Back to resultsMassage, Oxidative and Antioxidant Enzymes in Hemodialysis Patients With Restless Legs Syndrome(RLS) (RLS)
Primary Purpose
Renal Failure Chronic, Restless Legs Syndrome
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Massage
Sponsored by
About this trial
This is an interventional supportive care trial for Renal Failure Chronic focused on measuring renal failure
Eligibility Criteria
Inclusion Criteria: 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. . Exclusion Criteria: Hemiplegic patients Patients with heart failure Individuals with chronic obstructive pulmonary diseases
Sites / Locations
- Baskent University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Massage Group/experimental
Control Group
Arm Description
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.
No intervention will be made on the patients in the control group.
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05787080
Brief Title
Massage, Oxidative and Antioxidant Enzymes in Hemodialysis Patients With Restless Legs Syndrome(RLS)
Acronym
RLS
Official Title
The Effect of Massage on Oxidative and Antioxidant Enzymes in Hemodialysis Patients With Restless Legs Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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 did 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure Chronic, Restless Legs Syndrome
Keywords
renal failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Massage/experimental Group- control Group
Masking
ParticipantOutcomes Assessor
Masking Description
participant and outcomes assessor will not be in the control and experimental group.
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Massage Group/experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention will be made on the patients in the control group.
Intervention Type
Other
Intervention Name(s)
Massage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Malondialdehyde (MDA) levels of RLS patients
Description
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).
Time Frame
1 week
Title
Erythrocyte Reducte Glutathione (GSH) levels of RLS patients
Description
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.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Effect of vibration massage on blood level of Malondialdehyde
Description
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.
Time Frame
1 week
Title
Effect of vibration massage on blood level of Erythrocyte Reducte Glutathione
Description
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.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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. .
Exclusion Criteria:
Hemiplegic patients
Patients with heart failure
Individuals with chronic obstructive pulmonary diseases
Facility Information:
Facility Name
Baskent University
City
Ankara
State/Province
Türkiye
ZIP/Postal Code
109861
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Massage, Oxidative and Antioxidant Enzymes in Hemodialysis Patients With Restless Legs Syndrome(RLS)
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