NCT06452563

Amino Acids Supplementation and Exercise Intervention in Hemodialysis Patients

Amino Acids Supplementation and Exercise Intervention in Hemodialysis Patients: Effects on Muscle and Fatigue - a Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemodialysis Complication
• Malnutrition

Interventions

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

Timeline

• Start date: 2024-05-12
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2024-06-11
• Last updated: 2024-09-19

Locations

1 site across 1 country: Egypt