Amino Acids Supplementation and Exercise Intervention in Hemodialysis Patients

Phase 4

Active, not recruiting

• Conditions: Malnutrition; Hemodialysis Complication
• Interventions: Other: intradialytic exercise; Dietary Supplement: ketoanalogue supplementation

• Registration Number: NCT06452563
• Lead Sponsor: Mansoura University

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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-12
• Status Verified: 2024-06
• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-10
• Last Update Submitted: 2024-06-10
• Study First Posted: 2024-06-11
• Last Update Posted: 2024-06-11
• Primary Completion: 2024-08-15
• Study Completion: 2024-09-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intradialytic exercise group	intradialytic exercise	Participants will be asked to do intradialytic exercise only
Ketoanalogs Supplementation Group	ketoanalogue supplementation	Participants will receive daily a total of six tablets of Ketoanalogs Supplementation divided into three doses for three months .
Ketoanalogs Supplementation and intradialytic exercise group	ketoanalogue supplementation	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 .
Ketoanalogs Supplementation and intradialytic exercise group	intradialytic exercise	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 .

Primary Outcome Measures

Name	Time	Method
Muscle mass	3 months	skeletal muscle mass (SMM) will be assessed using the Inbody test before and after this trial .
The thickness of the quadriceps rectus femoris and quadriceps vastus intermedius	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 .
Muscle function test	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 .

Secondary Outcome Measures

Name	Time	Method
Fatigue score	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

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 El Mansura, Egypt