HemolysisNCT06806891
Restless Leg Syndrome: Is There a Response to Buddhist Walking Meditation in Hemodialysis
A study testing Buddhist walking meditation in people with Hemolysis and Restless Legs Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
the restless leg syndrome is a common complaint in person who undergo hemodialysis. Buddhist walking meditation efficacy was not investigated in those population Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Hemolysis, Restless Legs Syndrome
- What is being tested?
- Buddhist walking meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Nov 2024to 6 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- hemodialysis patient (40)
- complain of restless leg syndrome
- non obese patients
Who cannot join
- cardiac patients
- chest diseases
- mental diseases
- hepatic diseases
- lower limb orthopedic hurting
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
faculty of physical therapy Cairo university
Dokki, Giza Governorate
Ali Ismail, lecturer, +201005154209, ali.mohamed@pt.cu.edu.eg
Ali MA Ismail, Lecturer
About this study
the restless leg syndrome is a common complaint in person who undergo hemodialysis. Buddhist walking meditation efficacy was not investigated in those population
Read the detailed description
the total participants will be 40. all patients will be on hemodialyis. they complain restless leg syndrome. the participants will be divided to group I which received Buddhist walking meditation. this program of meditation will be 30 minutes thrice weekly. before and after buddhist meditation walking, there will be 5 minutes stretching exercises working as warm up or cooling down respectively. the other group will serve as control one .. the number of patient in every group will be 20. the total duration of Buddhist walking meditation will be 12 weeks.
- Conditions
- Hemolysis, Restless Legs Syndrome
- Being tested
- Buddhist walking meditation
- Medical subject headings
- Hemolysis, Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buddhist walking meditationBehavioural
the participants will be on hemodialyis. they complain restless leg syndrome. the participants will receive Buddhist walking meditation. this program of meditation will be 30 minutes thrice weekly. before and after Buddhist walking meditation .. The number of patients in the group will be 20. the total duration of Buddhist walking meditation will be 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| group number 1 | Experimental | the participants will be on hemodialyis. they complain restless leg syndrome. the participants will receive Buddhist walking meditation. this program of meditation will be 30 minutes thrice weekly. before and after Buddhist walking meditation .. the number of patients in the group will be 20. the total duration of Buddhist walking meditation will be 12 weeks. Receives: Behavioral: Buddhist walking meditation |
| group number 2 | No intervention | the participants will be on hemodialyis. they complain restless leg syndrome. the number of patients in the group will be 20. this group will be control group that will not receive training . |
What is being measured
The primary outcome is the main question the study is designed to answer.
international RLS Study Group Rating
it will assess the severity of the problem (restless leg syndrome)
Measured: it will be measured after 12 weeks
Secondary outcomes (12)
Pittsburg sleep quality index
it will assess sleep quality
Measured: it will be measured after 12 weeks
fatigue severity scale
it will assess fatigue level
Measured: it will be measured after 12 weeks
sit to stand test
it will assess number of sit to stand in 30 seconds
Measured: it will be measured after 12 weeks
physical component of short form 12
a questionnaire will assess physical abilities of patients
Measured: it will be measured after 12 weeks
mental component of short form 12
a questionnaire will assess mental status of patients
Measured: it will be measured after 12 weeks
beck depression inventory
a questionnaire will assess depression status of patients
Measured: It will be measured after 12 weeks
Trait Anxiety Inventory
it will assess anxiety in patients
Measured: it will be measured after 12 weeks
diatolic blood pressure
it will be assessed manually
Measured: it will be measured after 12 weeks
systolic blood pressure
it will be assessed manually
Measured: it will be measured after 12 weeks
cortisol
it will be measured in serum
Measured: It will be measured after 12 weeks
C reactive protein
it will be measured in serum
Measured: It will be measured after 12 weeks
nitric oxide
it will be measured in serum
Measured: It will be measured after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start6 Nov 2024
- Primary completion6 Mar 2025 (estimated)
- Study completion6 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemolysisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali MA Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806891
- Sponsor's protocol ID
- P.T.REC/012/005557
- Status last verified
- Jan 2025
- First submitted
- 29 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restless Leg Syndrome: Is There a Response to Buddhist Walking Meditation in Hemodialysis
- ClinicalTrials.gov ID
- NCT06806891
- Acronym / sponsor ID
- P.T.REC/012/005557
- Conditions
- Hemolysis, Restless Legs Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 6 Mar 2025 (estimated)
- Study completion
- 6 Mar 2025 (estimated)
- First posted
- 4 Feb 2025 (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.
the restless leg syndrome is a common complaint in person who undergo hemodialysis. Buddhist walking meditation efficacy was not investigated in those population
Detailed description
the total participants will be 40. all patients will be on hemodialyis. they complain restless leg syndrome. the participants will be divided to group I which received Buddhist walking meditation. this program of meditation will be 30 minutes thrice weekly. before and after buddhist meditation walking, there will be 5 minutes stretching exercises working as warm up or cooling down respectively. the other group will serve as control one .. the number of patient in every group will be 20. the total duration of Buddhist walking meditation will be 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group number 1 | Experimental | Behavioral: Buddhist walking meditationthe participants will be on hemodialyis. they complain restless leg syndrome. the participants will receive Buddhist walking meditation. this program of meditation will be 30 minutes thrice weekly. before and after Buddhist walking meditation .. the number of patients in the group will be 20. the total duration of Buddhist walking meditation will be 12 weeks. |
| group number 2 | No intervention | –the participants will be on hemodialyis. they complain restless leg syndrome. the number of patients in the group will be 20. this group will be control group that will not receive training . |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- hemodialysis patient (40)
- complain of restless leg syndrome
- non obese patients
Key exclusion criteria (5 listed)
- cardiac patients
- chest diseases
- mental diseases
- hepatic diseases
- lower limb orthopedic hurting
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 |
|---|---|---|
| Buddhist walking meditationthe participants will be on hemodialyis. they complain restless leg syndrome. the participants will receive Buddhist walking meditation. this program of meditation will be 30 minutes thrice weekly. before and after Buddhist walking meditation .. The number of patients in the group will be 20. the total duration of Buddhist walking meditation will be 12 weeks. | Behavioural | group number 1 |
Primary outcome
international RLS Study Group Rating
Time frame: it will be measured after 12 weeks
it will assess the severity of the problem (restless leg syndrome)
12 secondary outcomes
Pittsburg sleep quality index
Time frame: it will be measured after 12 weeks
fatigue severity scale
Time frame: it will be measured after 12 weeks
sit to stand test
Time frame: it will be measured after 12 weeks
physical component of short form 12
Time frame: it will be measured after 12 weeks
mental component of short form 12
Time frame: it will be measured after 12 weeks
beck depression inventory
Time frame: It will be measured after 12 weeks
Trait Anxiety Inventory
Time frame: it will be measured after 12 weeks
diatolic blood pressure
Time frame: it will be measured after 12 weeks
systolic blood pressure
Time frame: it will be measured after 12 weeks
cortisol
Time frame: It will be measured after 12 weeks
C reactive protein
Time frame: It will be measured after 12 weeks
nitric oxide
Time frame: It will be measured after 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
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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.
Ali MA Ismail, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buddhist walking meditation in people with Hemolysis and Restless Legs Syndrome, run by Cairo 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 4 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali MA Ismail, lecturer (01005154209, ali.mohamed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
international RLS Study Group Rating (time frame: it will be measured after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2025.