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

Not Applicable

Recruiting

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Other: Supervised exercise; Other: Home exercise

• Registration Number: NCT05716074
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2022-11-15
• Status Verified: 2023-01
• Study First Submitted: 2023-01-29
• Study First Submitted QC: 2023-01-29
• Last Update Submitted: 2023-01-29
• Study First Posted: 2023-02-08
• Last Update Posted: 2023-02-08
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supervised-exercise group	Supervised exercise	This group will be given combined low-intensity exercises under the supervision of a physiotherapist.
Home-exercise group	Home exercise	This group will exercise at home without the supervision of a physiotherapist.

Primary Outcome Measures

Name	Time	Method
The fatigue severity scale (FSS)	Post-intervention (7th week)	FSS is a self-report scale of nine items examining motivation, physical function, responsibilities, work, family or social life, exercise, fatigue, frequency of problems, and priority of symptoms.

Secondary Outcome Measures

Name	Time	Method
Berg Balance Scale (BBS)	Post-intervention (7th week)	The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40)	Post-intervention (7th week)	The ALSAQ-40 provides scores for 5 scales: physical mobility, activities of daily living and independence, eating and drinking, communication, and emotional reactions.
ALS Functional Rating Scale Revised (ALSFRS-R)	Post-intervention (7th week)	ALSFRS-R measures activities of daily living (ADL) and global function for patients with Amyotrophic Lateral Sclerosis.

Trial Locations

Locations (1)

Istanbul University-Cerrahpasa; 🇹🇷 Istanbul, Bakirkoy, Turkey