Hemodialysis Complication
Conditions
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
Interventions
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
OTHERcnotrol 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
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
Sponsors
MTI University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Patient Health Questionnaire (PHQ-9) | base line and 12 weeks | The (PHQ-9) is efficient, reliable, and highly acceptable for diagnosing depression and anxiety |
Countries
Egypt
Outcome results
None listed