Effect of Autogenic Training on Hemodialysis Patients

NCT07276828 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/006063
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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 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 .

Conditions

Hemodialysis Patient; Restless Leg Syndrome (RLS); Fatigue; Sleep Disturbance

Outcome Measures

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."

  8 weeks

Secondary Outcomes (3)

• sleep disturbance

  8 weeks

• restless leg syndrome

  8 weeks

• fatigue

  8 weeks

Study Arms (2)

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.

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.

Other: conventional physical therapy and hemodialysis care

Interventions

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

experimental group (autogenic training)

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.

conrol group

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculity of physical therapy

Cairo, 11722, Egypt

Location

MeSH Terms

Conditions

Restless Legs Syndrome; Fatigue; Parasomnias

Interventions

Autogenic Training

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Zainab Gamal Mohamed khamis, B.sc physical therapy

CONTACT

+201147452255; zizig2382@gmail.com

Alaa Mohamed Naguib, Lecturer

CONTACT

+20 10 92224967

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

Model Details: Two parallel groups: an intervention group receiving autogenic training and a control group receiving hemodialysis

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 11, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)