Hemodialysis PatientNCT07276828
Effect of Autogenic Training on Hemodialysis Patients
A study testing Autogenic training and conventional physical therapy and hemodialysis care in people with Hemodialysis Patient and Restless Leg Syndrome (RLS), run by Cairo University at 1 site in Egypt.
Trial summary
goal of this interventional study to investigate the effect of autogenic training on sleep disturbance , restless leg syndrome and fatigue on hemodialysis patient Is there any significant effect of autogenic training on restless leg syndrome, sleep disturbance and fatigue in patients with hemodialysis? The… Read more about this study
- Who is it for?
- Ages 45 to 55 years
- Conditions the study is for
- Hemodialysis Patient, Restless Leg Syndrome (RLS), Fatigue
- What is being tested?
- Autogenic training and conventional physical therapy and hemodialysis care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2025to 15 May 2027
- 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 45 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 45 and 55 years.
- Body Mass Index (BMI) between 25.0 and 29.9 kg/m².
- Clinically and medically stable.
- On hemodialysis for at least 6 months prior to enrollment.
- Diagnosed with chronic kidney disease (CKD), defined by one or more of the following:
- Evidence of kidney damage (e.g., albuminuria), or
- Decreased kidney function with glomerular filtration rate (GFR) < 60 mL/min/1.73 m² for ≥ 3 months, irrespective of clinical diagnosis.
- Systolic blood pressure < 140 mmHg, diastolic blood pressure < 90 mmHg, and heart rate < 80 bpm.
Who cannot join
- Uncontrolled pulmonary disease.
- Severe vascular complications (e.g., critical limb ischemia).
- Unstable angina.
- Uncontrolled cardiac arrhythmia.
- Decompensated heart failure.
- Cognitive impairment.
- Participants who miss more than two weeks of the program or request termination.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alaa Mohamed Naguib, Lecturer contact
Egypt1 site
Faculity of physical therapy
Cairo, 11722
Zainab Khamis, M.sc student, +201147452255, zizig2382@gmail.com
About this study
Official title: Effect Of Autogenic Training On Restless Leg Syndrome And Sleep Disturbance In Hemodialysis
goal of this interventional study to investigate the effect of autogenic training on sleep disturbance , restless leg syndrome and fatigue on hemodialysis patient Is there any significant effect of autogenic training on restless leg syndrome, sleep disturbance and fatigue in patients with hemodialysis?
The intervention will include structured autogenic training sessions, and outcomes such as sleep quality and RLS severity and fatigue will be evaluated after 8 weeks of autogenic training on hemodialysis patients .
Read the detailed description
Hemodialysis patients always face various problems such as fatigue and sleep disturbance due to the chronic nature and side effects of hemodialysis, which negatively affect their quality of life A variety of treatment regimens can be chosen to initially relieve symptoms of patients currently with RLS and fatigue, among available regimes, pharmacological treatments are mainly selected for cases with severe RLS, which, at times, lead to serious complications It is hypothesized that these patients, according to the above implications, require a treatment suitable to their somatopsychic necessity, that autogenic training should perform being a method of choice for these types of issues Few clinical trials have examined the efficacy of autogenic training in patients undergoing hemodialysis that suffering from fatigue, restless syndrome and sleep disturbance, this approach could be incorporated into routine care protocols, enhancing patient comfort, promoting self-management, and reducing reliance on medications and their complications.
- Being tested
- Autogenic training, conventional physical therapy and hemodialysis care
- Medical subject headings
- Restless Legs Syndrome, Fatigue, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogenic trainingBehavioural
The Autogenic Training Program is a standardized mind-body relaxation technique that uses self-induced verbal formulas and passive concentration to promote autonomic regulation. The intervention includes guided sessions with 6 main exercises , The first exercise aims to relax muscles by repeating a verbal formula, "my right arm is heavy," emphasising heaviness. then feeling warm, initiated by the instruction ''my right arm is warm'', followed by cardiac activity using the formula ''my heartbeat is calm and regular''. Then follows passive concentration on the respiratory mechanism with the formula ''it breathes me'', then on warmth around the abdominal region with ''my solar plexus is warm'' and finally on coolness in the cranial region with ''my forehead is cool and clear'' . Participants will receive supervised training sessions followed by home practice instructions to enhance relaxation response and reduce physiological stress. in addition to conventional physiotherapy program
conventional physical therapy and hemodialysis careOther
control group will receive a conventional physiotherapy program that includes stretching exercises, strengthening exercises, range-of-motion training, and standard therapeutic procedures routinely used for patients with similar conditions. The sessions will follow a structured protocol delivered by a physiotherapist, without including any relaxation or autogenic training components.
