PMR Versus MLD on RLS and Sleep Quality in Hemodialysis Patients

NCT06481800 | Completed

• 1 other identifier: P.T.REC/012/005202
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemodialysis Complication

Outcome Measures

Primary Outcomes (2)

• International restless legs syndrome rating scale (IRLS)

  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).

  base line and 12 weeks.

• Pittsburgh Sleep Quality Index (PSQI)

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

  base line and 12 weeks

Secondary Outcomes (2)

• Leg cramps severity scale

  base line and 12 weeks

• Patient Health Questionnaire (PHQ-9)

  base line and 12 weeks

Study Arms (3)

Group (A):Progressive muscle relaxation (PMR)

EXPERIMENTAL

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

Other: Progressive muscle relaxation (PMR)

Group (B): Manual lymphatic drainage (MLD)

EXPERIMENTAL

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.

Other: Manual lymphatic drainage (MLD)

Group (C):control

ACTIVE COMPARATOR

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

Other: cnotrol group

Interventions

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

Group (A):Progressive muscle relaxation (PMR)

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

Group (C):control

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

Group (B): Manual lymphatic drainage (MLD)

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MTI University: lead

Study Sites (1)

Ahmed Mohamed Ahmed Abdelhady

Cairo, Egypt

Location

Related Links

• The effect of progressive muscle relaxation training on anxiety levels and quality of life in dialysis patients
• The Effect of Progressive Relaxation Exercises on Pain, Fatigue, and Quality of Life in Dialysis Patients

MeSH Terms

Interventions

Autogenic Training; Manual Lymphatic Drainage

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Drainage; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lectrurer of physical therapy for general surgery and dermatology

Model Details: 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

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: April 15, 2024
• Primary Completion: July 20, 2024
• Study Completion: July 21, 2024
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)