Amino Acids Supplementation and Exercise Intervention in Hemodialysis Patients
NCT ID: NCT06452563
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2024-05-12
2024-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ketoanalogs Supplementation Group
Participants will receive daily a total of six tablets of Ketoanalogs Supplementation divided into three doses for three months .
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
Ketoanalogs Supplementation and intradialytic exercise group
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 .
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
intradialytic exercise
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
Participants will be asked to do intradialytic exercise only
intradialytic exercise
low-intensity exercise training composed of knee extension and hip abduction and flexion from a three-repetition maximum (3RM) using ankle weights
Control group
Participants will not receive drug or do exercises
No interventions assigned to this group
Interventions
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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
intradialytic exercise
low-intensity exercise training composed of knee extension and hip abduction and flexion from a three-repetition maximum (3RM) using ankle weights
Eligibility Criteria
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Inclusion Criteria
* Age between 18 - 60
Exclusion Criteria
* The patients who refused to participate
* Growth retarded patients
* Disabilities
18 Years
60 Years
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Emad Magdy
Associate Professor Of Nephrology
Locations
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Mansoura University
Al Mansurah, , Egypt
Countries
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Other Identifiers
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R.24.04.2576
Identifier Type: -
Identifier Source: org_study_id
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