Reflexology Versus Progressive Muscle Relaxation for Fatigue in Hemodialysis Patients

NCT07575607 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005983
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

End Stage Renal Failure, Hemodialysis; Fatigue

Keywords

Reflexology; Relaxation; Fatigue; Sleep quality; Non-pharmacological interventions; Hemodialysis; End-stage renal failure; Progressive muscle relaxation; Fatigue Severity Scale; Pittsburgh Sleep Quality Index; Epworth Sleepiness Scale; Chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Fatigue Severity Scale (FSS) at 12 weeks

  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 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

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.

Reflexology

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.

control

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.

progressive muscle relaxation

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

El Hussainiya Central Hospital - Nephrology Unit

Zagazig, Sharqia Governorate, 44654, Egypt

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Fatigue; Sleep Initiation and Maintenance Disorders; Kidney Failure, Chronic

Interventions

Musculoskeletal Manipulations; Autogenic Training

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Hypnosis; Mind-Body Therapies; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Farah M. selim

CONTACT

+201018707210; farahsalleem1@gmail.com

Hania Muhammad selim

CONTACT

+201018694969; hania.mohier@gmail.com

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: Principal Investigator

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

EG (1)