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Completed

NCT Number: NCT06481800

PMR Versus MLD on RLS and Sleep Quality in Hemodialysis Patients

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

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Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahmed Mohamed Ahmed Abdelhady

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progressive muscle relaxation (PMR)

Other

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

cnotrol group

Other

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,Regular monitoring of kidney function, blood tests

Manual Lymphatic Drainage (MLD)

Other

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

Primary outcomes

  1. International restless legs syndrome rating scale (IRLS)

    Time frame: 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).

  2. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: base line and 12 weeks

    It is a self-report questionnaire that assesses sleep quality. The patient asked to rate his/ her sleep quality

Secondary outcomes

  1. Leg cramps severity scale

    Time frame: 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).

  2. Patient Health Questionnaire (PHQ-9)

    Time frame: base line and 12 weeks

    The (PHQ-9) is efficient, reliable, and highly acceptable for diagnosing depression and anxiety

Sponsors and collaborators

Lead sponsor

MTI University

Other

Registry information

Official study title

Progressive Muscle Relaxation Versus Manual Lymphatic Drainage on Restless Leg Syndrome and Sleep Quality in Hemodialysis Patients

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 1, 2024
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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