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Active, Not Recruiting

NCT Number: NCT06452563

Amino Acids Supplementation and Exercise Intervention in Hemodialysis Patients

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hemodialysis Complication Behavior Malnutrition Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mansoura University

Al Mansurah, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hemodialysis patients due to chronic kidney diseases
  • Age between 18 - 60

Exclusion criteria

  • Frail patients
  • The patients who refused to participate
  • Growth retarded patients
  • Disabilities

Treatment and study plan

ketoanalogue supplementation

Dietary Supplement

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

Other

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

Primary outcomes

  1. Muscle mass

    Time frame: 3 months

    skeletal muscle mass (SMM) will be assessed using the Inbody test before and after this trial .

  2. Muscle function test

    Time frame: 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 .

  3. The thickness of the quadriceps rectus femoris and quadriceps vastus intermedius

    Time frame: 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 .

Secondary outcomes

  1. Fatigue score

    Time frame: 3 months

    Fatigue score will be measured pre- and post- this trial using the Modified Fatigue Impact Scale (MFIS) . Higher MFIS scores indicate a higher burden of fatigue, and less physical activity, concentration, or motivation, respectively. A subjective fatigue score of ≥35 was defined as severe fatigue

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 11, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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