurance assessment measured in meters of total distance completed over 6 minutes
Time frame: Pre_test and every 3 months for 6 months
Plan to share: Yes — Individual participant data that underlie the results reported in the published article, after deidentification are to be shared.
Supporting information: Study protocol, Sap
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Pardis Specialized Wellness Institute