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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Other: low- to moderate-continuous intensity cycling exercises:; Other: moderate- to high-interval intensity cycling exercises; Other: hemodialysis sessions only

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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11517
    • Faculty of physical therapy - Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	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; Other Names: low- to moderate-continuous aerobic exercise
Active Comparator: 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	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
Sham Comparator: group (C); received the hemodialysis sessions only.	Other: hemodialysis sessions only; hemodialysis sessions only

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2022
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 15, 2023

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 17, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Intradialytic cycling exercise, function capacity, hemodialysis, quality of life.
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency, Chronic
• Other Study ID Numbers: Chronic renal failure

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No