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Effect of Autogenic Training on Hemodialysis Patients

ConditionsHemodialysis PatientRestless Leg Syndrome (RLS)FatigueSleep Disturbance
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-55
SponsorCairo University

About this trial

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 .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: experimental group (autogenic training)Experimental treatment 1 intervention
Group B: conrol groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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."

Time frame
8 weeks

Secondary outcomes

1

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

Time frame
8 weeks
2

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

Time frame
8 weeks
3

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

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

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