Clinical trial NCT05722496: Difference Between Interval and Continous Intradialytic Exercise on Functional Capacity in Hemodialysis Patient
Official title: Interval Versus Continous Intradialytic Training on Muscla Quality Index and Functional Capacity in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis Complication
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 60
Sex: MALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be assigned randomly by computerized block randomization into two groups:Group (A): 30 patients aged between 45 - 55 years old will participate in 8 weeks of aerobic exercise in the form of high intensity interval training (HIIT) intradialytic pedaling exercise plus hemodialysis (3 sessions per week).

Group (B): 30 patients aged between 45- 55 years old will participate in 8 weeks of aerobic exercise in the form of moderate intensity continous training (MICT) intradialytic pedaling exercise plus hemodialysis (3 sessions per week).
Primary purpose: TREATMENT

Brief summary: The goal of this study is to find out the effect of interval versus continous intradialytic training on muscle quality index and functional capacity in Hemodialysis patients. The main question it aims to answer is:

Does interval versus continous intradialytic training have an effect on muscle quality index and functional capacity in hemodialysis patients? Patients will be assigned randomly by computerized block randomization into two groups:Group (A): 30 patients will participate in 8 weeks of aerobic exercise in the form of high intensity interval training (HIIT) intradialytic pedaling exercise plus hemodialysis (3 sessions per week).Group (B): 30 patients will participate in 8 weeks of aerobic exercise in the form of moderate intensity continous training (MICT) intradialytic pedaling exercise plus hemodialysis (3 sessions per week) . primary and secondary variables will be measured before starting treatment and after completion (after 2 months )

Detailed description: Individuals with CKD (both predialysis and ESRD) may be at greater risk of sarcopenia given the combined reductions in physical function, skeletal muscle performance and skeletal muscle mass.

Study include sixty male patients on hemodialysis for 1-3 years aged from 45 to 55 years old selected from hemodialysis unit at National Institute of Urology and Nephrology. Before starting treatment , patients will fill consent form and the study aims and procedure will be explained to each patient . study include Sixty male patients on hemodialysis for 1-3 years aged from 45 to 55 years old selected from hemodialysis unit at National Institute of Urology and Nephrology. Patients will be assigned randomly by computerized block randomization into two groups:Group (A): 30 patients will participate in 8 weeks of aerobic exercise in the form of high intensity interval training (HIIT) intradialytic pedaling exercise plus hemodialysis (3 sessions per week).Group (B): 30 patients will participate in 8 weeks of aerobic exercise in the form of moderate intensity continous training (MICT) intradialytic pedaling exercise plus hemodialysis (3 sessions per week) Karvonen formula will be used to calculate training heart rate THR= RHR+ (HRmax - RHR) 65%-80% AS HRmax = 220-Age patients of HIIT will perform aerobic exercise in the form of leg pedaling exercise in semi-supine position using leg ergometer at high intensity 85%-95% of HRpeak with 4 min of active breaks at an intensity of 60%-70% of HRpeak. . Exercise will be done at the first 2 hours of dialysis (to avoid dialysis hypotension episodes).

patients of MICT will perform aerobic exercise in the form of leg pedaling exercise in semi-supine position using leg ergometer at moderate intensity 50%-60% of HRpeak . Exercise will be done at the first 2 hours of dialysis (to avoid dialysis hypotension episodes).

primary and secondary variables will be measured before starting treatment and after completion (after 2 months )

Eligibility criteria: Inclusion Criteria:

1. Age between 45- 55 years.
2. Male sex included.
3. Patients with grade 5 chronic renal failure on hemodialysis.
4. Patients are on hemodialysis for 1-3 years.
5. Body mass index (BMI) range from 25-34.9 Kg/m2.
6. They will be medically and psychologically stable.
7. Receiving their physician-prescribed pharmacotherapy regularly.
8. Agree to participate by signing an informed consent form.

Exclusion Criteria:

1. Inability to comprehend and follow instructions as in dementia or speech problems such as dysphasia.
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. Acute systemic infection.
4. Presence of malignant disease.
5. Patients with Diabetes Mellitus.
6. Patients with Lupus Nephritis.
7. Patients with chronic obstructive lung disease, restrictive lung disease or chronic chest infection.
8. Severe obesity (BMI \> 35).
9. Chronic inflammatory orthopedic disorders and rheumatoid arthritis.
10. Patients with muscle injuries or neuromuscular disorders (muscular dystrophy, myasthenia gravis, myopathy, multiple sclerosis and peripheral neuropathy).

Primary outcomes:
measure: muscle quality index
timeFrame: 2 months
measure: six minute walk test
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of physical therapy, cairo university
state: Dokki
Study officials:
affiliation: department of cardiovascular, respiratory and geriatrics disorders
name: hala m ezz eldeen, professor
role: STUDY_DIRECTOR
References: