Hemodialysis ComplicationNCT06481800
PMR Versus MLD on RLS and Sleep Quality in Hemodialysis Patients
A study testing Progressive muscle relaxation (PMR), cnotrol group and Manual lymphatic drainage (MLD) in people with Hemodialysis Complication, run by MTI University at 1 site in Egypt.
Trial summary
Progressive muscle relaxation versus manual lymphatic drainage on restless leg syndrome and sleep quality in hemodialysis patients Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Hemodialysis Complication
- What is being tested?
- Progressive muscle relaxation (PMR), cnotrol group and Manual lymphatic drainage (MLD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2024to 21 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Progressive Muscle Relaxation Versus Manual Lymphatic Drainage on Restless Leg Syndrome and Sleep Quality in Hemodialysis Patients
Progressive muscle relaxation versus manual lymphatic drainage on restless leg syndrome and sleep quality in hemodialysis patients
Read the 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
- Conditions
- Hemodialysis Complication
- Being tested
- Progressive muscle relaxation (PMR), cnotrol group, Manual lymphatic drainage (MLD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 groupOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: Other: cnotrol group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: base line and 12 weeks
Secondary outcomes (2)
Leg cramps severity scale
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).
Measured: base line and 12 weeks
Patient Health Questionnaire (PHQ-9)
The (PHQ-9) is efficient, reliable, and highly acceptable for diagnosing depression and anxiety
Measured: base line and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start15 Apr 2024
- Primary completion20 Jul 2024
- Study completion21 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481800
- Sponsor's protocol ID
- P.T.REC/012/005202
- Status last verified
- Jul 2024
- First submitted
- 25 Jun 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elfahl AM, Elfeky HM. Progressive muscle relaxation versus manual lymphatic drainage on restless leg syndrome and sleep quality in hemodialysis patients: Randomized Controlled Trial. J Bodyw Mov Ther. 2025 Oct;44:549-557. doi: 10.1016/j.jbmt.2025.06.015. Epub 2025 Jun 18.
PubMed 40954628
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressive Muscle Relaxation Versus Manual Lymphatic Drainage on Restless Leg Syndrome and Sleep Quality in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT06481800
- Acronym / sponsor ID
- P.T.REC/012/005202
- Conditions
- Hemodialysis Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 20 Jul 2024 (actual)
- Study completion
- 21 Jul 2024 (actual)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Group (A):Progressive muscle relaxation (PMR) | Experimental | Other: 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 (B): Manual lymphatic drainage (MLD) | Experimental | Other: 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 | Active comparator | Other: cnotrol grouppatients 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 |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Group (A):Progressive muscle relaxation (PMR) |
| cnotrol groupRoutine 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 | Other | Group (C):control |
| 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 | Other | Group (B): Manual lymphatic drainage (MLD) |
Primary outcome
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).
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
2 secondary outcomes
Leg cramps severity scale
Time frame: base line and 12 weeks
Patient Health Questionnaire (PHQ-9)
Time frame: base line and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Derived from this study: PubMed 40954628Elfahl AM, Elfeky HM. Progressive muscle relaxation versus manual lymphatic drainage on restless leg syndrome and sleep quality in hemodialysis patients: Randomized Controlled Trial. J Bodyw Mov Ther. 2025 Oct;44:549-557. doi: 10.1016/j.jbmt.2025.06.015. Epub 2025 Jun 18.
- The effect of progressive muscle relaxation training on anxiety levels and quality of life in dialysis patientsLink provided by the sponsor.
- The Effect of Progressive Relaxation Exercises on Pain, Fatigue, and Quality of Life in Dialysis PatientsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive muscle relaxation (PMR), cnotrol group and Manual lymphatic drainage (MLD) in people with Hemodialysis Complication, run by MTI University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International restless legs syndrome rating scale (IRLS) (time frame: base line and 12 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06481800, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.