Effect of Intradialytic Continuous Versus Interval Aerobic Exercises on Quality of Life in Patients With Chronic Renal Failure.

Study Overview
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Brief Summary
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Chronic kidney disease has emerged as one of the leading causes of mortality worldwide, and it is one of a small number of non-communicable diseases that have shown an increase in associated deaths over the past 2 decades. The high number of affected individuals and the significant adverse impact of chronic kidney disease should prompt enhanced efforts for better prevention and treatment. Chronic kidney disease is a serious medical problem, as it is associated with high risks of complications which lead to poor quality of life and physical capacity.

Detailed Description
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Sixty-four patients undergoing haemodialysis randomly be allocated into three groups, (A, B & C). Group A (low- to moderate-continuous intensity cycling exercises, group B (moderate- to high-interval intensity cycling exercises), the exercises performed two sessions per week for two months and group (C)Twenty two patients received the hemodialysis sessions only. Group A (low- to moderate-continuous intensity cycling exercises: Twenty two patients performed aerobic exercise during dialysis using Pedal machine at low- to moderate continuous intensity rating from 11 to 13 on the Borg scale for 15-30 minutes. warming up and cool down (approximately 10 minutes) in form of free active exercise of the lower extremities. Group B (moderate- to high-interval intensity cycling exercises), Twenty patients performed aerobic exercise during dialysis using Pedal machine at moderate-to-high interval intensity rating from 12 to 15 on the Borg scale for 15-30 minutes. warming up and cool down (approximately 10 minutes) in form of free active exercise of the lower extremities. Inclusion Criteria: Sixty four patients of both sexes Age will range from 35-55 years old. BMI will be from 25-34.5 Kg/m2. All patients with stage 5 of CRF. All patients are stable on dialysis for at least six months before the study. Stable medical and clinical hemodynamic state. Exclusion criteria: Patients with hearing impairment or mental disorder. Patients with unstable angina, uncontrolled cardiac arrhythmia, decompensated heart failure, persistent systolic blood pressure (BP) greater than 200 mmHg, persistent diastolic BP greater than 120 mmHg, acute pericarditis or myocarditis. Patients with auto-immune diseases. Chronic inflammatory orthopedic disorders and rheumatoid arthritis. Patients with history of neuromuscular disease (muscular dystrophy, myasthenia gravis, myopathy, multiple sclerosis and peripheral neuropathy). Patients with chronic obstructive lung disease, restrictive lung disease or chronic chest infection. Patients with BMI > 35Kg/m2.

Official Title
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Effect of Intradialytic Continuous Versus Interval Aerobic Exercises on Functional Capacity Quality of Life and in Patients With Chronic Renal Failure.

Conditions
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Chronic Kidney Diseases

Intervention / Treatment
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* Other: low- to moderate-continuous intensity cycling exercises:
* Other: moderate- to high-interval intensity cycling exercises
* Other: hemodialysis sessions only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sixty-four patients of both sexes Age will range from 35-55 years old. BMI will be from 25-34.5 Kg/m2. All patients with stage 5 of CRF. All patients are stable on dialysis for at least six months before the study. Stable medical and clinical hemodynamic state. Exclusion Criteria: 1. Patients with hearing impairment or mental disorder. 2. Patients with unstable angina, uncontrolled cardiac arrhythmia, decompensated heart failure, persistent systolic blood pressure (BP) greater than 200 mmHg, persistent diastolic BP greater than 120 mmHg, acute pericarditis or myocarditis. 3. Patients with auto-immune diseases. 4. Chronic inflammatory orthopedic disorders and rheumatoid arthritis. 5. Patients with history of neuromuscular disease (muscular dystrophy, myasthenia gravis, myopathy, multiple sclerosis and peripheral neuropathy). 6. Patients with chronic obstructive lung disease, restrictive lung disease or chronic chest infection. 7. Patients with BMI > 35Kg/m2.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Sixty-four patients undergoing haemodialysis randomly be allocated into three groups, (A, B & C). Group A (low- to moderate-continuous intensity cycling exercises, group B (moderate- to high-interval intensity cycling exercises), the exercises performed two sessions per week for two months and group (C) received the hemodialysis sessions only.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A (low- to moderate-continuous intensity cycling exercises:<br>Patients performed aerobic exercise during dialysis using Pedal machine at low- to moderate continuous intensity rating from 11 to 13 on the Borg scale for 15-30 minutes. warming up and cool down (approximately 10 minutes) in form of free active exercise of the lower extremities | Other: low- to moderate-continuous intensity cycling exercises:<br>* aerobic exercise during dialysis using Pedal machine at low- to moderate continuous intensity rating from 11 to 13 on the Borg scale for 15-30 minutes. warming up and cool down (approximately 10 minutes) in form of free active exercise of the lower extremities<br>* Other names: low- to moderate-continuous aerobic exercise;|
| Active Comparator: Group B (moderate- to high-interval intensity cycling exercises),<br>Patients performed aerobic exercise during dialysis using Pedal machine at moderate-to-high interval intensity rating from 12 to 15 on the Borg scale for 15-30 minutes. warming up and cool down (approximately 10 minutes) in form of free active exercise of the lower extremities | Other: moderate- to high-interval intensity cycling exercises<br>* aerobic exercise during dialysis using Pedal machine at moderate-to-high interval intensity rating from 12 to 15 on the Borg scale for 15-30 minutes. warming up and cool down (approximately 10 minutes) in form of free active exercise of the lower extremities<br>|
| Sham Comparator: group (C)<br>received the hemodialysis sessions only. | Other: hemodialysis sessions only<br>* hemodialysis sessions only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney Disease Quality of Life Questionnaire -SF36(KDQoL-SF36) | The KDQOL™-36 contains 5 subscales: The Physical Component Summary (PCS), Mental Component Summary (MCS), Burden of Kidney Disease (BKD), Symptoms and Problems of Kidney Disease (SPKD), and Effects of Kidney Disease (EKD). The first 2 subscales are a generic measure of HRQOL (and are identical to the SF-12), whereas the last 3 assess issues specific to patients with ESRD or earlier stages of chronic kidney disease. | pre and post treatment after 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood urea, serum creatinine | Blood samples are drawn from the arterial side of the hemodialysis access immediately prior to hemodialysis. Blood sample must be drawn before dialysis is started to prevent this sample from reflecting any impact of dialysis. pre and post kitz blood samples were sent to benha university hospital laboratory for estimating blood urea and creatinine. | pre and post treatment after 2 months | 
| 6-min walk distance | 6min walk test carried out before and after the intervention to determine patient physical functional capacity. According to the American Thoracic Society ,Guidelines for the Six-Minute Walk Test (ATS .2002). | pre and post treatment after 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intradialytic cycling exercise, function capacity, hemodialysis, quality of life.