- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00160004
The Effect of Intensive Controlled Exercise in the Early Stages of Amyotrophic Lateral Sclerosis
June 5, 2009 updated by: Radboud University Medical Center
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gelderland
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Nijmegen, Gelderland, Netherlands, 6500 HB
- Department of Allied health Occupations, Radboud University Nijmegen Medical Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Cardiorespiratory fitness measured with Astrand submaximal test
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Secondary Outcome Measures
Outcome Measure |
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Muscle Strength measured with MVIC (Maximum Voluntary Isometric Contraction)
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Functional status measured with ALS-FRS-r Rating scale
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Quality of life with ALS-AQ40 Questionnaire
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Fatigue measured with CIS Questionnaire
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Pulmonary function measured with FVC
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marten Munneke, PhD, Institute of Neurology, Radboud University Nijmegen Medical Centre, The Netherlands
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
June 8, 2009
Last Update Submitted That Met QC Criteria
June 5, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALSICEJ1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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