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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supervised-exercise group | Experimental | This group will be given combined low-intensity exercises under the supervision of a physiotherapist. |
|
| Home-exercise group | Experimental | This group will exercise at home without the supervision of a physiotherapist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supervised exercise | Other | 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. |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Professor Ela Tarakci, PHD | Contact | +905422175730 | etarakci@iuc.edu.tr | |
| Xhennet Muriqi | Contact | +905314856657 | xhennet.muriqi@ogr.iuc.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Professor Ela Tarakci | Istanbul University - Cerrahpasa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University-Cerrahpasa | Recruiting | Istanbul | Bakirkoy | 34000 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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|
| Home exercise | Other | 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. |
|
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) |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |