Reflexology Versus Progressive Muscle Relaxation for Fatigue in Hemodialysis Patients (PMR-HD)

May 8, 2026 updated by: Farah Mohammed Mohammed Mohier, Cairo University

Comparative Efficacy of Reflexology and Progressive Muscle Relaxation in Mitigating Fatigue Among Hemodialysis Patients

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 between reflexology and progressive muscle relaxation techniques in reducing fatigue levels among patients undergoing hemodialysis?

Participants 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 control group.

Fatigue and sleep quality will be measured before and after the intervention using:

Fatigue Severity Scale (FSS) Pittsburgh Sleep Quality Index (PSQI) Epworth Sleepiness Scale (ESS)

This study aims to offer a safe, low-cost, non-pharmacological method that can help hemodialysis patients reduce fatigue and improve sleep quality.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

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
    • Sharqia Governorate
      • Zagazig, Sharqia Governorate, Egypt, 44654
        • El Hussainiya Central Hospital - Nephrology Unit
        • Contact:

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:

  • 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

Exclusion Criteria:

  • 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 surgery.

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
Other: control
Other: Control
The participants will be observed for 12 weeks while continuing taking their prescribed medications and following standard nutritional guidelines recommended for patients with chronic kidney disease.
Experimental: Reflexology
Behavioral: reflexology
This group will receive reflexology on feet; each session lasts 20 minutes. 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.
Experimental: progressive muscle relaxation
Behavioral: progressive muscle relaxation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Fatigue Severity Scale (FSS) at 12 weeks
Time Frame: Baseline and after 12 weeks of intervention
The Fatigue Severity Scale is a 9-item questionnaire used to assess the severity of fatigue and its impact on daily functioning. The total score ranges from 1 to 7, with higher scores indicating greater fatigue severity and worse outcomes.
Baseline and after 12 weeks of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) at 12 weeks
Time Frame: Baseline and after 12 weeks of intervention
The Pittsburgh Sleep Quality Index (PSQI) is a questionnaire used to assess sleep quality. It includes 19 items organized into 7 components, which generate a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality.
Baseline and after 12 weeks of intervention
Change from baseline in Epworth Sleepiness Scale (ESS) at 12 weeks
Time Frame: Baseline and after 12 weeks of intervention
The Epworth Sleepiness Scale (ESS) is an 8-item questionnaire used to assess daytime sleepiness. Scores range from 0 to 24, with higher scores indicating greater daytime sleepiness and worse outcomes.
Baseline and after 12 weeks of intervention

Collaborators and Investigators

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

Sponsor

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 (Estimated)

June 1, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

May 4, 2026

First Submitted That Met QC Criteria

May 4, 2026

First Posted (Actual)

May 8, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/005983

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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