| Study group | Role | What they receive |
|---|---|---|
| experimental group (autogenic training) | Experimental | 27 patients of both gender will receive the Autogenic Training program in addition to conventional physiotherapy and routin hemodialysis care . The intervention includes guided sessions of autogenic relaxation exercises focusing on breathing regulation, muscle relaxation, and self-induced calming techniques. The sessions will be performed [3] times per week for [8] weeks. The aim of this intervention is to improve sleep quality and reduce symptoms of restless leg syndrome and fatigue in hemodialysis patients. Receives: Behavioral: Autogenic training |
| conrol group | Active comparator | 27 Participants in this group will receive the conventional physiotherapy program routinely provided for hemodialysis patients, with no additional relaxation or autogenic training techniques. This group will be used to compare the effects of adding Autogenic Training to standard physiotherapy. Receives: Other: conventional physical therapy and hemodialysis care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dialysis adequacy
Dialysis adequacy will be assessed using URR (Urea Reduction Ratio) measured pre- and post-intervention to determine the effectiveness of the treatment in improving hemodialysis efficiency."
Measured: 8 weeks
Secondary outcomes (3)
sleep disturbance
Sleep disturbance will be assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire. Changes in total score and specific subcomponents (sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction) will be measured before and after the intervention.", each rated on a 0 to 3 scale, with higher scores implying greater difficulties. PSQI < 5 indicates good sleep quality; PSQI ≥ 5
Measured: 8 weeks
restless leg syndrome
Restless Leg Syndrome will be assessed using the International Restless Legs Syndrome Study Group (IRLSSG) rating scale. Severity and frequency of symptoms will be measured at baseline and after the intervention to evaluate improvement IRRLSSG severity questionnaire consisting of ten questions . In this questionnaire, all the answers have a score ranging from 0 (corresponding to "none") to 4 (corresponding to "very large") and the final score represents the sum of the answers of the ten questions, 0 to 10 points, light; 11 to 20 points, moderate; 21 to 30 points, serious; and 31 to 40 points, very serious
Measured: 8 weeks
fatigue
Fatigue will be assessed using the Fatigue assessment Scale (FAS). Changes in severity and impact on daily activities will be measured at baseline and after the intervention.
It is a standardized 10-item Likert scale ranging from 1 ("never") to 5 ("always"). It is used to assess the symptoms of fatigue. The tool reliability was 0.96. Each item of the FAS is answered using a five-point scale. Total scores range from 10 to 50, where score 10 indicates the mildest level of fatigue and score 50 denotes the highest level of fatigue among the participants
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis PatientStudies 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
- Model description
- Two parallel groups: an intervention group receiving autogenic training and a control group receiving hemodialysis
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zainab Gamal Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276828
- Sponsor's protocol ID
- P.T.REC/012/006063
- Status last verified
- Nov 2025
- First submitted
- 30 Nov 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Autogenic Training On Restless Leg Syndrome And Sleep Disturbance In Hemodialysis
- ClinicalTrials.gov ID
- NCT07276828
- Acronym / sponsor ID
- P.T.REC/012/006063
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 11 Dec 2025 (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.
goal of this interventional study to investigate the effect of autogenic training on sleep disturbance , restless leg syndrome and fatigue on hemodialysis patient Is there any significant effect of autogenic training on restless leg syndrome, sleep disturbance and fatigue in patients with hemodialysis?
The intervention will include structured autogenic training sessions, and outcomes such as sleep quality and RLS severity and fatigue will be evaluated after 8 weeks of autogenic training on hemodialysis patients .
