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

NCT06173141 | Completed

• 1 other identifier: Chronic renal failure
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Keywords

Intradialytic cycling exercise, function capacity, hemodialysis, quality of life.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• blood urea, serum creatinine

  pre and post treatment after 2 months

• 6-min walk distance

  pre and post treatment after 2 months

Study Arms (3)

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

ACTIVE COMPARATOR

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:

Group B (moderate- to high-interval intensity cycling exercises),

ACTIVE COMPARATOR

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

group (C)

SHAM COMPARATOR

received the hemodialysis sessions only.

Other: hemodialysis sessions only

Interventions

low- to moderate-continuous intensity cycling exercises: 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

Also known as: low- to moderate-continuous aerobic exercise

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

moderate- to high-interval intensity cycling exercises 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 B (moderate- to high-interval intensity cycling exercises),

hemodialysis sessions only OTHER

hemodialysis sessions only

group (C)

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Sixty-seven 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.

You may not qualify if:

• \. 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.
• \. 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).
• \. Patients with chronic obstructive lung disease, restrictive lung disease or chronic chest infection.
• \. Patients with BMI \> 35Kg/m2.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy - Cairo University

Cairo, 11517, Egypt

Location

Related 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.

  PMID: 31332699 BACKGROUND

• 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.

  PMID: 35246460 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single (participant)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer at the Department of Physical Therapy for Cardiovascular /Respiratory Disorders and Geriatrics Faculty of Physical Therapy

Model Details: 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) received the hemodialysis sessions only.

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: April 30, 2022
• Primary Completion: October 30, 2022
• Study Completion: April 30, 2023
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

EG (1)