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Effect of Autogenic Training on Hemodialysis Patients

NCT ID: NCT07276828

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2027-05-15

Brief Summary

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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

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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.

Conditions

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Hemodialysis Patient Restless Leg Syndrome (RLS) Fatigue Sleep Disturbance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two parallel groups: an intervention group receiving autogenic training and a control group receiving hemodialysis
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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experimental group (autogenic training)

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.

Group Type EXPERIMENTAL

Autogenic training

Intervention Type 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

conrol group

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.

Group Type ACTIVE_COMPARATOR

conventional physical therapy and hemodialysis care

Intervention Type 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.

Interventions

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Autogenic training

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

Intervention Type BEHAVIORAL

conventional physical therapy and hemodialysis care

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Zainab Gamal Mohamed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculity of physical therapy

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Zainab Gamal Mohamed khamis, B.sc physical therapy

Role: CONTACT

Phone: +201147452255

Email: [email protected]

Alaa Mohamed Naguib, Lecturer

Role: CONTACT

Phone: +20 10 92224967

Facility Contacts

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Zainab Khamis, M.sc student

Role: primary

Other Identifiers

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P.T.REC/012/006063

Identifier Type: -

Identifier Source: org_study_id