Amino Acids Supplementation and Exercise Intervention in Hemodialysis Patients

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06452563
• Other study ID #: R.24.04.2576
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 12, 2024
• Est. completion date: September 15, 2024

Study information

• Verified date: June 2024
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 15, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis Complication
• Malnutrition

Intervention

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

Locations

Country	Name	City	State
Egypt	Mansoura University	El Mansura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle mass	skeletal muscle mass (SMM) will be assessed using the Inbody test before and after this trial .	3 months
Primary	Muscle function test	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 months
Primary	The thickness of the quadriceps rectus femoris and quadriceps vastus intermedius	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 .	3 months
Secondary	Fatigue score	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	3 months