End Stage Renal Failure, HemodialysisPMR-HDNCT07575607
Reflexology Versus Progressive Muscle Relaxation for Fatigue in Hemodialysis Patients
A study testing reflexology and progressive muscle relaxation in people with End Stage Renal Failure, Hemodialysis and Fatigue, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- End Stage Renal Failure, Hemodialysis, Fatigue
- What is being tested?
- reflexology and progressive muscle relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
El Hussainiya Central Hospital - Nephrology Unit
Zagazig, Sharqia Governorate, 44654
selim, +201018707210, farahselim199@gmail.com
About this study
Official title: 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:
Read more
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
- Being tested
- reflexology, progressive muscle relaxation, Control
- 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
- Medical subject headings
- Renal Insufficiency, Chronic, Fatigue, Sleep Initiation and Maintenance Disorders, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reflexologyBehavioural
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 relaxationBehavioural
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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Reflexology | Experimental | Not described Receives: Behavioral: reflexology |
| progressive muscle relaxation | Experimental | Not described Receives: Behavioral: progressive muscle relaxation |
| control | Other | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and after 12 weeks of intervention
Secondary outcomes (2)
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) at 12 weeks
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.
Measured: Baseline and after 12 weeks of intervention
Change from baseline in Epworth Sleepiness Scale (ESS) at 12 weeks
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.
Measured: Baseline and after 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Failure, HemodialysisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farah Mohammed Mohammed Mohier, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575607
- Sponsor's protocol ID
- P.T.REC/012/005983
- Acronym
- PMR-HD
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Reflexology and Progressive Muscle Relaxation in Mitigating Fatigue Among Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07575607
- Acronym / sponsor ID
- PMR-HD / P.T.REC/012/005983
- Conditions
- End Stage Renal Failure, Hemodialysis, Fatigue
- Keywords
- Reflexology, Relaxation, Fatigue, Sleep quality, Non-pharmacological interventions, Hemodialysis, End-stage renal failure, Progressive muscle relaxation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 8 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reflexology | Experimental | Behavioral: reflexology |
| progressive muscle relaxation | Experimental | Behavioral: progressive muscle relaxation |
| control | Other | Other: Control |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reflexologyThis 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. | Behavioural | Reflexology |
| progressive muscle relaxationThis 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. | Behavioural | progressive muscle relaxation |
| ControlThe 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. | Other | control |
Primary outcome
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.
2 secondary outcomes
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) at 12 weeks
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reflexology and progressive muscle relaxation in people with End Stage Renal Failure, Hemodialysis and Fatigue, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Farah M. selim (+201018707210, farahsalleem1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Fatigue Severity Scale (FSS) at 12 weeks (time frame: Baseline and after 12 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.