Massage, Oxidative and Antioxidant Enzymes in Hemodialysis Patients With Restless Legs Syndrome(RLS)

Restless Legs Syndrome Clinical Trial

— RLS  

Official title:

The Effect of Massage on Oxidative and Antioxidant Enzymes in Hemodialysis Patients With Restless Legs Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05787080
• Other study ID #: G Turgay
• Status: Completed
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: January 2024
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 legs syndrome.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 1, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Receiving hemodialysis treatment for at least 6 months, 3 days a week for 4 hours,

2. Patients with RLS according to the diagnostic criteria of the International RLS study group,

3. No psychiatric problems,

4. No neurological deficit,

5. Exercise and physical therapy modalities have not been applied in the last year,

6. 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:

1. Hemiplegic patients

2. Patients with heart failure

3. Individuals with chronic obstructive pulmonary diseases

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Psychomotor Agitation
• Renal Failure Chronic
• Renal Insufficiency
• Restless Legs Syndrome
• Syndrome

Intervention

Other:
• Massage
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.

Locations

Country	Name	City	State
Turkey	Baskent University	Ankara	Türkiye

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 week
Primary	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.	1 week
Secondary	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.	1 week
Secondary	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.	1 week