Amino Acids Supplementation and Exercise Intervention in Hemodialysis Patients

NCT06452563 | Active Not Recruiting Phase 4

• 1 other identifier: R.24.04.2576
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 1.A group that will be only taking AAs supplementation
2. 2.A group taking AAs supplementation along with intradialytic exercise
3. 3.A group only performing intradialytic exercise
4. 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

Keywords

haemodialysis patients; ketoanalogs; malnutrition; exercise; Muscle function

Outcome Measures

Primary Outcomes (3)

• Muscle mass

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

  3 months

• 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

• 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 Outcomes (1)

• Fatigue score

  3 months

Study Arms (4)

Ketoanalogs Supplementation Group

ACTIVE COMPARATOR

Participants will receive daily a total of six tablets of Ketoanalogs Supplementation divided into three doses for three months .

Dietary Supplement: ketoanalogue supplementation

Ketoanalogs Supplementation and intradialytic exercise group

ACTIVE COMPARATOR

Participants will receive daily a total of six tablets of Ketoanalogs Supplementation divided into three doses for three months in addition to doing intradialytic exercise .

Dietary Supplement: ketoanalogue supplementation; Other: intradialytic exercise

Intradialytic exercise group

ACTIVE COMPARATOR

Participants will be asked to do intradialytic exercise only

Other: intradialytic exercise

Control group

NO INTERVENTION

Participants will not receive drug or do exercises

Interventions

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

Ketoanalogs Supplementation Group; Ketoanalogs Supplementation and intradialytic exercise group

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

Intradialytic exercise group; Ketoanalogs Supplementation and intradialytic exercise group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Malnutrition; Motor Activity

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Of Nephrology

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 11, 2024
• Study Start: May 12, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)