The Effect of Exercise on Dialysis Patients' Survival

Pardis Specialized Wellness Institute

Status: Completed

Conditions: Hemodialysis; End Stage Renal Disease; Kidney Disease, Chronic

Treatments: Other: Intradialytic Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04898608

PA20HD-2-01

Details and patient eligibility

About

The purpose of this study is to check if patients' exercise during their dialysis sessions can prevent their early deaths.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

Exercise group

Experimental group

Description:

The patients will participate in intradialytic exercise 3 times a week for 24 weeks.

Treatment:

Other: Intradialytic Exercise

Control group

No Intervention group

Description:

The patients will receive regular care and treatment in every dialysis sessions without any intradialytic exercise.