Detailed description
Hemodialysis patients always face various problems such as fatigue and sleep disturbance due to the chronic nature and side effects of hemodialysis, which negatively affect their quality of life A variety of treatment regimens can be chosen to initially relieve symptoms of patients currently with RLS and fatigue, among available regimes, pharmacological treatments are mainly selected for cases with severe RLS, which, at times, lead to serious complications It is hypothesized that these patients, according to the above implications, require a treatment suitable to their somatopsychic necessity, that autogenic training should perform being a method of choice for these types of issues Few clinical trials have examined the efficacy of autogenic training in patients undergoing hemodialysis that suffering from fatigue, restless syndrome and sleep disturbance, this approach could be incorporated into routine care protocols, enhancing patient comfort, promoting self-management, and reducing reliance on medications and their complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel groups: an intervention group receiving autogenic training and a control group receiving hemodialysis
| Arm | Type | Receives |
|---|---|---|
| experimental group (autogenic training) | Experimental | Behavioral: Autogenic training27 patients of both gender will receive the Autogenic Training program in addition to conventional physiotherapy and routin hemodialysis care . The intervention includes guided sessions of autogenic relaxation exercises focusing on breathing regulation, muscle relaxation, and self-induced calming techniques. The sessions will be performed [3] times per week for [8] weeks. The aim of this intervention is to improve sleep quality and reduce symptoms of restless leg syndrome and fatigue in hemodialysis patients. |
| conrol group | Active comparator | Other: conventional physical therapy and hemodialysis care27 Participants in this group will receive the conventional physiotherapy program routinely provided for hemodialysis patients, with no additional relaxation or autogenic training techniques. This group will be used to compare the effects of adding Autogenic Training to standard physiotherapy. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age between 45 and 55 years.
- Body Mass Index (BMI) between 25.0 and 29.9 kg/m².
- Clinically and medically stable.
- On hemodialysis for at least 6 months prior to enrollment.
- Diagnosed with chronic kidney disease (CKD), defined by one or more of the following:
Key exclusion criteria (7 listed)
- Uncontrolled pulmonary disease.
- Severe vascular complications (e.g., critical limb ischemia).
- Unstable angina.
- Uncontrolled cardiac arrhythmia.
- Decompensated heart failure.
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 |
|---|---|---|
| Autogenic trainingThe Autogenic Training Program is a standardized mind-body relaxation technique that uses self-induced verbal formulas and passive concentration to promote autonomic regulation. The intervention includes guided sessions with 6 main exercises , The first exercise aims to relax muscles by repeating a verbal formula, "my right arm is heavy," emphasising heaviness. then feeling warm, initiated by the instruction ''my right arm is warm'', followed by cardiac activity using the formula ''my heartbeat is calm and regular''. Then follows passive concentration on the respiratory mechanism with the formula ''it breathes me'', then on warmth around the abdominal region with ''my solar plexus is warm'' and finally on coolness in the cranial region with ''my forehead is cool and clear'' . Participants will receive supervised training sessions followed by home practice instructions to enhance relaxation response and reduce physiological stress. in addition to conventional physiotherapy program | Behavioural | experimental group (autogenic training) |
| conventional physical therapy and hemodialysis carecontrol group will receive a conventional physiotherapy program that includes stretching exercises, strengthening exercises, range-of-motion training, and standard therapeutic procedures routinely used for patients with similar conditions. The sessions will follow a structured protocol delivered by a physiotherapist, without including any relaxation or autogenic training components. | Other | conrol group |
Primary outcome
Dialysis adequacy
Time frame: 8 weeks
Dialysis adequacy will be assessed using URR (Urea Reduction Ratio) measured pre- and post-intervention to determine the effectiveness of the treatment in improving hemodialysis efficiency."
3 secondary outcomes
sleep disturbance
Time frame: 8 weeks
restless leg syndrome
Time frame: 8 weeks
fatigue
Time frame: 8 weeks
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 22 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Alaa Mohamed Naguib, Lecturer contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autogenic training and conventional physical therapy and hemodialysis care in people with Hemodialysis Patient and Restless Leg Syndrome (RLS), 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 8 inclusion and 7 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 22 Dec 2025. 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 Zainab Gamal Mohamed khamis, B.sc physical therapy (+201147452255, zizig2382@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dialysis adequacy (time frame: 8 weeks). 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 22 Dec 2025.