Hemodialysis Complication, Malnutrition
Conditions
Keywords
haemodialysis patients, ketoanalogs, malnutrition, exercise, Muscle function
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.
Interventions
DIETARY_SUPPLEMENTketoanalogue 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
low-intensity exercise training composed of knee extension and hip abduction and flexion from a three-repetition maximum (3RM) using ankle weights
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle mass | 3 months | skeletal muscle mass (SMM) will be assessed using the Inbody test before and after this trial . |
| 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 . |
| 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 . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed