Amino Acids Supplementation and Exercise Intervention in Hemodialysis Patients

Mansoura University

Status and phase: Active, not recruiting; Phase 4

Conditions: Hemodialysis Complication; Malnutrition

Treatments: Other: intradialytic exercise; Dietary Supplement: ketoanalogue supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT06452563

R.24.04.2576

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups

Ketoanalogs Supplementation Group

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: ketoanalogue supplementation

Ketoanalogs Supplementation and intradialytic exercise group

Active Comparator group

Description:

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 .

Treatment:

Dietary Supplement: ketoanalogue supplementation

Other: intradialytic exercise

Intradialytic exercise group

Active Comparator group

Description:

Participants will be asked to do intradialytic exercise only

Treatment:

Other: intradialytic exercise

Control group

No Intervention group

Description:

Participants will not receive drug or do exercises