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

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06173141
• Other study ID #: Chronic renal failure
• Status: Completed
• Phase: N/A
• Start date: April 30, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: December 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 30, 2023
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Other:
• low- to moderate-continuous intensity cycling exercises:
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
• moderate- to high-interval intensity cycling exercises
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
• hemodialysis sessions only
hemodialysis sessions only

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy - Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Pei G, Tang Y, Tan L, Tan J, Ge L, Qin W. Aerobic exercise in adults with chronic kidney disease (CKD): a meta-analysis. Int Urol Nephrol. 2019 Oct;51(10):1787-1795. doi: 10.1007/s11255-019-02234-x. Epub 2019 Jul 22. — View Citation

Wulczyn KE, Zhao SH, Rhee EP, Kalim S, Shafi T. Trajectories of Uremic Symptom Severity and Kidney Function in Patients with Chronic Kidney Disease. Clin J Am Soc Nephrol. 2022 Apr;17(4):496-506. doi: 10.2215/CJN.13010921. Epub 2022 Mar 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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