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NCT Number: NCT07276828

Effect of Autogenic Training on Hemodialysis Patients

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 .

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Key information

Conditions

Hemodialysis Patient Dyssomnias Fatigue Mental Disorders Nervous System Diseases Parasomnias Pathological Conditions, Signs and Symptoms Restless Leg Syndrome (RLS) Restless Legs Syndrome Signs and Symptoms Sleep Disorders, Intrinsic Sleep Disturbance Sleep Wake Disorders

Age range

45 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

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.

Treatment and study plan

Autogenic Training

Behavioral

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 care

Other

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.

Primary outcomes

  1. 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."

Secondary outcomes

  1. sleep disturbance

    Time frame: 8 weeks

    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

  2. restless leg syndrome

    Time frame: 8 weeks

    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

  3. fatigue

    Time frame: 8 weeks

    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

Study contacts

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

Alaa Mohamed Naguib, Lecturer

CONTACT

+20 10 92224967

Zainab Gamal Mohamed khamis, B.sc physical therapy

CONTACT

[email protected]

+201147452255

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect Of Autogenic Training On Restless Leg Syndrome And Sleep Disturbance In Hemodialysis

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 11, 2025
Registry last updated
Dec 22, 2025

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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