End Stage Renal Disease, Hemodialysis, Kidney Disease, Chronic
Conditions
Keywords
mortality, exercise during dialysis, physical function, sarcopenia, hematological parameters
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.
Interventions
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.
Sponsors
Pardis Specialized Wellness Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The lab tech will be blind to whether the sample under evaluation belongs to the intervention group or the control group. A research project collaborator who is not informed about grouping of participants will obtain outcome measurements of the functional test. Outcome adjudicators, and data analysts will be kept blinded to the allocation. Moreover, all investigators, staff, and participants will be kept masked to outcome measurements and trial results.
Intervention model description
Participants will be randomly allocate to intervention group or control group and will be examined in the same way.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 Red Blood Cells for 6 months | Pre_test and every 3 months for 6 months | — |
| Rate of changes of Calcium 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 | — |
| 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 |
| 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 Phosphorus for 6 months | Pre_test and every 3 months for 6 months | — |
Countries
Iran
Outcome results
None listed