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

NCT ID: NCT06173141

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2023-04-30

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-seven 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 three patients received the hemodialysis sessions only.

Group A (low- to moderate-continuous intensity cycling exercises:

Twenty three 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 one 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 seven 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.

Conditions

Chronic Kidney Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A (low- to moderate-continuous intensity cycling exercises:

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 Type: ACTIVE_COMPARATOR

low- to moderate-continuous intensity cycling exercises:

Intervention Type: OTHER

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),

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

Group Type: ACTIVE_COMPARATOR

moderate- to high-interval intensity cycling exercises

Intervention Type: OTHER

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

group (C)

received the hemodialysis sessions only.

Group Type: SHAM_COMPARATOR

hemodialysis sessions only

Intervention Type: OTHER

hemodialysis sessions only

Interventions

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

Intervention Type: OTHER

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

Intervention Type: OTHER

hemodialysis sessions only

hemodialysis sessions only

Intervention Type: OTHER

Other Intervention Names

low- to moderate-continuous aerobic exercise

Eligibility Criteria

Inclusion Criteria

1. Sixty-seven 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Heba Ahmed Mousa Galeb

Lecturer at the Department of Physical Therapy for Cardiovascular /Respiratory Disorders and Geriatrics Faculty of Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Physical Therapy - Cairo University

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 31332699 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35246460 (View on PubMed)

Other Identifiers

Chronic renal failure

Identifier Type: -

Identifier Source: org_study_id