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PMR Versus MLD on RLS and Sleep Quality in Hemodialysis Patients

M

MTI University

Status

Completed

Conditions

Hemodialysis Complication

Treatments

Other: Manual lymphatic drainage (MLD)
Other: Progressive muscle relaxation (PMR)
Other: cnotrol group

Study type

Interventional

Funder types

Other

Identifiers

NCT06481800
P.T.REC/012/005202

Details and patient eligibility

About

Progressive muscle relaxation versus manual lymphatic drainage on restless leg syndrome and sleep quality in hemodialysis patients

Full description

Restless legs syndrome (RLS) is a sensory motor disturbance with features of both neurologic and sleeps disorders. The patients complain of strong, irresistible urge to move the legs, often accompanied by uncomfortable sensations deeply in the legs. Poor sleep quality affects many hemodialysis patients and can potentially predict their morbidity, mortality, quality of life and pattern of medication use. Progressive muscle relaxation (PMR) is one way to improve physical work capacity and reduce functional limitations. Manual lymphatic drainage (MLD) is a traditional therapy in which the hands work on the tissues of the body, including tuina, acupressure, and the likes. It is beneficial to the well-being of patients both physically and mentally

Enrollment

120 patients

Sex

All

Ages

35 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male and female adults ranging from 35- 65 years old.
  • Able to communicate verbally and agree to participate in the study.
  • On maintenance arteriovenous fistula (AVF) hemodialysis 3 times weekly.
  • None of the research participants had a lower extremity dialysis graft, and they were all taking medication to maintain their health.
  • Prior to the study procedure, all patients underwent a nephrologist assessment
  • All patients had good compliance with their dialysis treatment (not missing more than 2 dialysis sessions in the prior 3 months

Exclusion criteria

  • Peripheral neuropathy or vascular diseases of the lower limbs.
  • Skin diseases including acute psoriasis or eczema.
  • Recent fractures or lower limbs surgeries.
  • Feet injuries including severe muscle weakness, bruises, ulcers, Open wounds or recent burns

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 3 patient groups

Group (A):Progressive muscle relaxation (PMR)
Experimental group
Description:
patients receive progressive muscle relaxation (PMR) for 20 minutes after each dialysis session during the first 2 hours the dialysis treatment with routine medical care for dialysis patients
Treatment:
Other: Progressive muscle relaxation (PMR)
Group (B): Manual lymphatic drainage (MLD)
Experimental group
Description:
patients receive Manual lymphatic drainage (MLD) for 20 minutes within after each dialysis session during the first 2 hours the dialysis treatment with routine medical care for dialysis patients.
Treatment:
Other: Manual lymphatic drainage (MLD)
Group (C):control
Active Comparator group
Description:
patients receive routine medical care for dialysis patients. Routine medical care for RLS and sleep quality in hemodialysis Anemia management, electrolyte balance,Avoiding caffeine and alcohol, establishing a regular sleep schedule leg care,Medicines that increase dopamine in the brain, affecting calcium channels, Opioids , Gabapentin and Pregabali , Benzodiazepines
Treatment:
Other: cnotrol group

Trial contacts and locations

1

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Central trial contact

Ahmed m El fahl, ph.d; Heba m El feky, ph.d

Data sourced from clinicaltrials.gov

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