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The Effect of Intensive Controlled Exercise in the Early Stages of Amyotrophic Lateral Sclerosis

This study is currently recruiting participants.
Study NCT00160004.   Last updated on July 30, 2007.   Information provided by Radboud University

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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.

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
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:

  • 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.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Jessica Pastoor, Msc PT     +3124-3614883     J.Pastoor@fysio.umcn.nl    
Location Countries  Netherlands
Administrative Information Fields
NCT ID  NCT00160004
Organization ID ALSICEJ1
Secondary IDs ††
Study Sponsor  Radboud University
Collaborators ††
Investigators 
Principal Investigator:     Marten Munneke, PhD     Institute of Neurology, Radboud University Nijmegen Medical Centre, The Netherlands    
Information Provided By Radboud University
Verification Date July 2007
First Received Date  September 9, 2005
Last Updated Date July 30, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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