Restless Leg Syndrome: Is There a Response to Buddhist Walking Meditation in Hemodialysis

January 29, 2025 updated by: Ali Mohamed Ali ismail, Cairo University
the restless leg syndrome is a common complaint in person who undergo hemodialysis. Buddhist walking meditation efficacy was not investigated in those population

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Giza
      • Dokki, Giza, Egypt
        • Recruiting
        • Faculty of Physical Therapy Cairo University
        • Contact:
        • Principal Investigator:
          • Ali MA Ismail, Lecturer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • hemodialysis patient (40)
  • complain of restless leg syndrome
  • non obese patients

Exclusion Criteria:

  • cardiac patients
  • chest diseases
  • mental diseases
  • hepatic diseases
  • lower limb orthopedic hurting

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group number 1
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.
Behavioral: Buddhist walking meditation
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.
No Intervention: group number 2
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
it will be measured after 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburg sleep quality index
Time Frame: it will be measured after 12 weeks
it will assess sleep quality
it will be measured after 12 weeks
fatigue severity scale
Time Frame: it will be measured after 12 weeks
it will assess fatigue level
it will be measured after 12 weeks
sit to stand test
Time Frame: it will be measured after 12 weeks
it will assess number of sit to stand in 30 seconds
it will be measured after 12 weeks
physical component of short form 12
Time Frame: it will be measured after 12 weeks
a questionnaire will assess physical abilities of patients
it will be measured after 12 weeks
mental component of short form 12
Time Frame: it will be measured after 12 weeks
a questionnaire will assess mental status of patients
it will be measured after 12 weeks
beck depression inventory
Time Frame: It will be measured after 12 weeks
a questionnaire will assess depression status of patients
It will be measured after 12 weeks
Trait Anxiety Inventory
Time Frame: it will be measured after 12 weeks
it will assess anxiety in patients
it will be measured after 12 weeks
diatolic blood pressure
Time Frame: it will be measured after 12 weeks
it will be assessed manually
it will be measured after 12 weeks
systolic blood pressure
Time Frame: it will be measured after 12 weeks
it will be assessed manually
it will be measured after 12 weeks
cortisol
Time Frame: It will be measured after 12 weeks
it will be measured in serum
It will be measured after 12 weeks
C reactive protein
Time Frame: It will be measured after 12 weeks
it will be measured in serum
It will be measured after 12 weeks
nitric oxide
Time Frame: It will be measured after 12 weeks
it will be measured in serum
It will be measured after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Ali MA Ismail, lecturer, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2024

Primary Completion (Estimated)

March 6, 2025

Study Completion (Estimated)

March 6, 2025

Study Registration Dates

First Submitted

January 29, 2025

First Submitted That Met QC Criteria

January 29, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 29, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/005557

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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