Effect of Autogenic Training on Hemodialysis Patients

Cairo University (CU)

Status: Not yet enrolling

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

Treatments: Other: conventional physical therapy and hemodialysis care; Behavioral: Autogenic training

Study type: Interventional

Funder types: Other

Identifiers

NCT07276828

P.T.REC/012/006063

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 54 estimated patients

Sex: All

Ages: 45 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

experimental group (autogenic training)

Experimental group

Description:

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.

Treatment:

Behavioral: Autogenic training

conrol group

Active Comparator group

Description:

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.

Treatment:

Other: conventional physical therapy and hemodialysis care