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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Low-İntensity Combined Exercises on Fatigue, Balance and Quality of Life in Patients With Early Stage ALS

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Other: Supervised exercise
* Other: Home exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised-exercise group<br>This group will be given combined low-intensity exercises under the supervision of a physiotherapist. | Other: Supervised exercise<br>* The supervised group will be given 10 minutes of warm-up, 10 minutes of breathing exercises, 20 minutes of low endurance combined exercises (stretching, strengthening, strength exercises), 10 minutes of balance and walking training, and 10 minutes of cool-down exercises. Exercise will be applied for 1 hour a day, 3 days a week for 6 weeks.<br>|
| Experimental: Home-exercise group<br>This group will exercise at home without the supervision of a physiotherapist. | Other: Home exercise<br>* The home group will be given 10 minutes of warm-up, 10 minutes of breathing exercises, 20 minutes of low endurance combined exercises (stretching, strengthening, strength exercises), 10 minutes of balance and walking training, and 10 minutes of cool-down exercises. Exercise will be applied for 1 hour a day, 3 days a week for 6 weeks in the home.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The fatigue severity scale (FSS) | 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. | Baseline, (one week before intervention) | 
| The fatigue severity scale (FSS) | 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. | Post-intervention (7th week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Balance Scale (BBS) | 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. | Baseline, (one week before intervention) | 
| Berg Balance Scale (BBS) | 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. | Post-intervention (7th week) | 
| Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) | The ALSAQ-40 provides scores for 5 scales: physical mobility, activities of daily living and independence, eating and drinking, communication, and emotional reactions. | Baseline, (one week before intervention) | 
| Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) | The ALSAQ-40 provides scores for 5 scales: physical mobility, activities of daily living and independence, eating and drinking, communication, and emotional reactions. | Post-intervention (7th week) | 
| ALS Functional Rating Scale Revised (ALSFRS-R) | ALSFRS-R measures activities of daily living (ADL) and global function for patients with Amyotrophic Lateral Sclerosis. | Baseline, (one week before intervention) | 
| ALS Functional Rating Scale Revised (ALSFRS-R) | ALSFRS-R measures activities of daily living (ADL) and global function for patients with Amyotrophic Lateral Sclerosis. | Post-intervention (7th week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amyotrophic lateral sclerosis, balance, fatigue, quality of life