The Effect of Low-İntensity Combined Exercises in Patients With Early Stage ALS.

Istanbul University - Cerrahpasa (IUC)

Status: Enrolling

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Other: Home exercise; Other: Supervised exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05716074

E-74555795-050.01.04-531483

Details and patient eligibility

About

The aim of this study is to investigate the effects of low-intensity combined exercises on balance, fatigue and quality of life applied to patients with ALS.

Full description

Balance problems and signs of fatigue are seen in early-stage ALS patients. While balance problems lead to falls in ALS patients, fatigue also affects a part of their lives. Studies investigating the effects of low-intensity exercise on fatigue, balance, and quality of life in patients with early-stage ALS are rare. This study will investigate the effects of low-intensity combined exercises on balance, fatigue and quality of life in patients with ALS.

Participants will be randomly divided into Supervised and Home groups. Low-intensity exercises will be applied to the home exercise group as a home program for 1 hour a day, 3 days a week, for 6 weeks. Low-intensity exercises will be applied to the supervised exercise group for 1 hour a day, 3 days a week for 6 weeks, accompanied by a physiotherapist. Evaluations will be made at the beginning and at the end of the treatment.

Berg Balance Scale, Fatigue Severity Scale (FSS), Amyotrophic Lateral Sclerosis Assessment Questionnaire-40 (ALSAQ-40) and revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) will be used to evaluate patients before and 6 weeks after treatment.

Enrollment: 30 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Being diagnosed with early-stage ALS by a neurologist
• Disease duration in the range of 1-18 months
• ALSFRS-R score > 24 higher
• Without infectious disease
• Saturation >95
• Heart rate <92

Exclusion criteria

• History of other neurological disease
• Inability to walk
• With mechanical ventilation
• People with Heart and Respiratory Insufficiency
• People with neuropsychological or cognitive impairment
• Dyspnea after ALS

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Supervised-exercise group

Experimental group

Description:

This group will be given combined low-intensity exercises under the supervision of a physiotherapist.

Treatment:

Other: Supervised exercise

Home-exercise group

Experimental group

Description:

This group will exercise at home without the supervision of a physiotherapist.

Treatment:

Other: Home exercise