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| Descriptive Information Fields | |||||
| Brief Title † | The Effect of Intensive Controlled Exercise in the Early Stages of Amyotrophic Lateral Sclerosis | ||||
| Official Title † | The Effect of Intensive Controlled Exercise in the Early Stages of Amyotrophic Lateral Sclerosis | ||||
| Brief Summary | 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. |
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| Detailed Description | |||||
| Study Phase | Phase I, Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment | ||||
| Primary Outcome Measure † | Cardiorespiratory fitness measured with Astrand submaximal test | ||||
| Secondary Outcome Measure † | Muscle Strength measured with MVIC (Maximum Voluntary Isometric Contraction) Functional status measured with ALS-FRS-r Rating scale Quality of life with ALS-AQ40 Questionnaire AND COOP-WONCA Fatigue measured with CIS Questionnaire Pulmonary function measured with FVC |
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| Condition † | Amyotrophic Lateral Sclerosis | ||||
| Intervention † | Behavioral: Intensive Controlled Exercise | ||||
| MEDLINE PMIDs | 11677004 | ||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 20 | ||||
| Start Date † | March 2006 | ||||
| Completion Date | September 2009 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | Netherlands | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00160004 | ||||
| Organization ID | ALSICEJ1 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Radboud University | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Radboud University | ||||
| Verification Date | July 2007 | ||||
| First Received Date † | September 9, 2005 | ||||
| Last Updated Date | July 30, 2007 | ||||