Hemodialysis ComplicationPhase 4NCT06452563
Amino Acids Supplementation and Exercise Intervention in Hemodialysis Patients
A Phase 4 study testing ketoanalogue supplementation and intradialytic exercise in people with Hemodialysis Complication and Malnutrition, run by Mansoura University at 1 site in Egypt.
Trial 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 ?… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hemodialysis Complication, Malnutrition
- What is being tested?
- ketoanalogue supplementation and intradialytic exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 12 May 2024to 30 Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Hemodialysis patients due to chronic kidney diseases
- Age between 18 - 60
Who cannot join
- Frail patients
- The patients who refused to participate
- Growth retarded patients
- Disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Amino Acids Supplementation and Exercise Intervention in Hemodialysis Patients: Effects on Muscle and Fatigue - a Randomized Controlled Trial
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.
Read more
Researchers will compare the effects of these interventions on the muscle mass and fatigue, among four groups:
- A group that will be only taking AAs supplementation
- A group taking AAs supplementation along with intradialytic exercise
- A group only performing intradialytic exercise
- 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
- Being tested
- ketoanalogue supplementation, intradialytic exercise
- Keywords
- haemodialysis patients, ketoanalogs, malnutrition, exercise, Muscle function
- Medical subject headings
- Malnutrition, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketoanalogue supplementationDietary 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
intradialytic exerciseOther
low-intensity exercise training composed of knee extension and hip abduction and flexion from a three-repetition maximum (3RM) using ankle weights
| Study group | Role | What they receive |
|---|---|---|
| Ketoanalogs Supplementation Group | Active comparator | Participants will receive daily a total of six tablets of Ketoanalogs Supplementation divided into three doses for three months . Receives: 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 . Receives: Dietary Supplement: ketoanalogue supplementation; Other: intradialytic exercise |
| Intradialytic exercise group | Active comparator | Participants will be asked to do intradialytic exercise only Receives: Other: intradialytic exercise |
| Control group | No intervention | Participants will not receive drug or do exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
skeletal muscle mass (SMM) will be assessed using the Inbody test before and after this trial .
Measured: 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 .
Measured: 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 .
Measured: 3 months
Secondary outcomes (1)
Fatigue score
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start12 May 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Magdy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452563
- Sponsor's protocol ID
- R.24.04.2576
- Status last verified
- Sep 2024
- First submitted
- 4 Jun 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amino Acids Supplementation and Exercise Intervention in Hemodialysis Patients: Effects on Muscle and Fatigue - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06452563
- Acronym / sponsor ID
- R.24.04.2576
- Conditions
- Hemodialysis Complication, Malnutrition
- Keywords
- haemodialysis patients, ketoanalogs, malnutrition, exercise, Muscle function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 May 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- A group that will be only taking AAs supplementation
- A group taking AAs supplementation along with intradialytic exercise
- A group only performing intradialytic exercise
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ketoanalogs Supplementation Group | Active comparator | Dietary Supplement: ketoanalogue supplementationParticipants will receive daily a total of six tablets of Ketoanalogs Supplementation divided into three doses for three months . |
| Ketoanalogs Supplementation and intradialytic exercise group | Active comparator | Dietary Supplement: ketoanalogue supplementation, Other: intradialytic exerciseParticipants will receive daily a total of six tablets of Ketoanalogs Supplementation divided into three doses for three months in addition to doing intradialytic exercise . |
| Intradialytic exercise group | Active comparator | Other: intradialytic exerciseParticipants will be asked to do intradialytic exercise only |
| Control group | No intervention | –Participants will not receive drug or do exercises |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Hemodialysis patients due to chronic kidney diseases
- Age between 18 - 60
Key exclusion criteria (4 listed)
- Frail patients
- The patients who refused to participate
- Growth retarded patients
- Disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ketoanalogue supplementationThis 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 | Dietary supplement | Ketoanalogs Supplementation Group, Ketoanalogs Supplementation and intradialytic exercise group |
| intradialytic exerciselow-intensity exercise training composed of knee extension and hip abduction and flexion from a three-repetition maximum (3RM) using ankle weights | Other | Intradialytic exercise group, Ketoanalogs Supplementation and intradialytic exercise group |
Primary outcome
Muscle mass
Time frame: 3 months
skeletal muscle mass (SMM) will be assessed using the Inbody test before and after this trial .
Muscle function test
Time frame: 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
Time frame: 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 .
1 secondary outcome
Fatigue score
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ketoanalogue supplementation and intradialytic exercise in people with Hemodialysis Complication and Malnutrition, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle mass (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.