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NCT Number: NCT06806891

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

the restless leg syndrome is a common complaint in person who undergo hemodialysis. Buddhist walking meditation efficacy was not investigated in those population

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Key information

Conditions

Hemolysis Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Pathologic Processes Pathological Conditions, Signs and Symptoms Restless Legs Syndrome Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of physical therapy Cairo university

Dokki, Giza Governorate, Egypt

Location status: Recruiting

Location contact

Ali Ismail, lecturer

CONTACT

[email protected]

+201005154209

Ali MA Ismail, Lecturer

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Buddhist walking meditation

Behavioral

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Pittsburg sleep quality index

    Time frame: it will be measured after 12 weeks

    it will assess sleep quality

  2. fatigue severity scale

    Time frame: it will be measured after 12 weeks

    it will assess fatigue level

  3. sit to stand test

    Time frame: it will be measured after 12 weeks

    it will assess number of sit to stand in 30 seconds

  4. physical component of short form 12

    Time frame: it will be measured after 12 weeks

    a questionnaire will assess physical abilities of patients

  5. mental component of short form 12

    Time frame: it will be measured after 12 weeks

    a questionnaire will assess mental status of patients

  6. beck depression inventory

    Time frame: It will be measured after 12 weeks

    a questionnaire will assess depression status of patients

  7. Trait Anxiety Inventory

    Time frame: it will be measured after 12 weeks

    it will assess anxiety in patients

  8. diatolic blood pressure

    Time frame: it will be measured after 12 weeks

    it will be assessed manually

  9. systolic blood pressure

    Time frame: it will be measured after 12 weeks

    it will be assessed manually

  10. cortisol

    Time frame: It will be measured after 12 weeks

    it will be measured in serum

  11. C reactive protein

    Time frame: It will be measured after 12 weeks

    it will be measured in serum

  12. nitric oxide

    Time frame: It will be measured after 12 weeks

    it will be measured in serum

Study contacts

Contact information is provided by the study sponsor or research team.

Ali MA Ismail, lecturer

CONTACT

[email protected]

01005154209

alshymaa abdelazim, lecturer

CONTACT

[email protected]

01033771553

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 4, 2025
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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