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

NCT05787080 | Completed

• 1 other identifier: G Turgay
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Failure Chronic; Restless Legs Syndrome

Keywords

renal failure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Effect of vibration massage on blood level of Malondialdehyde

  1 week

• Effect of vibration massage on blood level of Erythrocyte Reducte Glutathione

  1 week

Study Arms (2)

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.

Other: Massage

Control Group

NO INTERVENTION

No intervention will be made on the patients in the control group.

Interventions

Massage OTHER

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.

Massage Group/experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. .

You may not qualify if:

• Hemiplegic patients
• Patients with heart failure
• Individuals with chronic obstructive pulmonary diseases

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University

Ankara, Türkiye, 109861, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Restless Legs Syndrome; Renal Insufficiency

Interventions

Massage

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: participant and outcomes assessor will not be in the control and experimental group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: Massage/experimental Group- control Group

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: March 28, 2023
• Study Start: September 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: January 1, 2024
• Last Updated: February 15, 2024

Record last verified: 2024-01

Locations

TU (1)