The Effect of Intradialytic Exercise on Dialysis Patients' Survival: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Kidney Disease, Chronic
- Sponsor
- Pardis Specialized Wellness Institute
- Enrollment
- 74
- Locations
- 2
- Primary Endpoint
- 1-year Survival of dialysis patients
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Dialysis history ≥ 1 year
- •Without myocardial infarction within past 3 months
- •Regular dialysis 3 times a week
- •Ability to consent
- •Doctor's consent
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
1-year Survival of dialysis patients
Time Frame: Follow-up phase (1- year)
Mortality data is gathered using form "CMS-2746" which is specifically for dialysis patients.
Secondary Outcomes
- 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)
- 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)
- Rate of changes of Red Blood Cells for 6 months(Pre_test and every 3 months for 6 months)