The Effect of Exercise on Dialysis Patients' Survival
- Conditions
- Kidney Disease, ChronicEnd Stage Renal DiseaseHemodialysis
- Interventions
- Other: Intradialytic Exercise
- Registration Number
- NCT04898608
- Lead Sponsor
- Pardis Specialized Wellness Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
- Dialysis history ≥ 1 year
- Without myocardial infarction within past 3 months
- Regular dialysis 3 times a week
- Ability to consent
- Doctor's consent
- Unstable cardiac status (angina, decompensated congestive heart failure, severe arteriovenous stenosis, uncontrolled arrhythmias, etc.)
- Active infection or acute medical illness
- Hemodynamic instability
- Labile glycemic control
- Unable to exercise (lower extremity amputation with no prosthesis)
- having severe musculoskeletal pain at rest or with minimal activity
- Unable to sit, stand or walk unassisted (walking device such as cane or walker allowed)
- Having shortness of breath at rest or with activities of daily living (NYHA Class IV)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise group Intradialytic Exercise The patients will participate in intradialytic exercise 3 times a week for 24 weeks.
- Primary Outcome Measures
Name Time Method 1-year Survival of dialysis patients Follow-up phase (1- year) Mortality data is gathered using form "CMS-2746" which is specifically for dialysis patients.
- Secondary Outcome Measures
Name Time Method Rate of changes of Calcium for 6 months Pre_test and every 3 months for 6 months Changes of GNRI for 6 months Pre_test and every 3 months 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
Rate of changes of Albumin for 6 months Pre_test and every 3 months for 6 months Rate of changes of Parathyroid Hormone for 6 months Pre_test and every 3 months for 6 months Rate of changes of Hemoglobin for 6 months Pre_test and every 3 months for 6 months Rate of changes of Hematocrit for 6 months Pre_test and every 3 months for 6 months Rate of changes of Phosphorus for 6 months Pre_test and every 3 months for 6 months Changes of the meters walked during the 6MWT for 6 months Pre_test and every 3 months for 6 months Six-minute walk test (6MWT) is a walking endurance assessment measured in meters of total distance completed over 6 minutes
Rate of changes of Red Blood Cells for 6 months Pre_test and every 3 months for 6 months
Trial Locations
- Locations (2)
Abolfazl medical center
🇮🇷Isfahan, Iran, Islamic Republic of
Pardis specialized wellness institute
🇮🇷Isfahan, Iran, Islamic Republic of