Difference Between Interval and Continous Intradialytic Exercise on Functional Capacity in Hemodialysis Patient

NCT ID: NCT05722496

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-03
• Study Completion Date: 2023-09-10

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 )

Conditions

Hemodialysis Complication

Study Design

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

Study Groups

High Intensity Interval Training Group (Group A)

Each training session consist of three parts of 30 minutes:

• Warm up (5 minutes) free active exercise of the lower extremities,
• Training continued with three exercise intervals lasting 3 min each, at an exercise intensity of 85%-95% of HRpeak equalling 15-17 on the Borg scale. Each interval was separated by 4 min of active breaks at an intensity of 60%-70% of HRpeak.
• Cool down (5 minutes) free exercise of lower extremities. Training program will last for 8 weeks with frequency 3times / week.

Group Type: EXPERIMENTAL

Aerobic pedaling exercise

Intervention Type: OTHER

aerobic exercise in the form of leg pedaling exercise in semi-supine position using leg ergometer by different intensities

Moderate intensity continous training group (Group B)

Each training session consist of three parts of 30 minutes:

• Warm up (5 minutes) free active exercise of the lower extremities,
• Training continued with cycling at low-to-moderate exercise intensity of 50%-60% of HRpeak, representing 11-13 on the Borg scale.
• Cool down (5 minutes) free exercise of lower extremities. Training program will last for 8 weeks with frequency 3times / week.

Group Type: EXPERIMENTAL

Aerobic pedaling exercise

Intervention Type: OTHER

aerobic exercise in the form of leg pedaling exercise in semi-supine position using leg ergometer by different intensities

Interventions

Aerobic pedaling exercise

aerobic exercise in the form of leg pedaling exercise in semi-supine position using leg ergometer by different intensities

Intervention Type: OTHER

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).

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hadeer Saber Mansour El-Sayed

assistant lecturer at department of cardiovascular, respiratory and geriatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hala m ezz eldeen, professor

Role: STUDY_DIRECTOR

department of cardiovascular, respiratory and geriatrics disorders

Locations

Faculty of physical therapy, cairo university

Cairo, Dokki, Egypt

Countries

Egypt

Other Identifiers

111118

Identifier Type: -

Identifier Source: org_study_id