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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00160004
Recruitment Status : Terminated (problems with including patients and a large multicenter Trial is now starting as follow-up)
First Posted : September 12, 2005
Last Update Posted : June 8, 2009
Information provided by:
Radboud University

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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Behavioral: Intensive Controlled Exercise Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: The Effect of Intensive Controlled Exercise in the Early Stages of Amyotrophic Lateral Sclerosis
Study Start Date : March 2006
Actual Study Completion Date : December 2008

Primary Outcome Measures :
  1. Cardiorespiratory fitness measured with Astrand submaximal test

Secondary Outcome Measures :
  1. Muscle Strength measured with MVIC (Maximum Voluntary Isometric Contraction)
  2. Functional status measured with ALS-FRS-r Rating scale
  3. Quality of life with ALS-AQ40 Questionnaire
  4. Fatigue measured with CIS Questionnaire
  5. Pulmonary function measured with FVC

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00160004

Department of Allied health Occupations, Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Principal Investigator: Marten Munneke, PhD Institute of Neurology, Radboud University Nijmegen Medical Centre, The Netherlands

Publications: Identifier: NCT00160004     History of Changes
Other Study ID Numbers: ALSICEJ1
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: June 8, 2009
Last Verified: June 2009

Keywords provided by Radboud University:
Amyotrophic Lateral Sclerosis

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases