Renal Failure ChronicRLSNCT05787080
Massage, Oxidative and Antioxidant Enzymes in Hemodialysis Patients With Restless Legs Syndrome(RLS)
A study testing Massage in people with Renal Failure Chronic and Restless Legs Syndrome, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
This study; It will be done to evaluate the presence of oxidative stress and its effects on lipid peroxidation products and antioxidant parameters after massage application and the possible effects of the appropriate massage protocol applied to the patients on oxidative stress in hemodialysis patients with restless… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Failure Chronic, Restless Legs Syndrome
- What is being tested?
- Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Jan 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Receiving hemodialysis treatment for at least 6 months, 3 days a week for 4 hours,
- Patients with RLS according to the diagnostic criteria of the International RLS study group,
- No psychiatric problems,
- No neurological deficit,
- Exercise and physical therapy modalities have not been applied in the last year,
- In the laboratory examinations, the kinetic indicators of dialysis adequacy are within the desired target range (Kt/V: 1.2-1.3; URR: 60-65%), and there are no pathological findings (fracture, dislocation, tumor, infection) in the radiological examinations. .
Who cannot join
- Hemiplegic patients
- Patients with heart failure
- Individuals with chronic obstructive pulmonary diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Massage on Oxidative and Antioxidant Enzymes in Hemodialysis Patients With Restless Legs Syndrome
This study; It will be done to evaluate the presence of oxidative stress and its effects on lipid peroxidation products and antioxidant parameters after massage application and the possible effects of the appropriate massage protocol applied to the patients on oxidative stress in hemodialysis patients with restless legs syndrome.
Read the detailed description
In this study, the following research hypotheses will be tested. H0a: Individuals with restless legs syndrome receiving hemodialysis treatment; In the second hour of hemodialysis, massage applied to both calf muscles for 10 minutes three times a week for one month is not affect the oxidative and antioxidant enzymes of the patients.
H1a: Individuals with restless legs syndrome receiving hemodialysis treatment; In the second hour of hemodialysis, massage applied to both calf muscles for 10 minutes three times a week for one month is effective on the oxidative and antioxidant enzymes of the patients.
- Conditions
- Renal Failure Chronic, Restless Legs Syndrome
- Being tested
- Massage
- Keywords
- renal failure
- Medical subject headings
- Renal Insufficiency, Chronic, Restless Legs Syndrome, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageOther
In the second hour of hemodialysis, vibration is applied to both calf muscles of the patients for 10 minutes three times a week for four weeks at low voltages.
| Study group | Role | What they receive |
|---|---|---|
| Massage Group/experimental | Experimental | Blood tests will be taken at the entrance of dialysis from all participants. Then, in the second hour of hemodialysis, low voltage vibrations will be applied to both calf muscles of the patients for 10 minutes, three times a week for one month.Vibration application will be made with this device 53 Hz head. The vibration application will be performed for 2.5 minutes, starting from the medial side of the gastrocnemius (calf) muscle in both legs and moving it longitudinally from distal to proximal and from back to distal in a straight line within 20 seconds. Then this treatment will be applied to the lateral side of the gastrocnemius muscle for 2.5 minutes. This cycle will be repeated twice. After the one-month application period is completed, blood tests will be taken from all participants at the entrance to hemodialysis. Receives: Other: Massage |
| Control Group | No intervention | No intervention will be made on the patients in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malondialdehyde (MDA) levels of RLS patients
In patients diagnosed with RLS, their blood will be taken on the same day and their plasma will be collected by centrifugation. In RLS patients, cells are expected to undergo lipid peroxidation depending on the disease. This causes cell and tissue damage due to oxidative stress. Damage can also increase the severity and extent of the pain. For this reason, the degree of degradation will be determined by measuring the color reaction-based concentration (nmol/ml plasma) formed as a result of the reaction of malondialdehyde, the degradation product of lipids, which is an indicator of lipid peroxidation, with thiobarbituric acid (TBA).
Measured: 1 week
Erythrocyte Reducte Glutathione (GSH) levels of RLS patients
Reduced glutathione is needed to stay healthy and prevent disease and protect from the effects of aging, immune function and control of inflammation. After adding an equal amount of 10% TCA to plasma samples from 24 RLS patients. It was centrifuged at 4000 rpm at +4ºC for 10 minutes. 0.5 ml of the upper phase is taken and 2 ml of 0.3 M Na2HPO4, 2H2O and 0.2 ml of dithiobisnitro benzoic acid are added on it, and then 412 nm. will be read in the spectrophotometer and their concentrations will be given in terms of micromole (µmol) / ml plasma. This will also confirm the concentration of lipid peroxidation present.
Measured: 1 week
Secondary outcomes (2)
Effect of vibration massage on blood level of Malondialdehyde
It is expected that a decrease in the concentration of MDA and an increase in the rate of reduced glutathione (GSH) are expected, since it is thought that the vibration vibration massage applied to the same patients may cause the intercellular fluid and blood mobilization due to heat and vibration on the muscle tissue, thereby lowering the pain threshold.
