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| Sponsor: | Radboud University |
|---|---|
| Information provided by: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT00160004 |
Purpose
Amyotrophic Lateral Sclerosis (ALS) is a progressive neurological disorder characterized by amongst others asymmetric muscle weakness, respiratory insufficiency and spasticity. The disease is usually fatal within 2-3 years and until now there is no cure. ALS patients are usually supported by a multidisciplinary team. One of the members of this team is the physical therapist. The aim of physical therapy might be to enhance or to preserve cardiovascular fitness and muscle strength. Some authors suggest, however, that a moderate to high intensive exercise programme might lead to overuse weakness (an undesired fast progression of muscle weakness). The primary objective of this study is therefore to investigate whether regular moderate to high intensity exercise program in ALS can maintain or optimize cardiorespiratory fitness and muscle strength. A secondary objective is to investigate whether such a programme leads to overuse weakness and if there is a positive influence on patient's disability, fatigue and quality of life.
| Condition | Intervention | Phase |
|---|---|---|
|
Amyotrophic Lateral Sclerosis |
Behavioral: Intensive Controlled Exercise |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment |
| Official Title: | The Effect of Intensive Controlled Exercise in the Early Stages of Amyotrophic Lateral Sclerosis |
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2006 |
| Study Completion Date: | December 2008 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Netherlands, Gelderland | |
| Department of Allied health Occupations, Radboud University Nijmegen Medical Centre | |
| Nijmegen, Gelderland, Netherlands, 6500 HB | |
| Principal Investigator: | Marten Munneke, PhD | Institute of Neurology, Radboud University Nijmegen Medical Centre, The Netherlands |
More Information
| Study ID Numbers: | ALSICEJ1 |
| Study First Received: | September 9, 2005 |
| Last Updated: | June 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00160004 History of Changes |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
Amyotrophic Lateral Sclerosis Exercise Fatigue Quality-of-life |
|
Pathologic Processes Neuromuscular Diseases Spinal Cord Diseases Amyotrophic Lateral Sclerosis Nervous System Diseases |
Central Nervous System Diseases Sclerosis Neurodegenerative Diseases Motor Neuron Disease |