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

Not Applicable

Completed

• Conditions: Chronic Kidney Diseases
• Interventions: Other: hemodialysis sessions only; Other: moderate- to high-interval intensity cycling exercises

• Registration Number: NCT06173141
• Lead Sponsor: Cairo University

Brief Summary

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

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:

1. Sixty four patients of both sexes

2. Age will range from 35-55 years old.

3. BMI will be from 25-34.5 Kg/m2.

4. All patients with stage 5 of CRF.

5. All patients are stable on dialysis for at least six months before the study.

6. 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.

Study Timeline

• Study Start: 2022-04-30
• Primary Completion: 2022-10-30
• Study Completion: 2023-04-30
• Status Verified: 2023-12
• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-07
• Last Update Submitted: 2023-12-07
• Study First Posted: 2023-12-15
• Last Update Posted: 2023-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. Sixty-four patients of both sexes
2. Age will range from 35-55 years old.
3. BMI will be from 25-34.5 Kg/m2.
4. All patients with stage 5 of CRF.
5. All patients are stable on dialysis for at least six months before the study.
6. Stable medical and clinical hemodynamic state.

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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.

  2. 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).

  3. Patients with chronic obstructive lung disease, restrictive lung disease or chronic chest infection.

  4. Patients with BMI > 35Kg/m2.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group (C)	hemodialysis sessions only	received the hemodialysis sessions only.
Group B (moderate- to high-interval intensity cycling exercises),	moderate- to high-interval intensity cycling exercises	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

Primary Outcome Measures

Name	Time	Method
Kidney Disease Quality of Life Questionnaire -SF36(KDQoL-SF36)	pre and post treatment after 2 months	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.

Secondary Outcome Measures

Name	Time	Method
blood urea, serum creatinine	pre and post treatment after 2 months	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.
6-min walk distance	pre and post treatment after 2 months	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).

Trial Locations

Locations (1)

Faculty of Physical Therapy - Cairo University; 🇪🇬 Cairo, Egypt