Amino Acids Supplementation and Exercise Intervention in Hemodialysis Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

ketoanalogue supplementation: This drug contains 5 essential amino acids (L-lysine monoacetate 75mg, L-threonine 53mg, L-tryptophan 23mg, L-histidine 38mg and L-tyrosine 30mg) and 5 essential amino acid substitutes in the form of calcium salts, including 4 keto-analogues (keto-isoleucine, keto-leucine, keto-valine, and keto-phenylalanine) and a hydroxy-analogue (hydro methionine) as calcium salt . The drug is approved by the Egyptian Drug Authority (EDA) with registration number 34677/2021

intradialytic exercise: low-intensity exercise training composed of knee extension and hip abduction and flexion from a three-repetition maximum (3RM) using ankle weights

Study summary

The goal of this randomized clinical trial is to observe the effect of Amino acids (AAs)supplementation and exercises in haemodialysis patients . The main question it aims to answer is :

Does AAs supplementation and regular exercises have an effect on the muscle mass and function in haemodialysis patients ? Participants will receive daily a total of six tablets of amino acids supplementation divided into three doses. And some Participants will also be asked to do intradialytic exercise.

Researchers will compare the effects of these interventions on the muscle mass and fatigue, among four groups:

1. A group that will be only taking AAs supplementation
2. A group taking AAs supplementation along with intradialytic exercise
3. A group only performing intradialytic exercise
4. A passive control group This will be monitored through BMI, anthropometric measures, Musculoskeletal ultrasound assessment of the quadriceps muscle , fatigue questionnaires and sit and stand test.

Eligibility

Primary outcome measure(s)

• Muscle mass — 3 months
  skeletal muscle mass (SMM) will be assessed using the Inbody test before and after this trial .
• Muscle function test — 3 months
  The muscle function will be assessed by the Sit-to-Stand Test (STS) . The test is comprised of counting the maximum number of times that the subject is able to stand up unassisted or assisted from a chair in 30 seconds .
• The thickness of the quadriceps rectus femoris and quadriceps vastus intermedius — 3 months
  The thickness of the quadriceps rectus femoris (QRFT) and quadriceps vastus intermedius (QVIT) will be assessed before and after this trial using Ultrasonography. The measurements will be conducted in a standardized manner at two specific landmarks: the midpoint and the border between the lower third and upper two-thirds between the superior anterior iliac spine and the upper pole of the patella .

Trial sites (1)

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