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The Effect of Intensive Controlled Exercise in the Early Stages of Amyotrophic Lateral Sclerosis
This study has been terminated.
( problems with including patients and a large multicenter Trial is now starting as follow-up )
Study NCT00160004   Information provided by Radboud University
First Received: September 9, 2005   Last Updated: June 5, 2009   History of Changes

September 9, 2005
June 5, 2009
March 2006
 
Cardiorespiratory fitness measured with Astrand submaximal test
Muscle Strength measured with MVIC (Maximum Voluntary Isometric Contraction)
Complete list of historical versions of study NCT00160004 on ClinicalTrials.gov Archive Site
  • 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
  • Cardiorespiratory fitness measured with Astrand submaximal test
  • Functional status measured with ALS-FRS-r Rating scale
  • Quality of life with ALS-AQ40 Questionnaire AND COOP-WONCA
  • Fatique measured with CIS Questionnaire
  • Pulmonary function measured with FVC
 
The Effect of Intensive Controlled Exercise in the Early Stages of Amyotrophic Lateral Sclerosis
The Effect of Intensive Controlled Exercise in the Early Stages of Amyotrophic Lateral Sclerosis

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.

 
Phase I, Phase II
Interventional
Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
Amyotrophic Lateral Sclerosis
Behavioral: Intensive Controlled Exercise
 
Drory VE, Goltsman E, Reznik JG, Mosek A, Korczyn AD. The value of muscle exercise in patients with amyotrophic lateral sclerosis. J Neurol Sci. 2001 Oct 15;191(1-2):133-7.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
20
December 2008
 

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00160004
 
ALSICEJ1
Radboud University
 
Principal Investigator: Marten Munneke, PhD Institute of Neurology, Radboud University Nijmegen Medical Centre, The Netherlands
Radboud University
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP