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

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.

Study Overview

• Status: Completed
• Conditions: Restless Legs Syndrome; Renal Failure Chronic
• Intervention / Treatment: Other: Massage

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Türkiye
    • Ankara, Türkiye, Turkey, 109861
      • Başkent University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Massage Group/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.	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.
No Intervention: Control Group; No intervention will be made on the patients in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Baskent University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: renal failure
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Kidney Diseases; Urologic Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease Attributes; Disease; Dyskinesias; Psychomotor Disorders; Parasomnias; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Syndrome; Psychomotor Agitation; Restless Legs Syndrome; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: G Turgay

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No