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)
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00160004
First received: September 9, 2005
Last updated: June 5, 2009
Last verified: June 2009
  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

Resource links provided by NLM:


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
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Netherlands
Department of Allied health Occupations, Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
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
Central Nervous System Diseases
Metabolic Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Pathologic Processes
Proteostasis Deficiencies
Spinal Cord Diseases
TDP-43 Proteinopathies

ClinicalTrials.gov processed this record on October 23, 2014