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NCT Number: NCT07575607

Reflexology Versus Progressive Muscle Relaxation for Fatigue in 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.

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Key information

Conditions

End Stage Renal Failure, Hemodialysis Chronic Disease Disease Attributes Dyssomnias Fatigue Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Mental Disorders Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Urogenital Diseases Urologic Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

El Hussainiya Central Hospital - Nephrology Unit

Zagazig, Sharqia Governorate, 44654, Egypt

Location contact

selim

CONTACT

[email protected]

+201018707210

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Reflexology

Behavioral

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.

Progressive Muscle Relaxation

Behavioral

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.

Control

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

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

Farah M. selim

CONTACT

[email protected]

+201018707210

Hania Muhammad selim

CONTACT

[email protected]

+201018694969

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: PMR-HD

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 8, 2026
Registry last updated
May 12, 2026

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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