Clinical trial NCT06173141: Effect of Intradialytic Continuous Versus Interval Aerobic Exercises on Functional Capacity in Patients With Chronic Renal Failure.
Official title: Effect of Intradialytic Continuous Versus Interval Aerobic Exercises on Functional Capacity Quality of Life and in Patients With Chronic Renal Failure.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: Intradialytic cycling exercise, function capacity, hemodialysis, quality of life.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 67
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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) received the hemodialysis sessions only.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Kidney Disease Quality of Life Questionnaire -SF36(KDQoL-SF36)
timeFrame: pre and post treatment after 2 months
Secondary outcomes:
measure: blood urea, serum creatinine
timeFrame: pre and post treatment after 2 months
measure: 6-min walk distance
timeFrame: pre and post treatment after 2 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy - Cairo University
Study officials:
References:
citation: 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.
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.