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Amino Acids Supplementation and Exercise Intervention in Hemodialysis Patients

NCT06452563 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-09-19

No results posted yet for this 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.

Conditions

  • Hemodialysis Complication
  • Malnutrition

Interventions

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

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-12
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06452563 on ClinicalTrials.gov