The Effect of Intensive Controlled Exercise in the Early Stages of Amyotrophic Lateral Sclerosis
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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 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | The Effect of Intensive Controlled Exercise in the Early Stages of Amyotrophic Lateral Sclerosis |
- Cardiorespiratory fitness measured with Astrand submaximal test
- 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
- Fatigue measured with CIS Questionnaire
- Pulmonary function measured with FVC
| 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:
- Older dan 18 years Written Informed Consent Don't use walking adds such as a cane Patients must met El Escorial criteria for probable or definite ALS
Exclusion Criteria:
- Patients who are depending on intermittent or continuous mechanical ventilation Patients who are not able to understand and conform to the instructions Patients who already perform an exercise programme that can compare with our study Patients who have severe cardiopulmonary problems, DM or other problems concerning connective tissue.
Contacts and Locations| Netherlands | |
| 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
Publications:
| ClinicalTrials.gov Identifier: | NCT00160004 History of Changes |
| Other Study ID Numbers: | ALSICEJ1 |
| Study First Received: | September 9, 2005 |
| Last Updated: | June 5, 2009 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Radboud University:
|
Amyotrophic Lateral Sclerosis Exercise Fatigue Quality-of-life |
Additional relevant MeSH terms:
|
Amyotrophic Lateral Sclerosis Sclerosis Motor Neuron Disease Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases |
Neurodegenerative Diseases TDP-43 Proteinopathies Neuromuscular Diseases Proteostasis Deficiencies Metabolic Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013