Measured: 1 week
Effect of vibration massage on blood level of Erythrocyte Reducte Glutathione
It is expected that a decrease in the concentration of MDA and an increase in the rate of reduced glutathione (GSH) are expected, since it is thought that the vibration vibration massage applied to the same patients may cause the intercellular fluid and blood mobilization due to heat and vibration on the muscle tissue, thereby lowering the pain threshold.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start1 Sep 2023
- Primary completion30 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Failure ChronicStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Massage/experimental Group- control Group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülay Turgay, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787080
- Sponsor's protocol ID
- G Turgay
- Acronym
- RLS
- Status last verified
- Jan 2024
- First submitted
- 6 Feb 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Massage on Oxidative and Antioxidant Enzymes in Hemodialysis Patients With Restless Legs Syndrome
- ClinicalTrials.gov ID
- NCT05787080
- Acronym / sponsor ID
- RLS / G Turgay
- Conditions
- Renal Failure Chronic, Restless Legs Syndrome
- Keywords
- renal failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 28 Mar 2023 (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.
This study; It will be done to evaluate the presence of oxidative stress and its effects on lipid peroxidation products and antioxidant parameters after massage application and the possible effects of the appropriate massage protocol applied to the patients on oxidative stress in hemodialysis patients with restless legs syndrome.
Detailed description
In this study, the following research hypotheses will be tested. H0a: Individuals with restless legs syndrome receiving hemodialysis treatment; In the second hour of hemodialysis, massage applied to both calf muscles for 10 minutes three times a week for one month is not affect the oxidative and antioxidant enzymes of the patients.
H1a: Individuals with restless legs syndrome receiving hemodialysis treatment; In the second hour of hemodialysis, massage applied to both calf muscles for 10 minutes three times a week for one month is effective on the oxidative and antioxidant enzymes of the patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Massage/experimental Group- control Group
| Arm | Type | Receives |
|---|---|---|
| Massage Group/experimental | Experimental | Other: MassageBlood tests will be taken at the entrance of dialysis from all participants. Then, in the second hour of hemodialysis, low voltage vibrations will be applied to both calf muscles of the patients for 10 minutes, three times a week for one month.Vibration application will be made with this device 53 Hz head. The vibration application will be performed for 2.5 minutes, starting from the medial side of the gastrocnemius (calf) muscle in both legs and moving it longitudinally from distal to proximal and from back to distal in a straight line within 20 seconds. Then this treatment will be applied to the lateral side of the gastrocnemius muscle for 2.5 minutes. This cycle will be repeated twice. After the one-month application period is completed, blood tests will be taken from all participants at the entrance to hemodialysis. |
| Control Group | No intervention | –No intervention will be made on the patients in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Receiving hemodialysis treatment for at least 6 months, 3 days a week for 4 hours,
- Patients with RLS according to the diagnostic criteria of the International RLS study group,
- No psychiatric problems,
- No neurological deficit,
- Exercise and physical therapy modalities have not been applied in the last year,
Key exclusion criteria (3 listed)
- Hemiplegic patients
- Patients with heart failure
- Individuals with chronic obstructive pulmonary diseases
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 |
|---|---|---|
| MassageIn the second hour of hemodialysis, vibration is applied to both calf muscles of the patients for 10 minutes three times a week for four weeks at low voltages. | Other | Massage Group/experimental |
Primary outcome
Malondialdehyde (MDA) levels of RLS patients
Time frame: 1 week
In patients diagnosed with RLS, their blood will be taken on the same day and their plasma will be collected by centrifugation. In RLS patients, cells are expected to undergo lipid peroxidation depending on the disease. This causes cell and tissue damage due to oxidative stress. Damage can also increase the severity and extent of the pain. For this reason, the degree of degradation will be determined by measuring the color reaction-based concentration (nmol/ml plasma) formed as a result of the reaction of malondialdehyde, the degradation product of lipids, which is an indicator of lipid peroxidation, with thiobarbituric acid (TBA).
Erythrocyte Reducte Glutathione (GSH) levels of RLS patients
Time frame: 1 week
Reduced glutathione is needed to stay healthy and prevent disease and protect from the effects of aging, immune function and control of inflammation. After adding an equal amount of 10% TCA to plasma samples from 24 RLS patients. It was centrifuged at 4000 rpm at +4ºC for 10 minutes. 0.5 ml of the upper phase is taken and 2 ml of 0.3 M Na2HPO4, 2H2O and 0.2 ml of dithiobisnitro benzoic acid are added on it, and then 412 nm. will be read in the spectrophotometer and their concentrations will be given in terms of micromole (µmol) / ml plasma. This will also confirm the concentration of lipid peroxidation present.
2 secondary outcomes
Effect of vibration massage on blood level of Malondialdehyde
Time frame: 1 week
Effect of vibration massage on blood level of Erythrocyte Reducte Glutathione
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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 study testing Massage in people with Renal Failure Chronic and Restless Legs Syndrome, run by Baskent University at 1 site in Turkey (Türkiye).
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 15 Feb 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 Turkey (Türkiye). 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Malondialdehyde (MDA) levels of RLS patients (time frame: 1 week). The study lists 2 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 15 Feb 2024.