NCT07575607

Brief Summary

The goal of this clinical trial is to compare the effects of reflexology and progressive muscle relaxation in reducing fatigue among hemodialysis patients and to determine which intervention provides greater relief from fatigue. The main question it aims to answer is: Is there any difference in effectiveness of reflexology and progressive muscle relaxation techniques in reducing fatigue levels among patients undergoing hemodialysis? Participents will be randomly assigned to one of three groups: Group 1: 20 participants will receive reflexology therapy 3 times per week for 12 weeks. Group 2: 20 participants will receive progressive muscle relaxation 3 times per week for 12 weeks. Group 3: 20 participants will be a controlled group. fatigue and sleep quality will be measured before and after the intervention using: Fatigue Severity Scale Pittsburgh Sleep Quality Index Epworth Sleepiness scale This study aims to offer safe, low cost and non-pharmacological method that can help hemodialysis patients in reducing fatigue and sleeping better.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

May 4, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
24 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 4, 2026

Last Update Submit

May 4, 2026

Conditions

Keywords

ReflexologyRelaxationFatigueprogressive Muscle RelaxationSleep QualityRenal Dialysisstage 5Non pharmacological interventionsChronic Kidney Disease (CKD)Renal Failure (RF)End Stage Renal Failure (ESRF)fatigue severity scale (FSS)Epworth sleepiness scale (ESS)Pittsburgh Sleep Quality (PSQI)Hemodialysis (HD)

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Fatigue severity scale (FSS) at 12 weeks

    Baseline and after 12 weeks of intervention

Secondary Outcomes (2)

  • Change from baseline in pittsburgh sleep Quality Index (PSQI) at 12 weeks

    Baseline and after 12 weeks of intervention

  • Change from baseline in Epworth Sleepiness Scale (ESS) at 12 weeks

    Baseline and after 12 weeks of intervention

Study Arms (3)

Reflexology

EXPERIMENTAL
Behavioral: reflexology

progressive muscle relaxation

EXPERIMENTAL
Behavioral: progressive muscle relaxation

control

OTHER
Other: Control

Interventions

reflexologyBEHAVIORAL

This group will receive reflexology on feet; each session lasts 20 minutes, the participants will receive reflexology therapy 3 times per week for 12 weeks. in addition, they will continue taking their prescribed medications and follow standard nutritional guidelines recommended for patients with chronic kidney disease.

Reflexology

This group will perform progressive muscle relaxation for 10 minutes per session,3 times per week for 12 weeks. in addition, they will continue taking their prescribed medications and follow standard nutritional guidelines recommended for patients with chronic kidney disease.

progressive muscle relaxation
ControlOTHER

the participants will be observed for 12 weeks. while continuing taking their prescribed medications and follow the standard nutritional guidelines recommended for patients with chronic kidney disease.

control

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients of both genders aged from 50 to 70 years old.
  • Patients are experiencing moderate to severe fatigue (as measured by a standardized fatigue scale).
  • Medically stable as determined by the attending nephrologist.
  • Able to understand and follow instructions for relaxation techniques

You may not qualify if:

  • History Patients with severe cognitive impairment or psychiatric disorders that interfere with participation.
  • Patients with foot ulcers, wounds, or any contraindications for foot reflexology.
  • Currently practicing any relaxation or complementary therapies regularly.
  • Patients with unstable medical conditions or undergoing treatment changes during the study period.
  • History of recent sugery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

El hussaynia Centeral Hospital - Nephrology Unit

Zagazig, Sharqia Governorate, 44654, Egypt

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicFatigueSleep Initiation and Maintenance DisordersRenal Insufficiency

Interventions

Musculoskeletal ManipulationsAutogenic Training

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationHypnosisMind-Body TherapiesPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Hania Muhammad selim

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
M.Sc candidate in faculty of physical, Cairo University

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 8, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

May 8, 2026

Record last verified: 2026-05

Locations