PMR Versus MLD on RLS and Sleep Quality in Hemodialysis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-15

Study Completion Date

2024-07-21

Brief Summary

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

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Detailed Description

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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

Conditions

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Hemodialysis Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial. To assign patients to different treatment groups, a table of random numbers generated by a computer will be used. Patients will be allocated randomly into three groups using this method

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group (A):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

Group Type EXPERIMENTAL

Progressive muscle relaxation (PMR)

Intervention Type 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

Group (B): 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 Type EXPERIMENTAL

Manual lymphatic drainage (MLD)

Intervention Type 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

Group (C):control

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 Type ACTIVE_COMPARATOR

cnotrol group

Intervention Type 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

Interventions

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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

Intervention Type OTHER

cnotrol group

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

Intervention Type OTHER

Manual lymphatic drainage (MLD)

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No