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

This study is currently recruiting participants.
Verified by Radboud University, July 2007

Sponsored by: Radboud University
Information provided by: Radboud University
ClinicalTrials.gov Identifier: NCT00160004
  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 I
Phase II

Genetics Home Reference related topics:   amyotrophic lateral sclerosis   

MedlinePlus related topics:   Amyotrophic Lateral Sclerosis    Exercise and Physical Fitness   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
Official Title:   The Effect of Intensive Controlled Exercise in the Early Stages of Amyotrophic Lateral Sclerosis

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Cardiorespiratory fitness measured with Astrand submaximal test

Secondary Outcome Measures:
  • 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

Estimated Enrollment:   20
Study Start Date:   March 2006
Estimated Study Completion Date:   September 2009

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160004

Contacts
Contact: Jessica Pastoor, Msc PT     +3124-3614883     J.Pastoor@fysio.umcn.nl    

Locations
Netherlands, Gelderland
Department of Allied health Occupations, Radboud University Nijmegen Medical Centre     Recruiting
      Nijmegen, Gelderland, Netherlands, 6500 HB
      Contact: Jessica Pastoor, MSc PT     +31243614883     J.Pastoor@fysio.umcn.nl    
      Sub-Investigator: Jessica Pastoor, MSc PT            

Sponsors and Collaborators
Radboud University

Investigators
Principal Investigator:     Marten Munneke, PhD     Institute of Neurology, Radboud University Nijmegen Medical Centre, The Netherlands    
  More Information

Publications:

Study ID Numbers:   ALSICEJ1
First Received:   September 9, 2005
Last Updated:   July 30, 2007
ClinicalTrials.gov Identifier:   NCT00160004
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  

Study placed in the following topic categories:
Fatigue
Spinal Cord Diseases
Central Nervous System Diseases
Quality of Life
Sclerosis
Degenerative motor system disease
Neurodegenerative Diseases
Motor neuron disease
Amyotrophic lateral sclerosis
Neuromuscular Diseases
Amyotrophic Lateral Sclerosis
Lou Gehrig's disease
Motor Neuron Disease

Additional relevant MeSH terms:
Pathologic Processes
Nervous System Diseases

ClinicalTrials.gov processed this record on September 04, 2008




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