NCT06806891

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2025

Completed
Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

January 29, 2025

Last Update Submit

January 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • international RLS Study Group Rating

    it will assess the severity of the problem (restless leg syndrome)

    it will be measured after 12 weeks

Secondary Outcomes (12)

  • Pittsburg sleep quality index

    it will be measured after 12 weeks

  • fatigue severity scale

    it will be measured after 12 weeks

  • sit to stand test

    it will be measured after 12 weeks

  • physical component of short form 12

    it will be measured after 12 weeks

  • mental component of short form 12

    it will be measured after 12 weeks

  • +7 more secondary outcomes

Study Arms (2)

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.

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 .

Interventions

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.

group number 1

Eligibility Criteria

Age35 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsself-representation of gender identity.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy Cairo university

Dokki, Giza Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

HemolysisRestless Legs Syndrome

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersParasomniasMental Disorders

Study Officials

  • Ali MA Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali MA Ismail, lecturer

CONTACT

alshymaa abdelazim, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

January 29, 2025

First Posted

February 4, 2025

Study Start

November 6, 2024

Primary Completion

March 6, 2025

Study Completion

March 6, 2025

Last Updated

February 4, 2025

Record last verified: 2025-01

Locations