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Sponsored by: |
Radboud University |
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Information provided by: | Radboud University |
ClinicalTrials.gov Identifier: | NCT00160004 |
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 |
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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 |
Estimated Study Completion Date: | September 2009 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jessica Pastoor, Msc PT | +3124-3614883 | J.Pastoor@fysio.umcn.nl |
Netherlands, Gelderland | |
Department of Allied health Occupations, Radboud University Nijmegen Medical Centre | Recruiting |
Nijmegen, Gelderland, Netherlands, 6500 HB | |
Contact: Jessica Pastoor, MSc PT +31243614883 J.Pastoor@fysio.umcn.nl | |
Sub-Investigator: Jessica Pastoor, MSc PT |
Principal Investigator: | Marten Munneke, PhD | Institute of Neurology, Radboud University Nijmegen Medical Centre, The Netherlands |
Study ID Numbers: | ALSICEJ1 |
Study First Received: | September 9, 2005 |
Last Updated: | July 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00160004 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Amyotrophic Lateral Sclerosis Exercise Fatigue Quality-of-life |
Fatigue Spinal Cord Diseases Central Nervous System Diseases Quality of Life Sclerosis Degenerative motor system disease Neurodegenerative Diseases |
Motor neuron disease Amyotrophic lateral sclerosis Neuromuscular Diseases Amyotrophic Lateral Sclerosis Lou Gehrig's disease Motor Neuron Disease |
Pathologic Processes Nervous System Diseases |