PMR Versus MLD on RLS and Sleep Quality in Hemodialysis Patients

Not Applicable

Completed

• Conditions: Hemodialysis Complication
• Interventions: Other: Manual lymphatic drainage (MLD); Other: cnotrol group; Other: Progressive muscle relaxation (PMR)

• Registration Number: NCT06481800
• Lead Sponsor: MTI University

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2024-04-15
• Study First Submitted: 2024-06-25
• Study First Submitted QC: 2024-06-28
• Status Verified: 2024-07
• Study First Posted: 2024-07-01
• Primary Completion: 2024-07-20
• Study Completion: 2024-07-21
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group (B): Manual lymphatic drainage (MLD)	Manual lymphatic drainage (MLD)	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.
Group (C):control	cnotrol group	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
Group (A):Progressive muscle relaxation (PMR)	Progressive muscle relaxation (PMR)	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

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index (PSQI)	base line and 12 weeks	It is a self-report questionnaire that assesses sleep quality. The patient asked to rate his/ her sleep quality
International restless legs syndrome rating scale (IRLS)	base line and 12 weeks.	It consists of 10 questions considering different aspects of the impact of RLS on a patient's life. Each question can be answered with a Likert-type scale ranging from "none" (0) to "very severe" (4).

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ-9)	base line and 12 weeks	The (PHQ-9) is efficient, reliable, and highly acceptable for diagnosing depression and anxiety
Leg cramps severity scale	base line and 12 weeks	0 no pain (no early symptoms), 1: mild (under cramps, with early symptoms), 2: discomforting (a cramp, recovery immediate, tolerable), 3: distressing (cramps once or twice, nurse call, recover with some treatment, cramps after HD), 4: horrible and excruciating (several cramps, nurse call, not tolerable, including a cessation of HD, cramps after HD).

Trial Locations

Locations (1)

Ahmed Mohamed Ahmed Abdelhady; 🇪🇬 Cairo, Egypt