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

Sponsor
Baskent University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05787080
Collaborator
(none)
45
1
2
3.9
11.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Massage
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Massage/experimental Group- control GroupMassage/experimental Group- control Group
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
participant and outcomes assessor will not be in the control and experimental group.
Primary Purpose:
Supportive Care
Official Title:
The Effect of Massage on Oxidative and Antioxidant Enzymes in Hemodialysis Patients With Restless Legs Syndrome
Actual Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
May 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Malondialdehyde (MDA) levels of RLS patients [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).

  2. Erythrocyte Reducte Glutathione (GSH) levels of RLS patients [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.

Secondary Outcome Measures

  1. Effect of vibration massage on blood level of Malondialdehyde [1 week]

    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.

  2. Effect of vibration massage on blood level of Erythrocyte Reducte Glutathione [1 week]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baskent University Ankara Türkiye Turkey 109861

Sponsors and Collaborators

  • Baskent University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gülay Turgay, assistant professor, Baskent University
ClinicalTrials.gov Identifier:
NCT05787080
Other Study ID Numbers:
  • G Turgay
First Posted:
Mar 28, 2023
Last Update Posted:
Mar 28, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gülay Turgay, assistant professor, Baskent University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 28, 2023