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

Hemodialysis Complication Clinical Trial

Official title:

Interval Versus Continous Intradialytic Training on Muscla Quality Index and Functional Capacity in Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05722496
• Other study ID #: 111118
• Status: Completed
• Phase: N/A
• Start date: January 3, 2023
• Est. completion date: September 10, 2023

Study information

• Verified date: September 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 )

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 )

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 10, 2023
• Est. primary completion date: September 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hemodialysis Complication

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of physical therapy, cairo university	Cairo	Dokki

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle quality index	The MQI was quantified using a timed sit-to-stand test, body mass, and leg length to calculate a power index that is expressed in watts (W). The MQI was calculated as follows: QI (Watts) = ((Leg length×0.4) ×Bodymass×gravity×10) / Time taken for (sit to stand 5 times) Body mass will be measured using a digital scale. Leg length will be taken using tape measure to measure the distance (in meters) from the greater trochanter of the femur to the lateral malleolus, measured from standing position . BY using a stopwatch, sit-to-stand time will be calculated as the time to stand from a seated position and return to sitting consecutively five times. The use of arms not allowed during the sit-to-stand test. Acceleration of gravity (9.8 m/s2).; After measuring leg length, body mass and time for sit to stand, all these data will be written in the previous equation to calculate muscle quality index and expressed in watts (W).	2 months
Primary	six minute walk test	Six minute walk test (6MWT) to assess physical functional capacity (using stopwatch, colored tape to mark starting line and end line of corridor) Using a stopwatch, assess physical functional capability. The 6MWT will be conducted indoors along a 30 m long, level, straight, enclosed hallway, with the length of the corridor indicated with brightly coloured tape at the beginning and end lines. Subjects will be advised to walk as far as possible from end to end of the corridor without jogging or running, and to cover as much distance as feasible in the 6 minute time limit . This test was performed at the beginning of treatment and at the end of treatment program (8 weeks) to assess functional performance difference.	2 months