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

B

Baskent University

Status

Completed

Conditions

Restless Legs Syndrome
Renal Failure Chronic

Treatments

Other: Massage

Study type

Interventional

Funder types

Other

Identifiers

NCT05787080
G Turgay

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

42 participants in 2 patient groups

Massage Group/experimental
Experimental group
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.
Treatment:
Other: Massage
Control Group
No Intervention group
Description:
No intervention will be made on the patients in the control group.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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